DOI: 10.21276/ajptr
Tue, 25 Jun 2019

The Basic Regulatory Considerations for Generic Drugs and Bioequivalence Studies an Overview

Mokkapati Phani Chand1*, Krishna Kiran Gupta Juvvala1, Prashanth Chilka1

1.Department of Regulatory Affairs, Freyr Inc, Hyderabad -500001.


Bioavailability and Bioequivalence studies play a vital role in drug development process for new drug products and generic drugs. The main aim of abbreviated new drug application is to show that the generic drug is bioequivalent to innovator product in terms of quality, safety, and efficacy. There are several approaches to study bioequivalence and each country has its own regulations for conducting Bioavailability and Bioequivalence studies. The present review gives information about abbreviated new drug application submission and important aspects involved in bioequivalence and Regulatory requirement for various countries.

Keywords: FDA:  Food and Drug Administration, EMA: European medical agency, BA/BE: Bioavailability and Bioequivalence, AUC: Area under Curve, ANDA: Abbreviated new drug application

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