ISBN 9780849303951,Handbook Of Bioequivalence Testing

Handbook Of Bioequivalence Testing



Routledge a Taylor & Francis Group

Publication Year 2007

ISBN 9780849303951

ISBN-10 0849303958

Hard Back

Number of Pages 569 Pages
Language (English)

Engineering measurement & calibration

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 offers a complete and timely description of every aspect of bioequivalence testing, including worldwide regulatory requirements for filing for approval of generic drugs, applying for a waiver, securing regulatory approval of reports, and obtaining regulatory certification of facilities conducting bioequivalence studies.