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Back to the forum  Query: 2017-09-25 22:34 CEST (UTC+2h)
 

syrup hybrid application [Regulatives / Guidelines]

posted by Aga - US, 2017-09-06 13:52  - Posting: # 17784
Views: 410

Hi,
How could we proof equivalence for syrups, to authorise strength 5 mg/ml when only lower strength of reference product is available (2 mg/ml)? BEQ? In vitro?
The substance is present for more than half of a century on the market and efficacy for tablet (10 and 25 mg) and syrup lower strength (2 mg/ml) is documented in the literature.
best regards,
Aga

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