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Inhaltsangabe
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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Über die Autorin bzw. den Autor
Sarfaraz K. Niazi is Chief Executive Officer, Pharmaceutical Scientist Inc., Deerfield, Illinois.
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Handbook Of Bioequivalence Testing, Dpss. 171
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Handbook of Bioequivalence Testing
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Handbook Of Bioequivalence Testing, Vol.171
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Zustand: New. Brand New. Soft Cover International Edition. Different ISBN and Cover Image. Priced lower than the standard editions which is usually intended to make them more affordable for students abroad. The core content of the book is generally the same as the standard edition. The country selling restrictions may be printed on the book but is no problem for the self-use. This Item maybe shipped from US or any other country as we have multiple locations worldwide. Bestandsnummer des Verkäufers ABNR-67830
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Handbook Of Bioequivalence Testing, Vol.171
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Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)
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