Biopharmaceutics Answer Key-RED PACOP PDF

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Summary

This document contains a set of questions and answers related to biopharmaceutics, a branch of pharmacology focusing on the absorption, distribution, metabolism, and excretion (ADME) of drugs. The key concepts discussed include drug dissolution, absorption processes, and factors influencing bioavailability.

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BIOPHARMACEUTICS RED 5. For most drugs, which part of the gastrointestinal tract is the optimum site for 1. This corresponds to the time required for drug absorption after the oral administration? a drug to reach the...

BIOPHARMACEUTICS RED 5. For most drugs, which part of the gastrointestinal tract is the optimum site for 1. This corresponds to the time required for drug absorption after the oral administration? a drug to reach the a minimum effective concentration (MEC) A. Buccal cavity A. onset of action B. stomach B. intensity C. duodenum C. duration od action D. jejunum D. Cmax E. colon E. AUC 6. Which of the following can increase gastric emptying rate? 2. It is the delivery of the active pharmaceutical ingredients from a dosage A. administration of metoclopramide form into solution B. vigorous exercise A. Dissolution C. cold beverages B. Absorption D. lying in the left side C. Liberation E. consumption of high fat meal D.Permeation 7. Route of administration in which the drug D. Disposition (in lotion, ointment, cream, paste, or patch) is placed on the skin for systemic absorption 3. How much of a 500 mg dose is bioavailable if the administered drug has F of 75% A. Topical A. 375 mg B. intracutaneous B. 500 mg C. 125 mg C. Transdermal D. d.50 mg E. 5 mg D. Buccal 4. Which of the following is the major process of absorption for most drugs? E. epidermal A. Passive Diffusion 8. Metered dose aerosols are examples of which route of administration? B. Active transport A. intranasal C. Facilitated Diffusion B. inhalational D. Vesicular transport C. alveolar E. Convective transport D. peroral E. respiratory CORRECT ANSWER: B. Disintegration D. inhalational C. Gastric Emptying 9. Which of the following routes of D. Dissolution administration has/have no first-pass effect E. Dispersion I. buccal 13.For most conventional solid drug products, II. sublingual which of the following is the rate limiting step for bioavailability? III. oral A. Liberation IV. rectal B. Disintegration A. I only B. II only C. Solubility C. I & II D. d.III only D. Dissolution E. I, II and IV 10. Which of the following is the plasma level E. Attrition time curve of an open intravascular two- compartment model 14. These products are the first ones to be patented or granted certain exclusivities A. generic medicines B. innovator products C. multi source drug products D. market leader E. reference 11. If the AUC for the Phenobarbital 15. Which of the following products are administered orally by tablet is 6.5 mcg/mL x considered to be pharmaceutical equivalents? hr and the AUC for the Phenobarbital solution can give the same dose and route is 8.4 A. Mefenamic acid 250 mg cap & mcg/mL calculate the relative bioavailability of mefenamic acid 500 mg cap the drug. B. amlodipine besylate (innovator) 10 a. 129.23% d. 56. 38% mg tab & amlodipine besylate (generic) 10 mg tab b. 100% e. 43.62% C. amoxicillin 500 mg cap & amoxicillin c. 77.38% 250 mg/mL susp. 12. This is the process by which a solid drug D. Clindamycin HCl 300 mg cap & substance becomes dissolved in a solvent clindamycin phosphate 150 mg/mL amp x 4 mL A. Liberation E. Paracetamol (Brand A) 500 mg tab & E. e. I to IV paracetamol (Brand B) 500 mg cap 19. Among the following oral drug formulation, 16. Which of the following drug products are which is considered to be the most considered to be pharmaceutical alternatives? bioavailable? A. cephalexin 500 mg cap & cefalexin A. Solution 500 mg cap B. Suspension B. propranolol 10 mg tab (branded) & propranolol 10 mg tab (unbranded) C. Emulsion C. nifedipine 5 mg cap & nifedipine 20 D. Powder mg mg GITS tab E. Granule D. ranitidine HCl (local) 150 mg tab & 20. Dispensing ibuprofen instead of naproxen ranitidine HCl (imported) 150 mg tab is an example of: 17. This describes the passive diffusion of the A. generic dispensing drugs across the gastrointestinal blood barrier B. pharmaceutical substitution A. Fick’s First law C. pharmaceutical equivalence B. Noye’s-Whitney equation D. therapeutic equivalence C. Henderson-Hasselbach Equation E. therapeutic substitution 21. A drug has high solubility but low D. Clausius-Clapeyron Equation permeability may be classified based on the E. Raoult’s law Biopharmaceutics classification system as: 18. Bioequivalence can be assessed using A. Class 1 which of the following methods? B. Class 2 I. in vivo pharmacokinetics studies involving C. Class 3 plasma or urine drug concentrations as a function of time D. Class 4 II. In vivo pharmacodynamic studies E. Class 5 III. Comparative clinical trials 22. Which of the following physicochemical properties of a drug will result to a faster IV. Comparative in vitro studies dissolution rate? A. a.I only A. small surface area B. unionized form B. b. I,II C. high partition coefficient C. c. III only D. amorphous form E. large particle size D. d. I to II 23. in the BCS class the drug dissolves rapidly and is well absorbed and bioavailability problem is not expected for immediate-release E. partition coefficient drug products 26. This refers to the systemic availability of a A. Class 1 drug after extravascular administration compared to IV dosing. B. Class 2 A. bioavailability C. Class 3 B. bioequivalence D. Class 4 C. relative bioavailability E. Class 5 D. absolute bioavailability 24. Enteric coating used to: E. therapeutic equivalence I. mask the taste or odor of a drug 27. Parameters used to assess bioavailability/ II. Minimize irritation of gastric mucosa by the biotaquivalence using plasma drug drug concentration III. Protect the drug from moisture, light, air A. tmax, Cmax IV. Prevent inactivation or degradation of the B. tmax, Cmax, AUC drug in the stomach C. tmax, Emax V. delay the release of the drug until the dosage from the reaches the small intestine, D. t, Du where the condition for absorption may be optimal E. t,Du dDu /dt A. I & II 28.Drugs given by this route of administration are considered to be 100% bioavailable B. II & IV A. Oral C. V only B. Sublingual D. II, IV & V C. Intravenous E. I to V D. Subcutaneous 25. This is an indication of the lipid solubility of a drug and its likelihood of being transported E. intramuscular across membrane. 