Chapter 10

Bioavailability and Bioequivalence

10.1 Introduction

In 1984, the US Congress passed the Drug Price Competition and Patent Term Restoration Act, which allows a regulatory framework for a low-cost pathway for generic drug products to enter the market. This Act gives the FDA the authority to approve a generic drug product via an Abbreviated New Drug Application (ANDA). As a result, when an innovative (brand name) drug product is going off patent, pharmaceutical or generic companies can file an ANDA for generic approval. For approval of a generic drug product, most regulatory agencies require evidence of average bioavailability (in terms of extent and rate of drug absorption) be provided through the conduct of bioequivalence studies. ...

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