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This reference provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications. Compiling key issues and current research on safety, efficacy, and clinical pharmacology, and PK-PD, this volume critically highlights the multidisciplinary nature of drug development and spans the fields of pharmacokinetics, clinical pharmacology, biostatistics, and experimental medicine.

This volume is an important advancement in the application ofpharmacokinetic (PK) and pharmacodynamic (PO) principles to . drug development. The series of topics presented deal with the application of these tools to everyday decisions that a pharmaceutical scientist encounters. The ability to integrate these topics using PK and PO methods has optimized drug development pathways in the clinic. New technologies in the areas of in vitro assays that are more predictive of human absorption and metabolism and advancement in bioanalytical assays are leading the way to minimize drug failures in...

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...

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...

This book, edited by two innovative leaders in the field, focuses on the new discipline of translational medicine as it pertains to drug development within the pharmaceutical and biotechnology industry. Translational medicine seeks to translate biological and molecular knowledge of disease and how drugs work into innovative development strategies that reduce the cost and increase the speed of delivering new medicines for patients. This book outlines general strategies, biomarker development, imaging tools, translational human models and examples of their application to real drug development....

Focuses on the new discipline of translational medicine as it pertains to drug development within the pharmaceutical and biotechnology industry.

This volume is an important advancement in the application ofpharmacokinetic (PK) and pharmacodynamic (PO) principles to . drug development. The series of topics presented deal with the application of these tools to everyday decisions that a pharmaceutical scientist encounters. The ability to integrate these topics using PK and PO methods has optimized drug development pathways in the clinic. New technologies in the areas of in vitro assays that are more predictive of human absorption and metabolism and advancement in bioanalytical assays are leading the way to minimize drug failures in...