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Bonate / Howard

Pharmacokinetics in Drug Development

Regulatory and Development Paradigms (Volume 2)

Medium: Buch
ISBN: 978-0-9711767-3-7
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. 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.


Produkteigenschaften


  • Artikelnummer: 9780971176737
  • Medium: Buch
  • ISBN: 978-0-9711767-3-7
  • Verlag: American Association of Pharmaceuticals Scientists
  • Erscheinungstermin: 05.12.2005
  • Sprache(n): Englisch
  • Auflage: 2004. Auflage 2005
  • Produktform: Gebunden
  • Gewicht: 1166 g
  • Seiten: 488
  • Format (B x H x T): 254 x 178 x 27 mm
  • Ausgabetyp: Kein, Unbekannt
Autoren/Hrsg.

Herausgeber

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.