Bioequivalence and Bioavailability Forum • BCS-based Biowaiver

BCS-based Biowaiver [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2008-09-25 17:48 (6485 d 13:03 ago) – Posting: # 2408
Views: 28,008

Dear all!

BCS-based Biowaiver, IV.1.1 General aspects, page 26 (lines 985-990)
'Comparative in vitro dissolution experiments should follow current compendial standards. [...] Usual experimental conditions are e.g.: [...]

Volume of dissolution medium: 500 ml'

No, usual compendial standards are not 500 ml, but 250 ml! We know that guidelines easily are interpreted as laws, both by regulators and the industry - what now? Follow pharmacopeias and perform the test in 250 ml (and rely on the 'e.g.' before 500 ml), or discard all established methods and develop new ones in 500 ml media?
BTW, 500 ml are in contradiction to all (?) references published on the BCS...

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Helmut Schütz

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