29. Which of the following is NOT an A. polymorphism extended-release drug product? B. permeability A. sustained release capsule C. pH B. enteric-coated tablet D. pKa C. slow-release tablet D. prolonged-action drug product E. repeat-action tablet 33. Pharmaceutical Equivalents are drug products that have the same 30. This term is applied to a regulatory approval process in which an application is I. active pharmaceutical ingredients (API) approved based on experience of equivalence of a generic drug bioequivalence/in vivo II. Chemical form of the API equivalence testing. III. Dosage form A. dossier IV. Dosage strength B. abbreviated new drug application (ANDA) V. route of administration C. in vivo-in vitro correlation (IVIVC) D. biowaiver VI. Standards of identity, strength, quality and E. e. clinical trials 31. This refers to the trade name of the drug purity product which is privately qwned by the A.I, II manufacturer or distributor and is used to distinguish is the specific drug product from B.II, III, IV those of competitors. C.I, II, III A. generic name D.I to V B. chemical name E. I to VI C. brand name 34. This reference identifies drug products D. market name approved on the basis of safety and effectiveness by the US FDA and contains E. INN therapeutic equivalence evaluation for 32. In the generalized plasma level time curve approved multisource prescription drug shown below, which letter corresponds to the products intensity of action? A. USP/NF B. Orange book C. PNDF D. Essential Drug list In C E. International pharmacopeia CORRECT ANSWER: B. Orange Book CORRECT ANSWER: 35. Which of the following methods is used to determine AUC? C. a. feathering d. analysis of variance (ANOVA) b. back-extrapolation e. two one sided B. B test C. C I c. trapezoidal rule D.D 36. Pharmaceutical alternatives are products that have the same E.E I. active pharmaceutical ingredients (API) 37. It refers to the finished dosage form that contains the active drug ingredient generally, II. chemical form of the API but not necessarily in association with inactive ingredients III. dosage form A. formulation IV. dosage strength B. therapeutic moiety V. route of administration C. drug product VI. standards of identity, strength, quality and purity D. Drug delivery system A.I only E. reference listed drug B.III, IV, V 39. This must be filed by generic drug manufacture for approval to market a generic C.I, III, IV drug product D. I, V A. abbreviated new drug application (ANDA) E. I to IV B. new drug application (NDA) 37.It refers to the unfinished dosage form that contains the active drug ingrdient ,generally C. investigational new drug application ,but not necessarily ,in association with active (INDA) ingredients. D. biowaiver A. formulation E. BA/BE study B. therapeutic moiety 40. The processes of drug metabolism and C. drug product excretion constitute D. drug delivery system A. deposition E. reference drug list B. elimination 38.In the given plasma-level time curve below C. accumulation ,identify the letter that corresponds to the onset of action. D. biotransformation A. A E. clearance 41. It is the term used to describe the B. maximum plasma drug concentration accidental fast release of drug from a (Cmax) sustained release dosage form C. bioavailability A. liberation D. bioequivalence B. steady state E. therapeutic equivalence C. dose dumping D. flip flop model 45. Therapeutic equivalence is established E. first pass effect when the drug prosuct being compared are: 42. This is the rate and extent to which the I. approved as safe and effective active pharmaceutical ingredient or active moiety is absorbed from a drug product and II. pharmaceutical equivalents or alternatives becomes available at the site of action III. bioequivalent A. area under the curve (AUC) IV. manufactured in compliance to cGMP B. maximum plasma drug concentration IV. adequately labeled (Cmax) A.I only C. bioavailability B.III only D. bioequivalence C.I, II, III E. therapeutic equivalence D. I to IV 43. This is a measure of the quantity of the drug in the body and ref;ects the total amount E.I to V of active drug that reaches the systemic circulation. 46.To establish bioequivalence the calculated confidence interval should fail within the A. area under the curve (AUC) usually prescribed limit of ___ for the ratio of the product averages B. maximum plasma drug concentration (Cmax) A.50-100% C. bioavailability B.90-110% D. bioequivalence C.80-120% E. therapeutic equivalence D. 95-100% 44. This established when pharmaceutical E. 80-125% equivalents or alternatives display comparable bioavailabilities when studied under similar 47. Generally, two drug product formulations experimental conditions whose rate and extent of absorption differ by __% or less are considered bioequivalent. A. area under the curve (AUC) A. 50 D. 20 B. Recirculation E. Residence B.40 E. 10 C. Reactivation C. 30 52. It is the study of how the physicochemical properties of a drug, dosage forms and route s 48. For drugs that have very poor aqueous of administration affect the rate and extent of solubility the rate limiting step on drug drug absorption. bioavailability is: A. LADMER system D. Biopharmaceutics A. disintegration B. Pharmaceutics E. Pharmacokinetics B. dissolution C. Physical Pharmacy C. permeation 53. This is actual site of pharmacologic action D. gastric emptying of drugs in the body E. disaggregation A. compartment D. cytosol 49. Which of the following is NOT true? B. biophase E. plasma A. The amorphous form of the drug C. cell membrane generally dissolves faster 54. Which of the following absorption B. Polymorphs have the same chemical mechanism operate along concentration structures and physical properties gradient? C. Some excipients are intentionally I. passive diffusion II. Active transport added to delay drug absorption III. facilitiated diffusion IV, vesicular transport D. smaller particles size increases dissolution rate A.I only E. a basic drug is more soluble in an B.III only acidic medium C.I and III 50. The tmax of a drug refers to its time: D. II and IV A. of the fastest dissolution E.I to IV B. to reach maximum drug concentration 55. This is the fraction of an administered C. of highest solubility dose of a drug that reaches the systemic circulation in the unchanged form. D. to reach maximum toxic concentration A. bioavailable dose D. dumped dose E. of maximum effectiveness B. loading dose E. oral dose 51. In the LADMER system, R stands for? C. maintenance dose A. Reabsorption D. Response 56. a 125 mg/mL drug suspension decompose D. fluid mosaic with a zero order rate constant of 0.5 mg/mL/hr. What is the concentration of the E. unit membrane active drug remaining after 3 days 60. This refers to the ability of a drug to exixt A. 125 D. 89 in more than one crystalline form. B. 123.5 E. 62 A. amphoterism C. 100 B. crystallization 57.In the generalized plasma level –time C. polymorphism curve given below ,what corresponds to the D. ionization broken line E. E. complexation A. Maximum drug concentration 61. Dissolution rate differ for hydrated and (Cmax) anhydrous forms of a drug however, the most B. Onset of action usual situation is: C. Minimum effective A. the anhydrous form dissolves faster concentration(MEC) B. the hydrated form dissolves faster D. Duration of action C. the anhydrous and hydrated forms E. Intensity have equal dissolution rates 58. Example of a targeted drug delivery D. the hydrated form has no effect on system dissolution A. osmotic pumps E. the anhydrous form has no effect on dissolution B. enteric-coated tablets 62. Equivalence are not necessary for which C. liposomes of the following products D. cyclodextrins I. Parenteral