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[资源]
Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)
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 Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)By Sarfaraz K. Niazi Publisher: Informa Healthcare Number Of Pages: 550 Publication Date: 2007-08-22 ISBN-10 / ASIN: 0849303958 ISBN-13 / EAN: 9780849303951 Binding: Hardcover 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. Link： http://mihd.net/sf0yda http://rapidshare.com/files/79513069/0849303958.rar http://rapidshare.com/files/7954 ... valence_Testing.zip [search]Handbook of Bioequivalence Testing (Drugs and t ...[/search] |
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