Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences) - 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.
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About the Author:
Sarfaraz K. Niazi is Chief Executive Officer, Pharmaceutical Scientist Inc., Deerfield, Illinois.
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- PublisherCRC Press
- Publication date2007
- ISBN 10 0849303958
- ISBN 13 9780849303951
- BindingHardcover
- Edition number1
- Number of pages550
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Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)
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Informa Healthcare
(2007)
ISBN 10: 0849303958
ISBN 13: 9780849303951
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Handbook of Bioequivalence Testing
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Taylor & Francis Group
(2007)
ISBN 10: 0849303958
ISBN 13: 9780849303951
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Book Description Condition: New. pp. xiv + 569 Illus. This item is printed on demand. Seller Inventory # 7342493
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