aqueous solution E. implants II. Pharmaceutically equivalent oral solutions 59. This concept views the cell membrane as III. pharmaceutically equivalents topical being composed of a non-rigid lipid matrix with solutions which are associated relatively mobile protein masses that penetrate wholly or partially IV. products containing drugs with narrow through the lipid layer therapeutic indices A. lipid bilayer model A. I only B. phospolipid matrix theory B. IV only C. lipoprotein compartment C. II and III D. I to III D. buccal E. I to IV E. topical 63. Which of the following transport 67. Which of the following is NOT an enteral mechanism does not require a drug to be in route of drug administration aqueous solution in order to be absorbed? A. sublingual A. passive diffusion B. buccal B. convective transport C. rectal C. carrier mediated transport D. Peroral D. ion transport E. None of the previous choices E. vesicular transport 68. Which of the following compounds may be 64. These are added to a formulation to absorbed via convective transport? provide certain functional properties to the drug and dosage form A. Vitamin B12 A. prodrugs B. inorganic and organic electrolytes with molecular weights up to 400 B. xenobiotics C. most weal organic acids and bases C. probiotics D. fats D. excipients E. quaternary ammonium compounds E. active ingredients 69. Determine the half-life of an 65. The LADMER system is essential in the : antihypertensive drug if it appears to be eliminated from the body at a rate constant of A. development of dosage forms 0.07 hour. Assume first order kinetics occurs. B. determinations of pharmacokinetic A. 12 parameters B. 9.9 C. evaluation of bioavailability C. 7 D. adjustment of dosage regimen D. 4 E. all of the given choices E. 1.5 66. This is the most common and popular route of the drug administration 70. Which of the following statements is NOT true? A. oral A. a cell membrane is a semi permeable B. parenteral structure composed of lipids and proteins C. rectal B. Drugs bound to protein do not easily 74. Which of the following is NOT a cross cell membranes characteristic of active transport? C. Ionic or polar, water- soluble drugs A. drug moves along concentration cross cell membrane more easily than do nonpolar, lipid soluble drugs. B. process requires expenditure of energy D. low molecular weights drugs diffuse across cell membrane more easily C. requires a carrier than do high molecular weight drugs D. saturable at high drug concentration E. drugs may transported by passive E. process is subject to competition diffusion, carrier-mediated, paracellular or vesicular transports 75. These are addition compounds of drugs and organic solvents 71. Most drugs are: A. hydrates A. strong electrolytes B. solvates B. non electrolytes C. polymorphs C. weak acids D. clathrates D. weak bases E. chelates E. C and D 76. Which of the following statements is false? 72. Which of the following is/are forms of vesicular transport that differ by the type of A. In general, salts of electrolytes material ingested? dissolve faster than the free acids or bases A. I only B. the most stable polymorphs has the B. III only lowest dissolution rate C. I and II C. Increasing amounts of binders in D. III and IV grabukes and tablets prolong dissolution time. E. I to IV D. Increasing amounts of lubricants 73. The drug is injected into the spinal fluid shortens dissolution time A. intraarticular E. particle size reduction is not a universal answer to all drugs of low B. epidural solubility C. Intracranial 77. The enormous surface are of the gastrointestinal tract is due to presence of: D. Intrathecal A. enzymes E. intrasynovial B. microvilli E. transdermal C. parietal cells 81. Type of parenteral administration in which the drug is injected slowly into the plasma at a D. tight junctions constant or zero-order rate E. gastric pits A. IV push 78. In oral drug administration, the drug is B. IV bolus swallowed undergoes absorption from the gastrointestinal tract through the mesenteric C. IV infusion circulation to the ___ into the liver and then to the systemic circulation D. IM A. hepatic portal vein E. SQ B. biliary duct 82. The pharmacological effect of a drug depends on the percentage of receptors C. aorta occupied D. jugular vein A. Lock and key hypothesis E. superior vena cava B. Hypothesis of paton 79. A condition in which the rate of drug C. Hypotheses of Ariens and Stephenson leaving the body is equal to the rate of drug entering the body. D. Hypothesis of clark A. double-peak phenomenon E. Occupation theory B. flip-flop model 83. the drug molecules is bound to the surface of the skin or mucosa by ion-binding, C. first-pass effect hydrogen-binding or van der waals forces: D. steady state a. absorption E. therapeutic window b. penetration 80. The route of drug administration that is c. Adsorption preffered when rapid absorption is essential, when patients are inconscious or unable to d.Permeation accept medications by mouth or when drugs e. leaching are destroted, inactivated or poorly absorbed in the GIT. 84. It describes the diffusion-controlled rate of drug dissolution A. peroral A. Henderson-hasselbach equation B. sublingual B. fick’s law of diffusion C. parenteral C. Michaelis-menten equation D. Rectal D. Noyes-whitney equation 88. This is the time from drug administration to reach the minimum effective concentration E. Van slyke’s equation (MEC) 85. which of the following parameters will a. onset d. therapeutic window determine the degree of drug ionizations? b. intensity e.area under the curve(AUC) I. lipid/ water coefficient of the drug c. duration of action II. pH at the absorption rate 90. This refers to the drug concentration range III. pKa of the drug between the minimum effective concentration (MEC) and the minimum toxic concentration A. I only (MTC) B. I and II a. onset C. I and III b. intensity D. II and III c. duration of action E. I,II and III d. therapeutic window 86. What is the minimum percent of drug that e. area under curve must be in the nonionized form at the small intestine in order to be absorbed via passive 91. This describes the relationship between diffusion the ionized and the nonionized forms of a drug as a function of pH and pKa. a. 0.1% to 1% d. 50% to 60% a. Law of Multiple proportions b. 1 to 5% e. 80% to 90% b. Nernst Distribution Law c. 10 to 20% c. Henderson-Hasselbach equation 87. The partition coefficient is a/an: d. common-ion effect A. in vitro guide to the absorption potential of a drug e. partition coefficient B. measure of the relative affinity of a 92. Which of the following is a common site drug for two immiscible phases for IM injection? C. indicator for storage of drugs in fat a. gluteus medius D. parameter of the relative rate of b. thigh e. ebdomen partitioning from one phase into another c. Gastrocnemius E. all of the given choices d. gluteus maximus e. abdomen 93. It refers to the time for which the drug 98. Cmax represents the maximum drug concentration remains above the minimum concentration obtained after oral effective concentration (MEC) administration of a drug in the: a. duration of action d. Cmax A. plasma D.feces b. intensity