Podcast
Questions and Answers
What is the primary concern when the test product has levels substantially below those of the reference product?
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?
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?
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?
What is the primary concern when the variability of the test product increases?
What can be used in the absence of individual dose–response or concentration–response curve data?
What can be used in the absence of individual dose–response or concentration–response curve data?
What is the primary purpose of pharmacokinetic measurements in product development?
What is the primary purpose of pharmacokinetic measurements in product development?
What is the purpose of acquiring population dose–response or concentration–response data over a range of doses?
What is the purpose of acquiring population dose–response or concentration–response data over a range of doses?
What is the recommended study design for assessing bioequivalence between two products?
What is the recommended study design for assessing bioequivalence between two products?
What is the primary assumption in a crossover study design?
What is the primary assumption in a crossover study design?
What is the recommended method for analysis of nonreplicate or replicate studies to establish bioequivalence?
What is the recommended method for analysis of nonreplicate or replicate studies to establish bioequivalence?
What is the guidance for selecting subjects for in vivo bioequivalence studies?
What is the guidance for selecting subjects for in vivo bioequivalence studies?
What is the age requirement for subjects recruited for in vivo bioequivalence studies?
What is the age requirement for subjects recruited for in vivo bioequivalence studies?
What is the primary focus of pharmacokinetic measures in establishing BA and BE?
What is the primary focus of pharmacokinetic measures in establishing BA and BE?
What is the primary reason for not measuring the active moiety at the site of action?
What is the primary reason for not measuring the active moiety at the site of action?
What is the relationship between the concentration of the active moiety and its metabolites in the systemic circulation?
What is the relationship between the concentration of the active moiety and its metabolites in the systemic circulation?
What is the order of preference for methods to document BA and BE?
What is the order of preference for methods to document BA and BE?
What is the statutory definition of BA and BE based on?
What is the statutory definition of BA and BE based on?
What is the purpose of using pharmacokinetic measures in establishing BA and BE?
What is the purpose of using pharmacokinetic measures in establishing BA and BE?
