Pharmaceutical and Bioequivalence Criteria in Generic Drug Development

by Application of Green Reagents in Pharmaceutical Synthesis on Jun 19th, 2025 09:03 AM

To successfully develop and manufacture generic drugs, manufacturers must demonstrate that their product is pharmaceutically equivalent and bioequivalent to the reference listed drug (RLD), thereby establishing that two drugs are therapeutically equivalent. Two medicinal products can be considered pharmaceutically equivalent if they contain the same amount of the same active ingredient, have the same dosage form, and meet the same or comparable quality standards. Pharmaceutically equivalent formulations do not necessarily imply bioequivalence, since differences in excipients or differences in manufacturing processes may result in altered rates of drug dissolution or absorption.

Bioequivalence Evaluation is an important part of the consistency evaluation and registration of generic drugs. Manufacturers of generic medicines must comply with strict regulatory requirements for bioequivalence. 21 CFR 320.24 provides that generic drug manufacturers may use different types of evidence to determine the bioequivalence of their drugs, including in vivo and/or in vitro testing. The choice of method for bioequivalence proof depends on the purpose of the study and the nature of the drug product.