Pharmacokinetics in Drug Development: Regulatory and Development Paradigms (Volume 2)

ISBN-13: 9780971176737 / Angielski / Twarda / 2005 / 488 str.

Peter Bonate; Peter Bonate; Danny Howard

Opis

These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. The volumes fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.

Spis treści

Drug Development: A Rational Approach.- Experimental Design Considerations in Pharmacokinetic Studies.- Exposure-Response Relationships: A Critical Review of the FDA Guidance and Its Practical Utility.- Role fo Toxicology and Toxicokinetics in Drug Development.- Bioanaysis in a Regulated Environment.- Role of Preclinical Pharmacokinetics in Drug Development.- Pharmacokinetics/Pharmacodynamic Knowledge Discovery and Creation During Drug Development.- Regulatory Aspects of Clinical Pharmacokinetic Studies.- Regulatory Review of Pharmacokinetic Studies.- Regulatory Perspectives on Clinical Trial Simulations.- Nuances of Drug Metabolism and Pharmacokinetic Requirements for Package Submission to Japanese Regulatory Authorities.- Drug Development in Oncology.- Development of Chiral Compounds.- Development of Controlled-release Products.- Development Considerations for Biological Drugs.- Pharmacokinetics is Ocular Drug Development.- Development of Parenteral Dosage Forms.- Development of Transdermal Products.