Back to the Top
I wonder if anyone know where to find information regarding
the questions below:
- If it is possible to change active substance during development
(After performance of a Phase I study)
and what information/documents does the Authorities requries it that
case? (FDA and EU)
- If it is possible to change the amount of an excipient during
development. (Antioxidantia) and what information/documents
does the Authorities requires? (FDA and EU)
I would most appreciate your comments on this.
Thank's in advance!
Best regards,
Anna Karlsson
Associate Regulatory Affairs
Orexo AB
Sweden
Back to the Top
These changes should be minimised because you will have a lot of
problems with some reg authorities. You can probably get away with a
briding bioequivalence study. It might even be that at phase 1 you
might simply get away with an in-vitro test as most of the clinical
will be done later.
But my strongest recommendation is to discuss it with the regulatory
authroties where you expect to file the IND or NDA.
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)