Starting Dose Guidance Should Allow Alternate Methods – Merck, Bristol
Executive Summary
FDA should expand on alternative methods for selecting a starting dose in clinical trials in addition to the algorithm recommended in a draft guidance, Merck and Bristol-Myers Squibb say in comments
You may also be interested in...
Starting dose final guidance
FDA final guidance on "FDL-1Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers," released July 22, provides an algorithm by which maximum recommended starting dose (MRSD) can be selected for first-in-human clinical trials. Document generally reflects draft version. The process outlined for calculating MRSD uses administered doses, observed toxicities and an algorithmic approach, although "an alternative approach could be proposed that places primary emphasis on animal pharmacokinetics and modeling rather than dose," FDA says. Merck and Bristol-Myers Squibb had requested that the process include alternate methods for deriving MRSD rather than a single approach (1"The Pink Sheet" May 12, 2003, p. 23)...
Starting dose final guidance
FDA final guidance on "FDL-1Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers," released July 22, provides an algorithm by which maximum recommended starting dose (MRSD) can be selected for first-in-human clinical trials. Document generally reflects draft version. The process outlined for calculating MRSD uses administered doses, observed toxicities and an algorithmic approach, although "an alternative approach could be proposed that places primary emphasis on animal pharmacokinetics and modeling rather than dose," FDA says. Merck and Bristol-Myers Squibb had requested that the process include alternate methods for deriving MRSD rather than a single approach (1"The Pink Sheet" May 12, 2003, p. 23)...
Dose Ranging Study In Phase III Could Bolster Rx Safety Profile, Temple Says
Evaluating a range of doses in Phase III clinical trials could bolster the safety profile for an investigational new agent, FDA Office of Medical Policy Director Robert Temple, MD, said April 9