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The following message was posted to: PharmPK
Many thanks to everyone who contributes to this site. I think it's a
Does anyone konw what you have to submit to regulatory authorities in
order to get a generic peptide approved? In this case, what happens if
the original compound is produced biotechnologically and we could
produce it chemically with comparable puritiy . Is the preclinical
program plus a bioequivalence study sufficient?
Thank you very much for your thoughts!
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