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The following message was posted to: PharmPK
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.
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