e. onset B. urine E. sweat c. tmax C. saliva 94. Which of the following oil phases is most 99. This is an entity which can be described commonly used in partition coefficient by a definite volume and a concentration of determination? drug contained in that volume a. chloroform d. mineral oil A. biophase D. compartment b. cyclohexane e. octanol B. bulk phase E. depot phase c. isopropyl myristate C. diffusion layer 95. Maximum volume to be injected via the 100. Order reaction in which the concentration intramuscular route: of a drug is decreasing at a rate that is proportional to the concentration of the drug a. 0.5 mL d. 5 mL remaining: b. 1 mL e. 10 mL A. zero D. third c. 2 mL B. first E. fourth 96. This is the dose used in initiating therapy C. second so as to yield therapeutic concentration which will result in clinical effectiveness 101. Facilitated diffusion is similar to active transport since it: A. daily dose D. loading dose A. operates against concentration B. First dose E. effective dose gradient C. prophylactic dose B. utilizes energy in the form of ATP 97. This is the dose required to maintain the C. is carrier mediated clinical effectiveness or therapeutic concentration according to the dosage D. None of the choices regimen. E. all of the given choices A. therapeutic dose D. priming dose 102. Decreased particle size results to: B. maintenance dose E. effective dose A. increased particle surface area C. steady-state dose B. enhanced water penetration into particles C. increased dissolution rate D. none of the choices A. zero-order kinetics E. all of the above B. first-order kinetics 103. When drug is half ionized and half C. half-life nonionized at a certain pH, its pKa is: D. rate-limiting step A. greater than pH E. clearance B. less than pH 107. These are inactive substances that must C. equal to pH be biotransformed in the body to metabolites that have pharmacologic activity D. of no value A. xenobiotics E. constant B. lead compounds 104. This is obtained when the drug product is administered at the site where the C. prodrugs pharmacological response is desired and when the drug released from the products D. therapeutic moieties acts by adsorption to the skin or mucosa, but E. orphan drugs does not enter the systemic blood circulations 108. Reabsorption of drugs can occur in the A. systemic effect I. kidneys B. local effect II. Liver C. therapeutic response III. Small intestines D. Biological response A. I only E. dermal effect B. II only 105. This is obtained when the drug released the drug product enters the bloodstream and C. III only is distributed within the body regardless of the site and route of administration D. I and II A. systemic effect E. I and III B. local effect 109. The form of the drug that is absorbed: C. therapeutic effect I. nonionized D. biological response II. Ionized E. dermal effect III. lipid-soluble 106. This is the process with the slowest rate IV. Water-soluble constant in a system of simultaneous kinetic a. I only processes. b. II only A. independent of the concentration gradient c. I and III B. inversely proportional to the surface d. II and IV area of the membrane e. I to IV C. inversely proportional to the membrane thickness 110. What is the % of ionized species of a weak acid with a pKa of 4.2 in a urine pH of D. inversely proportional to the partition 6.2? coefficient of the drug a. 0.1 E. independent of the diffusion coefficient of the drug b. 1 115. Highly lipid soluble drugs are c. 10 predominantly distributed in which of the d. 90 following tissues? e. 99 A. bone 111. Which of the following is devoid of B. adipose clotting proteins? C. muscle A. blood B. plasma D. hepatic C. serum E. renal D. both B and C 116. These are substances that have no pharmacological properties of their own in the E. all of the given choices concentration used, but which can improve the penetration of drugs into the skin or 112. Drug entering the body does not instantly mucosa. distribute between the blood and those other body fluids or tissues which it eventually A. humectants reaches B. emollients A. open one-compartment model C. sorption promoters B. open two-compartment model D. wetting agents C. multi-million compartment model E. solubilizers D. central compartment 117. Absorption mechanism in which drug E. peripheral compartment molecules dissolved in aqueous medium at the absorption site move along with the 113. According to the Fick’s Law, the rate of solvent through membrane pores: diffusion of a drug is: A. passive diffusion B. active transport 121. Which of the following is the correct rank order (from the most bioavailable to the least) C. facilitated diffusion for the given conventional oral formulations? D. convective transport A. coated tablet> uncoated tablet> capsule> suspension> solution E. ion-pair transport B. solution> suspension> capsule> 118. Which of the following absorption coated tablet> uncoated tablet mechanisms operate(s) against concentration gradient? C. suspension> solution> uncoated tablet> coated tablet> capsule I. passive diffusion D. solution> suspension> capsule> II. Facilitated diffusion uncoated tablet> coated tablet III. Active transport E. capsule> uncoated tablet> coated A. I only tablet> solution> suspension B. II only 122. Excipients are added to product formulations to: C. III only A. facilitate preparation D. I and II B. improve patient acceptability of the E. II and III product 119. Rate constants in pharmacokinetics are C. improve functioning of the dosage usually: form as a drug delivery system A. zero-order D. all of the choices B. first-order E. none of the choices C. second-order 123. An aqueous phase (pH 7.4 buffer) containing a drug, was shaken with an oil D. third-order phase (octanol) and the mixture was then left E. fourth-order to reach equilibrium. The two phases were the separated and the concentration of the drug in 120. Cyancobalamin is a classical example of each phase was measured. The resulting a drug that is absorbed via: values were as follows: C octanol = 18; C buffer = 2. Based from the results, calculate A. convective transport the partition coefficient of the drug. B. facilitated diffusion A. 36 C. vesicular transport B. 20 D. passive diffusion C. 16 E. ion-pair transport D. 9 E. 0.11 C. solubilization 124. These are drugs in which the D. all of the choices pharmacological action is not directly dependent on the chemical structure of the E. none of the choices drug. 128. Which of the following is/are the effect/s A. structural nonspecific drugs of food on the bioavailability of a drug from a drug product? B. structural specific drugs A. delay in gastric emptying C. drug-receptor complexes B. stimulation of bile flow D. ligands C. physical or chemical interaction of the E. substrates meal with the drug product or drug substance 125. If the volume of distribution of a drug in an adult is approximately 5L, it means that the D. a change in the pH of the GIT drug is confines to the: E. all of the given choices A. circulatory system 129. In passive diffusion, the term passive B. extracellular fluid pertains to what characteristic of this absorption mechanism? C. intracellular