ABSTRACT

Published in 1994: This text focuses on the determination of bioequivalence between formulations that are pharmaceutically equivalent and manufactured using acceptable chemistry, manufacturing and controls and in accordance with Good Manufacturing Practices.

chapter 6|12 pages

In Vivo and In Vitro Correlations

Scientific and Regulatory Perspectives

chapter Commentary I|8 pages

Issues in Bioequivalence:

An Industrial Scientist’s Perspective