Current Regulatory Standpoint on Evaluating the Bioequivalence of Different Classes of Generic Drugs - is the Evaluation in the Right Direction?

(E-pub Ahead of Print)

Author(s): Francis Micheal*, Balamurali MM, Mohanlal Sayana.

Journal Name: Current Drug Metabolism


The concept of evaluating bioequivalence is changing over a period of 50 years. The consequences of belief, deliberation, and guidance about bioequivalence among the regulatory agencies, pharmaceutical companies and institutions are the motivating force to explore and identify the different approaches in deciding the way forward in the assessment of generic products. Currently average bioequivalence approach (ABE) is the gold standard tool for the evaluation of generic drugs. The same tool (ABE) is used for the assessment of all the category of drugs like large therapeutic range drugs (LTI), narrow therapeutic range drugs (NTI) and highly variable drug products (HVDPs). In the recent past, many debates had arisen about employing average bioequivalence approach (ABE) for the assessment of all these drug categories. There are limitations of average bioequivalence approach (ABE) for the assessment of NTIs and HVDPs. The purpose of this review is to examine and understand the limitations of average bioequivalence approach (ABE), current regulatory thinking for assessing different drug categories, whether they are adequately assessed and the challenges for the future development.

Keywords: Critical Dose Drugs, Average Bioequivalence, Individual Bioequivalence, Population Bioequivalence, Drug Interchangeability, Prescribability, Switchability

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(E-pub Ahead of Print)
DOI: 10.2174/1389200220666191007152542
Price: $95

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