Get Medicines Control Authority Of Zimbabwe Form: Evf 07 Biowaiver For Additional Strengths Application
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Requirements for a BCS-based biowaiver study include: a- Dissolution Test in 3 different media (in 900 ml and at 37°C) which are: Buffer pH 1.2, simulated gastric fluid without enzymes or 0.1N HCl. Buffer pH 4.5. Buffer pH 6.8 or simulated intestinal fluid without enzymes.
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