fluid A. moves along concentration gradient D. whole body fluid B. a carrier mediated process E. deep tissues C. does not require the expenditure of 126. Surfactants are used: in dosage forms energy as: D. is subject to competition A. emulsifying agents E. has saturation point B. solubilizing agents 130. This is the loss of drug from the central C. suspending agnets compartment due to transfer into other compartments and/or elimination D. wetting agents A. absorption E. all of the given choices B. distribution 127. Which of the following is/are technique/s used to increase the aqueous solubility of C. penetration poorly water-soluble drugs? D. disposition A. cosolvency E. permeation B. complex formation 131. Which of the following is/are the D. III to V equation/s of a first-order reaction? E. II to V I. C= -k0 t + C0 134. Which of the following processes occurs II. In C= -kt + In C0 mostly in the proximal convoluted tubule (PCT)? III. log C = -(k/2.3)t + log C0 A. glomerular infiltration IV. C = C0e –kt B. tubular secretion A. I only C. tubular reabsorption B. II only D. both B and C C. III only E. all of the given choices D. II to IV 135. In order to excrete amphetamine more E. I to IV quickly in the urine, which of the following may be used intravenously? 132. The half-life of a given drug is 6 hours. How many half-lives have passed 24 hours A. urinary acidifier after administration? B. urinary alkanizer A. 24 C. inulin B. 12 D. creatinine C. 10 E. all of the choices D. 6 136. If the AUC for an oral dose of a drug E. 4 administered by tablet is 4.5 mcg/mL/hr, and the intravenous dose is 11.2 mcg/mL/hr, 133. Which of the following is NOT an calculate the absolute bioavailability (in %) of extravascular route of drug administration? the oral dose of the drug. I. oral A. 2.5 II. rectal B. 10 III. intramuscular C. 15 IV. subcutaneous D. 40 V. intravenous E. 62 A. I only 137. The normal glomerular filtration rate B. V only (GFR) is: C. I and II A. 125-130 mL/min B. 90-100 mL/min B. 56.9% C. 60-90 mL/min C. 42.2% D. 30-59 mL/min D. 23.6% E. ,15 mL/min 141. If the volume of distribution exceeds the body weight, it is assumed that the drug is: A. stored in body fat 138. A patient received a single intravenous dose of 300mg of a drug substance that B. bound to body tissues produced an immediate blood concentration of 8.2 mcg/mL. Calculate the volume of C. distributed to deep tissues in distribution in liters(L). peripheral compartments A. 36.6 D. A and B B. 27.3 E. all of the above C. 20.5 142. If the half-life for decomposition of a drug is 12 hours, compute for the first-order rate D. 10.6 constant. E. 8.7 A. 0.693/hr 139. The peripheral compartment is B. 0.510/hr subdivided into: C. 0.267/hr A. central compartment D. 0.058/hr B. shallow compartment E. 0.012/hr C. deep compartment 143. Vegetables and fruits, and diets rich in D. both A and B carbohydrates result to a/an: E. both B and C A. decrease in urinary pH 140. The bioavailability of a new B. increase in urinary pH investigational drug was studied in 24 volunteers. Each volunteer received either a C. increase GFR single oral tablet (200mg), 5ml of a pure D. decrease GFR aqueous solution (200mg) or a single IV bolus injection (50mg). The average AUC values are E. none of the choices given below. From these data, calculate the absolute bioavailability of the drug. 144. The central compartment refers to the: 104% A. body fluids or tissues into which the drug distributes slowly A. 59.2% B. compartment that is not accessible by blood sampling 148. This concept in pharmacokinetics is a C. body fluids or tissues which are in hypothetical structure which can be used to equilibrium with the circulatory system characterize with reproducibility, the behavior and the fate of a drug in biological systems D. both A and B when given by a certain route of administration and in a particular dosage form. E. both B and C A. biophase 145. The differences in bioavailabilities of drug products may be due to: B. compartment A. physiological factors C. model B. drug factors D. order C. dosage from design E. rate constant D. both B and C 149. If the bioavailability of digoxin in a 0.25-mg tablet is 0.60 compared to the E. all of the given choices bioavailability of 0.75 in a digoxin elixir 146. Which of the following is/are eliminated in (0.05mg/mL), calculate the dose (in mL) of the the body solely by filtration? elixir equivalent to the tablet. A. inulin A. 0.0375 B. creatinine B. 0.15 C. electrolytes C. 0.5 D. both A and B D. 3 E. both B and C E. 4 147. A solution of a drug was freshly prepared 150. The concentration of a drug remaining at a concentration of 300mg/ml. After 30 days after 180 min was 5mg/dL from an initial conc. at 25°C, the drug concentration in the solution of 60mg/dL. Compute for the first-order rate was 75mg/mL. Assuming first-order kinetics, constant. when will the drug decline to one-half of the A. 0.001/min original concentration? B. 0.02/min A. 0.046 day C. 0.0138/min B. 0.5 day D. 0.693/min C. 7 days E. 0.05/min D. 10 days E. 15 days 151. In IV infusion, it is essential to administer 155. It refers to the net transfer of a drug from the dose in order to immediately reach the the circulating fluids of the body to various steady state. tissues and organs. A. Loading dose A. Absorption B. Distribution B. Maintainance dose C. Metabolism C. Titered dose D. Excretion D. Priming dose E. NOTA E. Choices A and D 156. This refers to the extent of fraction of 152. This is the dose used in initiating therapy drug absorbed upon extravascular so as to yield therapeutic concentration which administration in comparison to the dose size will result in clinical effectiveness. administered. A. Loading dose A. Relative bioavailabilty B. Priming dose B. Absolute Bioavailability C. Initial dose C. Pharmacokinetics D. Choices A,B or C D. Biopharmaceutics E. NOTA E. NOTA 153. Passive diffusion follows 157. This method to estimate the area under the curve is used if no curve fitting has been A. Noyes Whitney done for a set of blood level curve is not B. Graham’s smooth if no pharmacokinetic data have been determined. C. Fick’s A. Counting rule D. Hess B. Weighing rule E. NOTA C. Trapezoidal rule 154. Cyanocobalamine can be absorbed through this transport mechanism. D. Jelliffe Rule A. Passive Diffusion E. Crock’s Rule B. Convective 158. These processes are collectively referred to as elimination. C. Active A. Absorption D. Facilitated B. Metabolism E. Ion pair C. Excretion D. Choices A and B C. Biotrans E. Choices B and C D. Biophase 159. This is the sum of all body regions in E. Microsomes which the drug concentration is in instantaneous equlibrium with that in blood or 163. This refers to the hypothetical volume of plasma. distribution in mL of the unmetabolized drug which is cleared per unit of time by any A. Central Compartment pathway of drug removal B. Peripheral Compartment A. Volume of Distribution C. Compartment B. Clearance D. Tissues C. Concentration gradient E. System D. Half-life 160. This type of intravenous administration E. Absorption can be considered as multiple dosing with infinitely small dosing intervals. 