Regulatory position Regulatory concerns
Current Regulatory Initiative
Perception of advantages Perception of concern
To further substantiate clinical endpoint data?
Proposal for guidance on PK-PD during drug development
Validate the pre-clinical PK/PD concept in phase I/II trials (before phase III trials)
Confirm the concept in confirmatory clinical endpoint studies
End product:Improved dose recommendation to prescribing doctors (SPC section 4.2, 5.1.)
To further substantiate clinical endpoint data? To allow extrapolation to other populations
Email: webmaster@isap.org
Home Page: http://www.isap.org/Birmingham-1999.htm