The AAPS Journal

, Volume 7, Issue 2, pp E467–E474

Evidence of effectiveness: How much can we extrapolate from existing studies?

  • Howard Lee
  • Dong-Seok Yim
  • Honghui Zhou
  • Carl C. Peck
Article

DOI: 10.1208/aapsj070247

Cite this article as:
Lee, H., Yim, DS., Zhou, H. et al. AAPS J (2005) 7: E467. doi:10.1208/aapsj070247

Abstract

Drug development can be a science of extrapolation if the use of a drug exposure-response relationship is embraced and implemented through mechanistically oriented pharmacokinetic (PK)-pharmacodynamic (PD) modeling analysis and clinical trial simulation. The traditional requirement of at least 2 adequate and well-controlled phase III studies by the US Food and Drug Administration for drug approval can be waived in certain situations, substantially reducing the resources and time. In this article, the authors introduce a real drug development case where the chance for this exemption was maximized by actively using PK-PD modeling followed by clinical trial simulation, resulting in faster and more economical introduction of a new dosage regimen to patients.

Keywords

extrapolationdrug development sciencepharmacokinetic-pharmacodynamic modelingexposure-response relationshipetanercept

Copyright information

© American Association of Pharmaceutical Scientists 2005

Authors and Affiliations

  • Howard Lee
    • 1
  • Dong-Seok Yim
    • 2
  • Honghui Zhou
    • 3
  • Carl C. Peck
    • 2
  1. 1.Center for Clinical PharmacologyUniversity of PittsburghPittsburgh
  2. 2.Center for Drug Development ScienceWashington DC CenterWashington, DC
  3. 3.Clinical Pharmacology and Experimental MedicineCentocor Inc, Johnson & JohnsonRadnor