FDA, however, does not require that bioequivalence among generic copies of the same brand name drug be demonstrated. As a result, it is a concern whether these generic drugs can be used interchangeably. To address this question, the concepts of population bioequivalence for drug prescribability ...
The current concept for the assessment of bioequivalence (BE) is based on the Fundamental Bioequivalence Assumption that when two formulations of the same drug product or two drug products (e.g., a brand name drug and its generic copy) are equivalent in the rate and the extent of drug absor...
Although the FDA has not modified the bioequivalence guidelines for critical-dose drugs, the Canadian regulatory authority, Health Canada, has narrowed the CI requirement for these drugs to 90% to 110%. For prescribability, the current requirements may be adequate for all drugs, including those ...
Methodology has been proposed for evaluating switchability of two formulations of a drug that encompasses bioequivalence aspects using Dragalin and Fedorov's application of the Kullback- Leibler Divergence (KLD) and a metric developed by the Food and Drug Administration (FDA) as measures of discrepanc...
Food and Drug Administration (FDA) recommends that individual bioequivalence (IBE) be assessed using the method proposed by Hyslop, Hsuan, and Holder to address drug switchability. The FDA suggests that a 2×4 cross-over design be considered for assessment of IBE, while a 2×3 cross-over ...
FDAclinical trialbiologicsdrug developmentThe current concept for the assessment of bioequivalence (BE) is based on the Fundamental Bioequivalence Assumption that when two formulations of the same drug product or two drug products (e.g., a brand name drug and its generic copy) are equivalent in ...
Williams, and the FDA Population/Individual Bioequivalence Working Group. An individual bioequivalence criterion: Regulatory considerations. Statist. Med. in press.Chen, M. L., Patnaik, R., Hauck, W. W., Schuirmann, D. F., Hyslop, T., Williams, R. (2000). An individual bioequivalence ...
FDAclinical trialbiologicsdrug developmentThe current concept for the assessment of bioequivalence (BE) is based on the Fundamental Bioequivalence Assumption that when two formulations of the same drug product or two ...