18 Questions
What is the primary concern when the test product has levels substantially below those of the reference product?
Therapeutic efficacy
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
What is the purpose of mapping individual dose–response or concentration–response curves?
To assess the increase in plasma levels and potential additional risk
What is the primary concern when the variability of the test product increases?
Safety and efficacy
What can be used in the absence of individual dose–response or concentration–response curve data?
Population dose–response or concentration–response data
What is the primary purpose of pharmacokinetic measurements in product development?
To assess the release of the drug substance into the systemic circulation
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
What is the recommended study design for assessing bioequivalence between two products?
Crossover study
What is the primary assumption in a crossover study design?
Physiological variables have less interoccasion variability
What is the recommended method for analysis of nonreplicate or replicate studies to establish bioequivalence?
Average bioequivalence
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
What is the age requirement for subjects recruited for in vivo bioequivalence studies?
18 years of age or older
What is the primary focus of pharmacokinetic measures in establishing BA and BE?
Indicating release of the drug substance into the systemic circulation
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
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
What is the order of preference for methods to document BA and BE?
Pharmacokinetic, pharmacodynamic, clinical, and in vitro studies
What is the statutory definition of BA and BE based on?
Rate and extent of absorption of the active ingredient
What is the purpose of using pharmacokinetic measures in establishing BA and BE?
To indicate release of the drug substance into the systemic circulation
This quiz covers the different methods used to measure product quality bioavailability and establish bioequivalence, including pharmacokinetic, pharmacodynamic, clinical, and in vitro studies. It focuses on pharmacokinetic measures such as AUC and Cmax, which are reflective of systemic exposure. Test your knowledge of these approaches and their applications.
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