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Biopharmaceutics Applications in Drug Development

Rajesh Krishna, Lawrence Yu (Herausgeber)

Buch | Hardcover
396 Seiten
2007 | 2008 ed.
Springer-Verlag New York Inc.
978-0-387-72378-5 (ISBN)

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Biopharmaceutics Applications in Drug Development -
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The past two decades have witnessed considerable advances in biopharmaceutics, particularly with regard to bioavailability/bioequivalence, product quality and regulatory standards of approval.Biopharmaceutics Applications in Drug Development presents readers with step-wise, detail-conscious information to develop quality pharmaceuticals.
Drug performance is a vital aspect of new drug development as it draws on interdisciplinary expertise from both pharmaceutics and pharmacokinetics disciplines. It is at the key interface that the discipline of biopharmaceutics has emerged. The past two decades have witnessed considerable advances in biopharmaceutics, particularly with regard to bioavailability/bioequivalence, product quality and regulatory standards of approval.


Biopharmaceutics Applications in Drug Development presents readers with step-wise, detail-conscious information to develop quality pharmaceuticals. It is composed of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality, with specific focus on integration of regulatory considerations and case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.

to Biopharmaceutics and its Role in Drug Development.- Molecular and Physicochemical Properties Impacting OralAbsorptionofDrugs.- Dissolution Testing.- Drug Absorption Principles.- Evaluation of Permeability and P-glycoprotein Interactions: Industry Outlook.- Excipients as Absorption Enhancers.- IntestinalTransporters in Drug Absorption.- Bioavailability and Bioequivalence.- A Biopharmaceutical Classification System Approach to Dissolution: Mechanisms and Strategies.- Food Effects on Drug Bioavailability: Implications for New and Generic Drug Development.- In Vitro–In Vivo Correlation on Parenteral Dosage Forms.- In Vitro–In Vivo Correlation in Dosage Form Development: Case Studies.

Erscheint lt. Verlag 26.11.2007
Zusatzinfo XXII, 396 p.
Verlagsort New York, NY
Sprache englisch
Maße 155 x 235 mm
Themenwelt Medizin / Pharmazie Medizinische Fachgebiete Pharmakologie / Pharmakotherapie
Medizin / Pharmazie Pharmazie
Naturwissenschaften Biologie Biochemie
Technik
ISBN-10 0-387-72378-1 / 0387723781
ISBN-13 978-0-387-72378-5 / 9780387723785
Zustand Neuware
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