2004D-0035 - Draft Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis; Availability
FDA Comment Number : EC1
Submitter : Dr. Joel Feinblatt Date & Time: 03/22/2004 03:03:41
Organization : Perceptive Informatics, Inc.
Category : Drug Industry
Issue Areas/Comments
A number of drugs of different classes of agents have been approved by the FDA since 1994. These have different potencies as well as half lives of activity. This is exemplified by the use of the bisphosphonate drugs with one member of this class being tested for a once-a-year administration demonstrating its long residence in bone. As a researcher assisting companies in the development of protocols for osteoporosis trials, a major issue of contention has been the exclusion of subjects based on previous treatment with one or more of the approved agents. There are many differences in the various protocols that I have worked with in regard to the duration of the wash-out from these drugs - particularly the bisphosphonate class - for a subject to be eligible for the trial. In addition to the major issues being addressed in the guidance with regard to placebo-controlled trials, fracture as an endpoint and duration of the trials, it would be very useful if the guidance could address a recommended washout period for each of the drugs relevant to treatment in order for subjects to be included in the trial. This would also assist in normalizing the patient populations across trials with regard to previous exposure to these treatments and any residual effects of the prior treatment on the response to the agent being assessed.
Thank you for this consideration.