Articles liés à Handbook of Bioequivalence Testing
Présentation de l'éditeur
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 description of every aspect of bioequivalence testing.
Features:
- Describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations
- Discusses worldwide regulatory requirements for filing for approval of generic drugs
- Covers GLP, GCP, and 21 CFR compliance requirements for qualifying studies for regulatory submission and facility certification
- Includes actual examples of reports approved by regulatory authorities to illustrate various scientific, regulatory, and formatting aspects
- Provides a list of vendors for the software used to analyze bioequivalence studies and recommendations
- Explains how to apply for a waiver, how to secure regulatory approval of reports, and how to obtain regulatory certification of facilities conducting bioequivalence studies
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- ÉditeurInforma Healthcare
- Date d'édition2007
- ISBN 10 0849303958
- ISBN 13 9780849303951
- ReliureRelié
- Numéro d'édition1
- Nombre de pages550
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Handbook Of Bioequivalence Testing, Dpss. 171
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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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Hardcover. Etat : New. Etat de la jaquette : no dust cover. This Book is New, Pages are clean bright and unmarked.569 pagesListing Includes Books Image. Please email me if you need to see more pictures! The orders are processed promptly, carefully packaged and shipped within 1 day of purchase. PLEASE NOTE! if you need the book quickly, please Purchase Priority Shipping. Media will not show updates in mail confirmation till reaches continental U.S. N° de réf. du vendeur SKU1055516
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Handbook of Bioequivalence Testing
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Taylor & Francis Group, 2007
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ISBN 13 : 9780849303951
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Handbook Of Bioequivalence Testing, Vol.171
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TAYLOR & FRANCIS, 2007
ISBN 10 : 0849303958
ISBN 13 : 9780849303951
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Handbook Of Bioequivalence Testing, Vol.171
Edité par
TAYLOR & FRANCIS, 2007
ISBN 10 : 0849303958
ISBN 13 : 9780849303951
Neuf
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Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)
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CRC Press, 2007
ISBN 10 : 0849303958
ISBN 13 : 9780849303951
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