Handbook of Bioequivalence Testing

Summary

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, the methods used to demonstrate bioequivalence have changed significantly, and this title covers all aspects of conducting these studies based on the newer requirements and the expectations of the regulatory agencies. Handbook of Bioequivalence Testing offers a complete and up-to-date description of every aspect of bioequivalence testing, including applying for a waiver of bioequivalence and securing regulatory approval of the reports, as well as preparing to secure regulatory certification of facilities conducting the studies.

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