Bioavailability and Bioequivalence: Pharmacokinetic Methods

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What is the primary concern when the test product has levels substantially below those of the reference product?

Pharmaceutical product development

Variability of the test product

Therapeutic efficacy (correct)

Adequacy of the safety database

What is the primary regulatory concern when the test product generates plasma levels substantially above those of the reference product?

Adequacy of the safety database (correct)

Pharmaceutical product development

Variability of the test product

Therapeutic efficacy

What is the purpose of mapping individual dose–response or concentration–response curves?

To determine the recommended therapeutic dose

To assess the increase in plasma levels and potential additional risk (correct)

To evaluate the variability of the test product

To compare plasma levels of the test and reference products

What is the primary concern when the variability of the test product increases?

Safety and efficacy Signup and view all the answers

What can be used in the absence of individual dose–response or concentration–response curve data?

Population dose–response or concentration–response data Signup and view all the answers

What is the primary purpose of pharmacokinetic measurements in product development?

To assess the release of the drug substance into the systemic circulation Signup and view all the answers

What is the purpose of acquiring population dose–response or concentration–response data over a range of doses?

To demonstrate the increase in plasma levels would not be accompanied by additional risk Signup and view all the answers

What is the recommended study design for assessing bioequivalence between two products?

Crossover study Signup and view all the answers

What is the primary assumption in a crossover study design?

Physiological variables have less interoccasion variability Signup and view all the answers

What is the recommended method for analysis of nonreplicate or replicate studies to establish bioequivalence?

Average bioequivalence Signup and view all the answers

What is the guidance for selecting subjects for in vivo bioequivalence studies?

Subjects should represent the general population, taking into account age, sex, and race Signup and view all the answers

What is the age requirement for subjects recruited for in vivo bioequivalence studies?

18 years of age or older Signup and view all the answers

What is the primary focus of pharmacokinetic measures in establishing BA and BE?

Indicating release of the drug substance into the systemic circulation Signup and view all the answers

What is the primary reason for not measuring the active moiety at the site of action?

It is not possible to access the site of action Signup and view all the answers

What is the relationship between the concentration of the active moiety and its metabolites in the systemic circulation?

Some relationship exists between the efficacy and safety and concentration of the active moiety and its metabolites Signup and view all the answers

What is the order of preference for methods to document BA and BE?

Pharmacokinetic, pharmacodynamic, clinical, and in vitro studies Signup and view all the answers

What is the statutory definition of BA and BE based on?

Rate and extent of absorption of the active ingredient Signup and view all the answers

What is the purpose of using pharmacokinetic measures in establishing BA and BE?

To indicate release of the drug substance into the systemic circulation Signup and view all the answers

Bioavailability and Bioequivalence: Pharmacokinetic Methods

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