Search results with tag "Biowaiver approaches for solid oral dosage"

Biowaiver Approaches for Solid Oral Dosage Forms in ... - …

Dec 06, 2018 · Case Example 2 – Biowaiver for Pharmaceutical Alternative • BCS class 1 based biowaiver for pharmaceutical alternative drug product – Change from tablet to capsule • Data to support – High solubility – High permeability – Rapid dissolution in multimedia (>90% in 10 min) – Excipient differences were not expected to alter BA

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