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Handbook of Bioequivalence Testing
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Main description:

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.


Contents:

Bioequivalence Testing. Regulatory Aspect of Bioequivalence Testing. Pharmacokinetic/Pharmacodynamic Modeling. Waiver of BA/BE Studies. Regulatory Review Process. Statistical Evaluation of Bioequivalence Data. Physicochemical Properties. Drug Delivery Factors. Bioanalytical Method Validation. Good Clinical Practice. Good Laboratory Practice for Nonclinical Lab Studies. Computer and Software Validations. Bioequivalence Reports


PRODUCT DETAILS

ISBN-13: 9780849383595
Publisher: Informa Healthcare
Publication date: August, 2007
Pages: 550
Dimensions: 178.00 x 254.00 x 32.00

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