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. ...
Get Quantitative Methods for Traditional Chinese Medicine Development now with the O’Reilly learning platform.
O’Reilly members experience books, live events, courses curated by job role, and more from O’Reilly and nearly 200 top publishers.
