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The following message was posted to: PharmPK
Hello everybody,
Do you know if a dimer, that in vivo was bioconverted to the monomer
(well
known product), could be considered a NCE. What sort of "new" studies
would
be mandatory for FDA submission? Toxicological ones?
Thank you in advance.
Jose Antonio Cordero
Ipsen Pharma S.A.
Barcelona
Spain
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