22 Questions
Which of the following is NOT a method for assessing bioavailability and bioequivalence?
In vivo clinical trial
What is the primary purpose of a prodrug?
To improve solubility and bioavailability of the active drug
What is the purpose of in vitro dissolution testing in bioequivalence studies?
To replace in vivo bioequivalence studies
Which type of drug products may require additional consideration in bioequivalence studies?
All of the above
What is the primary purpose of bioequivalence studies?
To assess the similarity in bioavailability of different drug products
Which of the following is a factor that influences bioavailability?
All of the above
What is an advantage of extended release products?
Reduction in healthcare cost
What is a characteristic of targeted-release drug products?
They release the drug at or near the intended physiologic site of action
What is an example of an orally disintegrating tablet?
Dispersed in saliva and swallowed with little or no water
What is the primary consideration for designing MR drug products for different routes of administration?
Physiochemical, PD, and PK properties of the drug and the properties of the materials used in the dosage form
What is a characteristic of extended release drug products?
They reduce dosage frequency by at least 2-fold
What is a disadvantage of extended release products?
Dose dumping
Under what conditions can an in vivo BE study of one or more lower strengths of a drug product be waived?
If the drug product is in the same dosage form but different strengths and is proportionally similar in active and inactive ingredients
What is a characteristic of enteric coated tablets?
They are time sensitive or dependent on the environment
What is an example of a type of MR drug product that releases a discrete portion of the drug at a time later than immediately after administration?
Delayed release drug products
How many types of MR oral drug products are described based on drug release characteristics?
20
What is the main difference between controlled release and delayed release drug products?
Controlled release products release the drug promptly after administration, while delayed release products release a discrete portion of the drug at a time later than immediately after administration
What is the purpose of a Positive Formulary?
To list therapeutically equivalent or interchangeable drug products that pharmacists may dispense
What is required for a generic product to be assumed therapeutically equivalent?
It must be approved as safe and effective, be pharmaceutically equivalent, bioequivalent, adequately labeled, and manufactured in compliance with Current Good Manufacturing Practice regulations
What is the name of a type of oral extended-release rate dosage form previously described?
Controlled release
What does 'modified release' refer to in relation to oral drug products?
A type of oral dosage form that alters the timing and/or rate of release of the drug
What is the purpose of an in vivo BE study?
To determine the bioequivalence of a drug product
Study Notes
Methods for Assessing BA and BE
- In vivo measurement of active moiety or moieties in biological fluid (PK study)
- In vivo pharmacodynamic (PD) comparison
- In vivo limited clinical comparison
- In vitro comparison
- Any approach deemed acceptable by the FDA
Factors Influencing BA
- No details provided
Definition of a Prodrug
- A prodrug is a chemically modified drug, usually an inactive form, to improve solubility, increase chemical stability, or increase bioavailability of the active drug by decreasing first-pass metabolism
- After oral administration, the inactive prodrug is converted to the active drug generally by biotransformation or hydrolysis
Statistical Analysis for BE
- No details provided
Plasma Level and Urinary Excretion Parameters to Drug BA
- No details provided
Review Process for NDA and ANDA
- No details provided
BE for Specific Drugs and Drug Products
- Oral solution
- Chewable tablets
- Orally administered drugs intended for local action
- BE of topical drug products for local action
- Inhalation and nasal sprays for local drug action
- Alcohol effects on MR drug products
- Endogenous substances
- Long half-life drugs
- Drug products with high intrasubject variability
- Drug products with complex mixtures as the active ingredients
Waivers of In Vivo BE Studies
- BE studies in vitro dissolution testing may be used in lieu of in vivo BE studies for time-sensitive or environment-dependent products
- Examples: Enteric coated
Types of MR Oral Drug Products
- Targeted-release drug products: release drug at or near the intended physiologic site of action
- Orally disintegrating tablets: disintegrate rapidly in the saliva after oral administration
- Extended release drug products: dosage form releases drug over an extended period of time after administration
- Delayed release drug products: dosage form releases a discrete portion/portions of drugs at a time later than immediately after administration
Advantages of Extended Release Products
- Sustained therapeutic blood levels of the drug
- Improved patient compliance
- Reduction in adverse side effects and improvement in tolerability
- Reduction in healthcare cost
Disadvantages of Extended Release Products
- Dose dumping: release of more than the intended fraction or greater rate
- Less flexibility in accurate dose adjustments
- Less possibility for high dosage
- Increased potential for first-pass clearance
- Poor IVIV correlation
Generic Substitution
- Positive Formulary: lists therapeutically equivalent or interchangeable drug products that pharmacists may dispense
- Negative Formulary: lists drug products that are not therapeutically equivalent, and/or the interchange of which is prohibited
Therapeutic Equivalence
- Therapeutic Equivalence is assumed for a generic product if:
- Approved as safe and effective
- Are pharmaceutically equivalent
- Are bioequivalent
- Adequately labeled
- Manufactured in compliance with Current Good Manufacturing Practice regulations
Test your knowledge of bioequivalence and bioavailability, including methods for assessing BA and BE, regulatory differences, and key concepts like biowaivers and prodrugs. This quiz covers the fundamentals of BA and BE in pharmaceutical development.
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