Evidence of effectiveness: How much can we extrapolate from existing studies?
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.
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- Evidence of effectiveness: How much can we extrapolate from existing studies?
The AAPS Journal
Volume 7, Issue 2 , pp E467-E474
- Cover Date
- Online ISSN
- Additional Links
- drug development science
- pharmacokinetic-pharmacodynamic modeling
- exposure-response relationship
- Industry Sectors
- Author Affiliations
- 1. Center for Clinical Pharmacology, University of Pittsburgh, 15219, Pittsburgh, PA
- 2. Center for Drug Development Science, Washington DC Center, 20036, Washington, DC
- 3. Clinical Pharmacology and Experimental Medicine, Centocor Inc, Johnson & Johnson, 19087, Radnor, PA