Pharmacokinetics in Drug Development: Regulatory and Development Paradigms (Volume 2) (Biotechnology: Pharmaceutical Aspects) - gebonden uitgave, pocketboek

These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. Geared toward graduate level students and scientists in the areas of clinical pharmacology and PK, the volumes will 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, including first-time-in-man, biopharmaceuticals, and special population studies. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development. TOC: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.