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Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)

Posted on 2010-03-15




Name:Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)
ASIN/ISBN:0849303958
Language:English
File size:17 Mb
Publisher: Informa Healthcare
Publish Date: 2007-08-22
ISBN: 0849303958
Pages: 550
File Type: PDF
File Size: 17 MB
   Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)

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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.

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