Pharmacokinetics in Drug Development

Regulatory and Development Paradigms (Volume 2)
2004. Auflage 2005
ISBN: 978-0-9711767-3-7
Verlag: American Association of Pharmaceuticals Scientists

Buch, Englisch, 488 Seiten, Format (B × H): 254 mm x 178 mm, Gewicht: 1166 g

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.

Zielgruppe

Research

Autoren/Hrsg.

Bonate, Peter L

Howard, Danny R

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

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.