Biopharmaceutics Applications in Drug Development [electronic resource] /
Krishna, Rajesh.editor.
Yu, Lawrence.editor.
In the last two decades, the discipline of biopharmaceutics has undergone considerable advances, particularly with regard to bioavailability and bioequivalence as they relate to product quality and regulatory standards of approval. Textbooks in the field have not been able to keep up with the growth of current and emerging applications of regulatory aspects of biopharmaceutics. Biopharmaceutics Applications in Drug Development fills this gap. This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.
Description based upon print version of record.
Includes bibliographical references and index.
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.
In the last two decades, the discipline of biopharmaceutics has undergone considerable advances, particularly with regard to bioavailability and bioequivalence as they relate to product quality and regulatory standards of approval. Textbooks in the field have not been able to keep up with the growth of current and emerging applications of regulatory aspects of biopharmaceutics. Biopharmaceutics Applications in Drug Development fills this gap. This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.
Pharmacology.
Biochemistry.
Pharmacology/Toxicology.
Biochemistry, general.