Back to the Top
The following message was posted to: PharmPK
Dear All,
International guidelines allow for waiver of drugs formulated as solutions.
However, they do not specify if aqueous or not (oral). My question is about
ibuprofen formulated in soft gelatin capsules and totally dissolved in a
cosolvent. Is being in a solution form justifies exemption from BE studies
for this drug (class II).
Dr. Mutasim Al-Ghazawi, Ph.D.
|
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 "Biowaiver for Soft gelatin capsules" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)