Kim Pharmaceutics Exam Objectives
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Questions and Answers

What determines the membrane permeability of drug substances?

  • Compound size (correct)
  • Bioavailability
  • Chemical formula
  • Physical appearance

What is the characteristic of amorphous solid forms?

  • Repetition in three-dimensional lattice units
  • Definite melting points
  • Long-range order
  • Random molecular arrangement (correct)

Which type of solid form involves molecules or atoms arranged in repetition in a three-dimensional lattice?

  • Crystalline (correct)
  • Solvates
  • Polymeric
  • Cocrystals

What is the defining characteristic of polymorphism in drug formulation?

<p>Different physical properties despite identical composition (D)</p> Signup and view all the answers

What is a prodrug in relation to drug transformation?

<p>Inactive form that needs activation (B)</p> Signup and view all the answers

Which type of solid form can accommodate other molecules to form salts?

<p>Crystalline (A)</p> Signup and view all the answers

What is the primary function of excipients in drug formulations?

<p>To serve as the vehicle or medium for the active drug substance (D)</p> Signup and view all the answers

Which of the following excipients is commonly used as a thickening agent or to form topical gels?

<p>Carbomer (B)</p> Signup and view all the answers

What was the issue observed with the delavirdine mesylate tablets when exposed to high relative humidity?

<p>The tablets exhibited poor dissolution (D)</p> Signup and view all the answers

Which of the following is a physicochemical property used to test chemical substances?

<p>Both melting point depression and vapor pressure (D)</p> Signup and view all the answers

What is the phenomenon of melting point depression?

<p>The reduction of the melting point of a material with a reduction in its size (B)</p> Signup and view all the answers

Which of the following statements about vapor pressure is true?

<p>It does not depend on the presence of other vapors in the air (A)</p> Signup and view all the answers

What is the definition of a dosage form?

<p>The physical form of a dose of drug (B)</p> Signup and view all the answers

What is required before a new drug can be distributed and used?

<p>Obtaining approval from the FDA after filing a New Drug Application (NDA) (B)</p> Signup and view all the answers

What did the Durham-Humphrey Amendment of 1951 establish?

<p>The distinction between prescription and over-the-counter drugs (C)</p> Signup and view all the answers

Which of the following is NOT one of the major federal enactments related to drug regulation and control?

<p>The Controlled Substances Act of 1970 (B)</p> Signup and view all the answers

What is the purpose of the Investigational New Drug (IND) application?

<p>To initiate clinical trials for a new drug (D)</p> Signup and view all the answers

What is the definition of a dosage regimen?

<p>The frequency at which drug doses are given (C)</p> Signup and view all the answers

What is the main purpose of the Kefauver-Harris Amendments of 1962?

<p>To require proof of both safety and effectiveness for FDA approval (D)</p> Signup and view all the answers

What did the Comprehensive Drug Abuse Prevention and Control Act of 1970 establish?

<p>5 schedules for drugs subject to use (C)</p> Signup and view all the answers

What are some characteristics of a goal drug according to the text?

<p>Optimal duration, convenient administration, no side effects, minimal dosage, minimal dosing frequency (A)</p> Signup and view all the answers

What does cGMP stand for in relation to pharmaceuticals?

<p>Current Good Manufacturing Practice (C)</p> Signup and view all the answers

What does cGMP regulate in the pharmaceutical industry?

<p>Packaging, labeling, and storage of pharmaceuticals (B)</p> Signup and view all the answers

What is the role of USP/NF as mentioned in the text?

<p>Establishing standards for drugs and their ingredients (B)</p> Signup and view all the answers

Which of the following is an advantage of transdermal drug delivery?

<p>All of the above (D)</p> Signup and view all the answers

Which of the following is a disadvantage of transdermal drug delivery?

<p>All of the above (D)</p> Signup and view all the answers

What is the primary reason transdermal drug delivery can improve bioavailability?

<p>It avoids first-pass metabolism in the liver (C)</p> Signup and view all the answers

Which characteristic is most important for a drug to be suitable for traditional transdermal delivery?

<p>Low molecular weight and high lipophilicity (A)</p> Signup and view all the answers

Which of the following is NOT a characteristic of drugs suitable for traditional transdermal delivery?

<p>High molecular weight (B)</p> Signup and view all the answers

What is the primary benefit of the controlled and sustained release profile provided by transdermal drug delivery?

<p>Improved patient compliance (D)</p> Signup and view all the answers

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