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Bonate / Howard

Pharmacokinetics in Drug Development

Clinical Study Design and Analysis (Volume 1)

Medium: Buch
ISBN: 978-0-9711767-4-4
Verlag: American Association of Pharmaceuticals Scientists
Erscheinungstermin: 05.12.2005
Lieferfrist: bis zu 10 Tage

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.


Produkteigenschaften


  • Artikelnummer: 9780971176744
  • Medium: Buch
  • ISBN: 978-0-9711767-4-4
  • Verlag: American Association of Pharmaceuticals Scientists
  • Erscheinungstermin: 05.12.2005
  • Sprache(n): Englisch
  • Auflage: 2004. Auflage 2005
  • Produktform: Gebunden
  • Gewicht: 1312 g
  • Seiten: 628
  • Format (B x H x T): 179 x 261 x 40 mm
  • Ausgabetyp: Kein, Unbekannt
Autoren/Hrsg.

Herausgeber

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.