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.
Mục lục
to Biopharmaceutics and its Role in Drug Development.- Molecular and Physicochemical Properties Impacting Oral Absorptionof Drugs.- Dissolution Testing.- Drug Absorption Principles.- Evaluation of Permeability and P-glycoprotein Interactions: Industry Outlook.- Excipients as Absorption Enhancers.- Intestinal Transporters 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.
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