Bioequivalence and Bioavailability Forum

Surfactant in Biowaiver media [Dissolution / BCS / IVIVC]

posted by Helmut  – Vienna, Austria, 2014-12-16 15:00 (4214 d 05:46 ago) – Posting: # 14084
Views: 6,549

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”, ). However, “The use of any surfactant is not acceptable” is unambiguous.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Surfactant in Biowaiver media Amira 2014-12-15 14:10 
  • Surfactant in Biowaiver media Helmut 2014-12-15 14:16
    • Surfactant in Biowaiver media luvblooms 2014-12-16 05:29
      • Surfactant in Biowaiver mediaHelmut 2014-12-16 14:00
        • Surfactant in Biowaiver media Amira 2014-12-18 08:35