Biowaiver for Emusion Dosage Form [Design Issues]

posted by surajpatel – India, 2021-05-11 10:27 (417 d 05:14 ago) – Posting: # 22339
Views: 1,026

Dear all,

Good morning.

One of our sponsor wants to conduct Bioequivalence study for an Emulsion formulation for intravenous route. Sponsor plans to market the drug as generic version of Innovator in South Africa. But, he enquired whether we can go for biowaiver instead of BE study for Emulsion formulation.

Suraj.

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