Hi All,
I am a Masters of Regulatory Affairs student at Northeastern University and working on an assignment for suggesting a development plan – technical and clinical to support this biosimilar. I understand that this would include a brief outline of the types of technical studies (CMC), non clinical, clinical pharmacokinetic (PK/PD) and clinical studies that FDA would likely require to approve it. Any suggestions on why these studies will be required (including the detailed rationale) and any supporting material to read on this topic would be really appreciated.
Thank you
Sincerely,
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Pratik Pednekar
857-919-9958
prtkpednekar@outlook.comBoston MA
United States
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