164. Albumin concentration is reduced in newborns and infants.This may result in A. IV bolus ______volume of distribution and______in free drug concentration in plasma B. IV infusion A. Increased,decreased C. IV Bolus(Multiple dose) B. Decreased,increased D. IV push C. Increased,increased E. NOTA D. Decreased,decreased 161. These processes are collectively called disposition E. NOTA A. Distribution 165. Half-life depends on B. Metabolism A. Volume of distribution C. Excretion B. Clearance D. Choices A and B C. Absorption rate E. AOTA D. Choices A and B 162. This refers to the anatomical location of E. Choices B and C the receptors for a drug. 166. In clinical terms ,it is defined as the A. Enzymes millimeters of blood cleared of drug per minute B. Proenzyme A. Absorption B. Half-life 170. This is a term used to describe the achievement of sustained drug concentration C. Volume of distribution by simply increasing the dose size or by accidental fast release of drug from a D. Clearance sustained release dosage form E. NOTA A. Dose Curve 167. The enzyme capacity in newborns and B. Accumulation infants is reduced.Hence,drugs being metabolized exhibit usually _____elimination C. Dose Dumping half-life and_____clearance. D. Dose Dependency A. Increased,decreased E. Dose Attrition B. Decreased,increased 171. This is the first step in oral absorption C. Increased,increased process D. Decreased,decreased A. Drug enters the systemic circulation E. NOTA B. Drug dissolved in the intestinal fluid 168. In intravenous multiple dose C. Drug crosses the epithelial tissues of administraton ,the longer the elimination half- the GI tract life and the shorter the dosing interval. D. Drug crosses the hepatoportal system A. the lower will be the accumulation E. Drug enters the inferior vena cava B. the faster will be the accumulation 172. A drug is considered completely when C. the slower will be the accumulation absorbed when D. the higher will be the accumulation A. Drug enters the systemic circulation E. NOTA B. Drug dissolved in the intestinal fluid 169. This can be determined from C. Drug crosses the epithelial tissues of experiments in which a subject is given the the GI tract same dose bolus IV dose and an oral dose and the ratio of the AUC of the two is D. Drug crosses the hepatoportal system calculated E. Drug enters the inferior vena cava A. Fraction dissolved 173.This is a phenomenon in which the drug B. Fraction expelled is completely subjected to liver metabolism C. Fraction absorbed A. Pre-systemic metabolism D. Fraction excreted B. First pass effect E. Fraction distributed C. Enterohepatic recycling D. Choices A and B B. Adverse effects E. Choices B and C C. Side effects 174. This refers to the time in hours necessary D. Therapeutic failure to reduce the drug concentration in the blood, plasma , or serum to one-half equilibrium is E. Narrow therapeutic index reached 178. Why do pharmacokineticists measure A. Half-life drug levels? B. Clearance A. Design of a dosage regimen C. Elimination B. Maintain drug at optimum drug levels D. Hepatic Clearance C. Confirm patient compliance E. Gastric Emptying D. AOTA 175. This is used to describe the process of E. NOTA taking drug concentrations ,basic 179. Drug levels are measured at this time ,pharmacokinetic principles , and the person’s period to assess the current therapy clinical response and combining them to optimize drug therapy for the patient A. Minimum therapeutic concentration A. Clinical Pharmacokinetics B. Maxinum toxic cocentration B. Therapeutic Drug Monitoring C. Steady State Level C. Applied Pharmacokinetics D. AOTA D. AOTA E. NOTA E. NOTA 180. This is the final elimination of a drug from the body’s systemic circulation via the kidney 176. At steady state ,the longer the elimination into urine ,via bile and saliva into the half-life and the shorter the dosing interval, intestines,and into feces,via sweat,skin,and A. the less will be the fluctuation milk. B. the higher will be the fluctuation A. Enterohepatic recycling C. the more will be the fluctuation B. Metabolism D. Choices B and C C. Excretion E. NOTA D. Urination 177. Blood level determinations are done E. Clearance when a medication has a 181. These are usually measured if a drug is A. Toxicity given by extravascular administration or intermittent infusion and it demonstrates a 185. Drug concentrations are obtained by significant difference in concentration before end after dosing. A. Venipuncture of the venous blood A. Peak concentration B. Venous of arterial blood B. Trough concentration C. Venipuncture of jugular blood C. Steady State concentration D. Choices A and B D. Choices A and B E. Choices B and C E. AOTA 186. The larger amount of total body fluid and the very small amount of fat tissue in infants 182. This is the increase in enzyme content or make it likely that the volume of distribution of rate of enzymatic processes resulting in faster hydrophilic compounds is_____ and that of metabolism of a compound. lipophilic ones is_____ A. Enzyme Restriction A. Increased, decreased B. Enzyme Inhibition B. Decreased, increased C. Enzyme Imbibition C. Increased, increased D. Enzyme Induction D. Decreased, decreased E. Enzyme Coagulation E. NOTA 183. The peak for an intravenous bolus dose 187. If a drug stimulates its own metabolism.it would be obtained. is called A. Immediately after the dose is given A. Oxidation B. Right after the infusion stops B. Reduction C. After the distribution C. Auto oxidation D. After the elimination phase D. Auto induction E. NOTA E. Enzyme Inhibition 184. The peak concentration following an IV 188. This refers to a graphical method for infusion of a drug usually occur separation of exponents such as separating the absorption rate constant from the A. Immediately after the dose is given elimination rate constant. B. Right after the dose stops A. Residual Method C. After the distribution phase B. Feathering D. After the elimination phase C. Interpolation E. NOTA D. Extrapolation D. Minimum therapeutic concentration E. Choices A and B E. Maximum therapeutic concentration 189. This is the most frequently used assay 193. This refers to a change of one or more of method for therapeutic drug monitoring. the pharmacokinetic parameters during absorption,metabolism and excretion by A. Radioimmunoassay saturation or overloading of processes due to increase dose size. B. Gas Chromatography A. Saturation kinetics C. Microbiological assay B. Non-linear kinetics D. Enzyme multiplied immunoassay C. Linear kinetics E. NOTA D. First pass effect 190. It is the sum of all chemical reactions for biotransformation of endogenous and E. Choices A and B exogenous substances which take place in the living cell 194. This is observed upon topical or rectal route of administration where the absorption is A. Absorption slower than the elimination. B. Elimination A. Flip-Stock Model C. Metabolism B. Flip-Top Model D. Excretion C. Flip-Flop Model E. Clearance D. Flip-Stop Model 191. It can be determined using a person’s E. Flip-Stoop Model weight in kilograms and height in centimeterss 195. It is a measure of the rate and extent of A. Creatinine clearance drug absorption B. Lean Body weight