Pharmacokinetics in Drug Development

Clinical Study Design and Analysis (Volume 1)

Peter L. Bonate, Danny R. Howard (Herausgeber)

Buch | Hardcover

628 Seiten

2005 | 2004 ed.
AAPS Press (Verlag)
978-0-9711767-4-4 (ISBN)

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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.

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.

Erscheint lt. Verlag	5.12.2005
Zusatzinfo	XII, 628 p.
Verlagsort	Arlington, VA
Sprache	englisch
Maße	178 x 254 mm
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
Themenwelt	Medizin / Pharmazie ► Pharmazie
ISBN-10	0-9711767-4-4 / 0971176744
ISBN-13	978-0-9711767-4-4 / 9780971176744
Zustand	Neuware