Author: Sarfaraz K. Niazi
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful
bioequivalence studies. In recent years, there have been significant changes to the
statistical models for evaluating bioequivalence, and advances in the
analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing covers all aspects of conducting these studies based on these newer requirements and the expectations of the regulatory agencies.
