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Dear readers,
If one find a new application for a combination of two existing drugs where both have proven safety data, does one have to study additional pre-clinical safety studies for the combination before doing any clinical studies? If so what are guidelines? What guidelines are out there for combination therapy? Can any body give information on FDA 505-B2 guidelines? or, what does that mean?
Sincerely,
Thomasapy
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The following message was posted to: PharmPK
Dear Thomasapy
It depends on what is meant by proven safety data - are the agents
approved as monotherapies for the indication intended in the combination
regimen?
The ICH M3 (R2) indicates situations where nonclinical studies may be
required - http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073246.pdf
Depending on the compounds, the toxicology and the clinical experience,
this document should provide some indication of the preclinical program
that may be required to support clinical studies or marketing.
Hope this helps
Keith Dredge.
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Clarification on my previous question on Combination therapy is - Both compounds are currently used as monotherapy for separate indications and is in the market for more than twenty years. Combination studies in rats indicate that they don't interfere each other as shown by no change in AUC's and Cmax's. Identical results are obtained whether combination or as singletons. No modification of CYP activities (induction or inhibition) or any effect on oral absorption. The question is, do we need to do additional toxicity studies before doing clinical trials? Or still has to conduct normal preclinical tox. studies? Where can I find FDA guidelines regarding this?
Thanks for suggestions,
Thomas Nadakal
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