It will probably depend on what the new route of administration is and the potential impact on metabolite development and local tolerance effects. In general it would be advisable (required?) to do one species (most sensitive) for at least the duration of the clinical trial. Twice a day versus once a day will not really help any in the analysis of whether the duration of the study is sufficient. If no new safety signals are seen in the tested species compared to the approved API.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 16-Apr-2019 08:28
From: Anonymous Member
Subject: preclinical repeated dose trial prior 30 days clinical trial
This message was posted by a user wishing to remain anonymous
Hi
how likely is it to get approval for initiating a clinical trial with a known API (not a new molecule entity, but new route of administration) for 30 days and single dosing per day, based on a preclinical trial with rats at which dosing was twice a day for 5 days?