A. Cmax C. Average Body weight B. AUC D. Body Surface Area C. BA E. NOTA D. F 192. It is the lowest concentration of a drug E. Ka that arrests or inhibits the growth of a bacteria 196. Determinations which can directly the A. Maximum inhibitory concentration rate and extent of absorption B. Minimum inhibitory concentration A. F C. Minimum effective concentration B. Ka 200. This term compares the extent of absorption of a test product (i.e.,generic)to a C. AUC standard or reference product,which is often an oral solution or an immediate-release tablet D. Choices A and B ,but not an IV product. E. Choices B and C A. Absolute Bioavailability 197. The FDA lists these products if they B. Relative Bioavailability pharmaceutical equivalents that are bioequivalent C. Intermediate Bioavailability A. Pharmaceutical Equivalents D. AOTA B. Pharmaceutical alternatives E. NOTA C. Bioequivalent drug products 201. This principle states that the concentration of the drug remainingin the D. Therapeutic equivalents body at any time is added to the concentration E. Ion pair remaining from the previous dose 198. This transport mechanism is formed A. Multiple dosing through the complex of an organic anion of a B. IV Bolus substance with a cation of medium or membrane C. Superposition A. Passive diffusion D. Exponentiation B. Convective transport E. Potentiation C. Active 202. This measure of creatinine can be expressed directly by measuring urine output D. Facilitated for 24hours and dividing this volume by E. Ion pair measurement of serum creatinine drawn at the midpoint of the 24-hour collection period 199. The transport mechanism happens against concentration and electrochemical A. Hepatic clearance potential B. Nephrotic clearance A. Passive diffusion C. Creatinine clearance B. Convective transport D. Clearance C. Active E. Cockcroft and Gault D. Facilitated 203. This transport mechanism is mediated by E. Ion pair means of carriers under expenditure of energy and along a concentration gradient. A. Passive diffusion B. Convective 207. The primary goal of Phase 1 in drug development C. Active A. Safety of the drug candidate D. Facilitated B. Efficacy of the drug candidate 204. Vitamins A, D, E and K can be transported via the mechanism C. Quality of the drug candidate A. Pinocytosis D. Stability of the drug candidate B. Active E. AOTA C. Passive Diffusion 208. The initial administration of an investigational new drug to humans is usually D. Facilitated accomplished in E. Ion Pair A. Patients 205. This equation allows the determination of B. Healthy subjects the differences in creatinine clearance based on patients’ weight ,age and gender C. Rodents A. Jellife D. Choices A and B B. Cockcroft and Gault E. Choices B and C C. Noyes Whitney 209. It is the only transport mechanism in which the drug or compound does not have to D. Fick’s be in aqueous solution in order to be absorbed E. NOTA A. Endocytosis 206. This is a result of saturation of a metabolic carrier mediated system because B. Passive diffusion the enzyme involved in the metabolic process can no longer C. Active Accept drug resulting in an increase in plasma D. Facilitated drug concentration and possible toxicity E. Ion pair A. Linear pharmacokinetics 210. In the treatment design ,both an active B. Nonlinear pharmacokinetics and a placebo are given to the same subject C. Saturated pharmacokinetics A. Time series design D. Unsaturated pharmacokinetics B. Cohort E. NOTA C. Crossover D. Placebo E. Causal 214. The blood level time curve should have at least hoe many blood level points during 211.If rats were the most sensitive species the absorptive phase? ,the starting dose for human acute dose tolerance study would be________of the A. 2 largest no-observable-effect dose (mg/kg)from the chronic rat toxicity study B. 3 A. One-third C. 4 B. One-sixth D. 5 C. One-eight E. 6 D. One-tenth 218. In phase 1 clinical trial the occurrence of a dose limiting adverse event can be E. One-sixteenth grounds for A. Discontinuing the volunteer 212. If the dogs were the most sensitive species, the starting dose for human acute B. Terminating the study dose tolerance study would be ________of C. Increasing sample size the largest no-observable-effect dose (mg/kg) from the chronic rat toxicity study D. Decreasing sample size A. One-third E. Choices B and D B. One-sixth 219. These are sources of pharmacokinetic variability, EXCEPT C. One-eight A. Saturable first pass metabolism D. One-tenth B. Diurnal variation E. One-sixteenth C. Autoinduction 212. If nonhuman primate were the most sensitive species, the starting dose for human D. Genetic polymorphism acute dose tolerance study would be ________of the largest no-observable-effect E. NOTA dose (mg/kg) from the chronic rat toxicity 220. These studies are the first to include study patients with the disease intended for A. One-third treatment B. One-sixth A. Phase I C. One-eight B. Phase II D. One-tenth C. Phase III E. One-sixteenth D. Phase IV E. NOTA 221. This part of Phase II clinical trial proves D. Mass balance studies whether a drug works in patients E. NOTA A. Phase IIa 225. For the determination of current B. Phase IIb pharmacokinetic parameters from blood level curves, sampling should be continued for at C. Phase IIIc least how many elimination half-lives? D. Phase IVd A. 2 E. NOTA B. 3 222. This part of Phase II clinical trial C. 4 determines the best dose ,dose range, titration, scheme, and dose interval. D. 5 A. Phase IIa E. 6 B. Phase IIb 226. This cultured cell model to predict drug absorption is capable of secreting mucin,the C. Phase IIIc primary agent of the mucous barrier in the intestinal mucosa. D. Phase IVd A. HT-29 E. NOTA B. T84 223. It is an increase in drug effect over time despte constant drug concentrations at the C. Caco-2 effect site,which is manifested by a counterclockwise hysteresis loop of plot of D. PAMPA effect vs.concentraton E. Mast cells A. Tolerance 227.This computer simulation aids in the B. Threshold identification of optimal dosage regimen,evaluation of effective PK/PD models C. Sensitization ,placebo response ,disease progression ,adverse effect development ,and ultimately D. Downregulation ,the expedition of the decision making, E. Side effect regulatory review ,and commercialization of new drug processes. 