Pharmacokinetics in Drug Development

Clinical Study Design and Analysis (Volume 1)
2004. Auflage 2005
ISBN: 978-0-9711767-4-4
Verlag: American Association of Pharmaceuticals Scientists

Buch, Englisch, 628 Seiten, Format (B × H): 179 mm x 261 mm, Gewicht: 1312 g

These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. They 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

First-Time-in-Man Studies.- Drug-Drug Interactions.- Food Effect Studies.- Bioavailability and Bioequivalence Studies.- Mass Balance Studies.- Design, Conduct, and Analysis of Studies in Patients with Hepatic Impairment.- Design, Conduct, and Analysis of Studies in Patients with Renal Impairment.- Special Populations.- Non-compartmental Analysis.- Analysis of Urine Excretion Data.- Compartmental Models.- The Role of Metabolite Pharmacokinetics and Pharmacodynamics in Drug Development.- Average, Population, and Individual Bioequivalence.- Assessment of Dose Proportionality.- Analysis of Absorption Kinetic Data.- Interspecies Pharmacokinetic Scaling: Principles, Applications, and Limitations.- In Vitro Drug Metabolism Information in the Prediction of Human Pharmacokinetics.- Practical Deconvolution.- Population Pharmacokinetics: Applications in Industry.- Clinical Trial Simulation.- The Strategic Role and Application of Pharmacokinetic/Pharmacodynamic Modeling in Drug Development.- The Analysis of Clincal Safety Data in Phase I-II Pharmacokinetic Studies.