Surfactant in Biowaiver media [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2014-12-16 15:00 (3777 d 20:32 ago) – Posting: # 14084
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Hi Luv & Amira

❝ Which biowaiver we are talking about?

❝ a) If BCS based biowaiver to be proposed then NEVER

❝ b) If biowaiver for strengths other than bio strength: YES


I assumed a) because Amira wrote

❝ ❝ as guidelines state that the 3 pH medias are done without surfactant


GLs sometimes leave space for interpretation (“should be”, “appropriate”, “if justified”, :blahblah:). However, “The use of any surfactant is not acceptable” is unambiguous.

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