Back to the Top
Dear Sirs:
Are you aware of any scientific support for the bioequivalence of
ramipril and ramiprilat. Knowing ramipril is a prodrug, what studies
are available to support that the beneficial clinical effects are
from the active metabolite, ramiprilat and that ramipril is inactive
or almost inactive? Is anyone aware of support for perindopril and
enalapril as to bioequivalence of their respective active metabolites?
Sincerely,
RobWear.-a-.aol.com
Back to the Top
The following message was posted to: PharmPK
Response to:
Re: BE studies Ramipril and Ramiprilat
Dear Rob,
Whatever scientific support you have, you are required to perform
bioequivalence study with Ramipril and you have to measure both
Ramipril and
the active metabolite Ramiprilat. These are the FDA requirements.
See also:
http://www.fda.gov/cder/guidance/bioequivalence/recommendations/
Ramipril_cap_19901_RC5-05.pdf
It is also identical for Enalapril.
Sincerely,
TS
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "BE studies Ramipril and Ramiprilat" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)