224. The following are performed in phase II clinical trials, EXCEPT A. Computer-aided clinical trial design A. Reproductive toxicology B. GastroPlus B. Placental transfer C. PK/PD Modelling C. carcinogenicity D. GC-MS E. ELISA 228. This cultured cell model is valuable in B. Phase II predicting the role of p-glycoprotein in transport drugs C. Phase III A. HT-29 D. Phase IV B. T84 E. NOTA C. Caco-2 233.This step is analyzing population pharmacokinetics uses graphical and D. PAMPA statistical techniques to reveal patterns in the data ,identify potential outliers,and provide a E. Mast cells diagnostic tool for confirming assumptions or suggesting corrective action if assumptions 229. This cultured line allows for are not met. characterization of mucosal to serosal and serosal to mucosal transport and can b=e A. Exploratory data analysis used to study transcellular and paracellular transport B. Population pharmacokinetic model analysis A. HT-29 C. Model validation B. T84 D. Compartmental analysis C. Caco-2 E. Abstract D. PAMPA 234.Subcutaneous injection of octreotide E. Mast cells acetate leads to symptomatic control in patients with acromegaly and some gastro- 230. In this method to evaluate the transport entero-pancreatic tumors.However to be fully of drugs ,a small section of intestinal mucosa effective ,a regimen of three times daily is sandwiched between two chambers dosing is warranted.To improve patient containing buffer. convenience and compliance ,octreotide A. Clinical safety acetate has been reformulated into microspheres of a biodegradable polumer. B. Clinical efficacy This warrants C. Clinical outcome A. Slow drug release of octreotide D. Clinical surrogate B. Sustained release of octreotide E. Clinical identity C. Single monthly intragluteal injection 232. For this particular [hase in the drug D. AOTA development ,the drug candidate is tested under conditions and in patients more closely E. NOTA resembling those who would be encountered 235. Intragluteal injection is a form of if the drug were approved A. Intravenous injection A. Phase I B. Subcutaneous injection C. NDA C. Intramuscular injection D. Choices B and C D. Intrathecal injection E. NOTA E. NOTA 239. This refers to the rate and extent to which the active ingredient or active moiety is 236.This is the step in population absorbed from the drug product and becomes pharmacokinetics evaluates the predictive available at the site of action ability of the model by testing it agaisnt a different data set ,either data from another A. Bioequivalence study or data from the study in question which a portion of (e.g.20%)of the total data set has B. Bioavailability been set aside for just such purposes C. Biotransformation A. Exploratory data analysis D. Biotechnology B. Population pharmacokinetic model E. Biosimilar analysis 240. Drug products that contain identical C. Model validation amounts of active ingredient ,i.e.,the same D. Compartmental analysis salt or ester of the same therapeutic moiety ,in identical dosage forms ,but not necessarily E. Abstract containing the same inactive ingredients 237. Other than the intended disease to be A. Therapeutic alternatives treated ,separate studies are usualy conducted for the following conditions during B. Pharmaceutical alternatives Phase III clinical trial to examine the effects on C. Bioequivalent these factors on pharmacokinetics D. Pharmaceutical equivalent A. Renal disease E. Pharmacotherapeutic alternative B. Hepatic disease 241. Drug products that contain identical C. Elderly populations therapeutic moiety or its precursor, but not D. Pediatric populations necessarily in the same amount or dosage form or as the same salt or ester E. AOTA A. Therapeutic alternatives 238. This is the document through which the active ingredient or active moiety is absorbed B. Pharmaceutical alternatives from the drug product and becomes available C. Bioequivalent at the site of action D. Pharmaceutical equivalents A. IND E. Pharmacotherapeutic alternative B. ANDA 242. This drug product category can only be 245.It is a measure of the extent of drug met if the drug products are pharmaceutical absorption equivalents and if they can be expected to have the same clinical effect and safety profile A. Half-life when administered to patients under the B. Volume of Distribution conditions specified in the labeling C. AUC A. Therapeutic equivalents D. Cmax B. Pharmaceutical alternatives E. tmax C. Bioequivalence 246. This method of assessing the D. Pharmaceutical equivalence bioavailabilty of a drug can only be used if E. Pharmacotherapeutic alternative urinary excretion is the main pathway of elimination 243. This refers to the absence of a significant difference in the rate and extent to which the A. Urinary excretion data active ingredient or active moiety in B. Plasma data pharmaceutical equivalents for pharmaceutical alternatives becomes C. Serum data available at the site of action when administered at the same molar dose under D. Half-life similar conditions in an appropriately designed E. Volume of distribution study 247. Gastric emptying depends on the A. Therapeutic equivalence following factors,EXCEPT B. Pharmaceutical alternatives A. Viscosity of the stomach C. Bioequivalence B. pH of the stomach D. Pharmaceutical equivalents C. Volume of liquid intake E. Pharmacotherapeutic alternative D. Disease state 244. Bioavailability and /or bioequivalence are E. pKa of the drug essential for the following situations ,EXCEPT 248. This occurs when absorbed drug passes A. For all new molecular entities directly through the liver before reaching the B. For a new dosage form of a drug systemic circulation after oral administration. C. For a new salt or ester of a drug A. First-pass metabolism D. For a new indication B. Intestinal metabolism E. AOTA C. Hydrolysis of the drug in the stomach D. Transported by p-glycoprotein E. Complexation A. Dialysis 249. This is the usual research design for B. Ultracentrifugation conducting bioavailabilty and bioequivalence studies C. Agar plate test A. two-formulation , two-period ,two- D. AOTA sequence non-replicate crossover E. NOTA design 253. Drug binding to protein can be B. two-formulation, three-period ,three- considered as a sequence non-replicate crossover design A. Reversible process C. two- formulation, two-period ,three- B. Irreversible process sequence non-replicate crossover design C. Linear D. two-formulation ,two-period ,two- D. Nonlinear sequence non-replicate cohort design E. Saturated E. AOTA 254. These are the known importance of drug- 250. This occurs when the drug is protein binding metabolized in the intestine itself or during the A. Buffer passage through the intestinal wall B. Transport A. First-pass metabolism C. Protection B. Intestinal metabolism D. Choices A and B C. Hydrolysis of the drug in the stomach E. Choices B and C D. Transported by p-glycoprotein 255. This physiological importance of drug- E. Complexation protein binding is reflected by its capacity to 251. The main protein fraction blood plasma is maintain a relatively constant concentration of free drug over a long period of time A. Histidine A. Buffer function B. Arginine B. Transport function C. Proline C. Protection function D. Lysine D. Choices A and B E. Albumin E. Choices B and C 252. The extent of protein binding is determined in vitro by the following methods, EXCEPT 256. This physiological importance drug- E. NOTA protein binding is reflected with drugs of low solubility in water 260. Bound drugs cannot be metabolized and are not excreted, therefore A. Buffer function A. Increases urinary excretion of drugs B. Transport function B. Increases elimination half-life of drugs C. Protection function C. Decreases binding of hydrophilic D. Choices A and B drugs E. Choices B and C D. Increases glomerular filtration 257. Free drug concentration ____ of plasma E. AOTA binding, but is ______ on tissue binding 261. Biotransformation converts drug into A. Independent , dependent

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