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Alle Exemplare der Ausgabe mit dieser ISBN anzeigen:"This handbook offers a complete description of every aspect of bioequivalence testing ... [It] is an essential, one-of-a-kind resource for anyone interested in bioequivalence. There are no other books that compile so many aspects in one place."
―Jennifer L. Colon, PharmD, Temple University School of Pharmacy, in Doody’s Review Service
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements.
New topics include:
The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval―including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs―allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.
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Buchbeschreibung Zustand: Brand New. New. US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service. Bestandsnummer des Verkäufers ABEOCT23-137118
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Buchbeschreibung Zustand: New. Brand New Original US Edition. Customer service! Satisfaction Guaranteed. This item may ship from the US or our Overseas warehouse depending on your location and stock availability. We Ship to PO BOX Location also. Bestandsnummer des Verkäufers ABRR-80001
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Buchbeschreibung Zustand: Brand New. New. US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service. Bestandsnummer des Verkäufers ABEOCT23-137119
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Buchbeschreibung Zustand: New. Brand New Original US Edition.We Ship to PO BOX Address also. EXPEDITED shipping option also available for faster delivery.This item may ship from the US or other locations in India depending on your location and availability. Bestandsnummer des Verkäufers ABTR-51763
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Buchbeschreibung Zustand: New. Brand New Original US Edition. Customer service! Satisfaction Guaranteed. This item may ship from the US or our Overseas warehouse depending on your location and stock availability. We Ship to PO BOX Location also. Bestandsnummer des Verkäufers ABRR-51763
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Buchbeschreibung Zustand: New. pp. 1020 2nd Edition. Bestandsnummer des Verkäufers 2698170352
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Buchbeschreibung Zustand: New. pp. 1020 approx. 153 equations. Bestandsnummer des Verkäufers 95308335
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Buchbeschreibung Zustand: New. Bestandsnummer des Verkäufers 21736262-n
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