A BCS Class III API pharmaceutical product is formulated as…
A BCS Class III API pharmaceutical product is formulated as a test tablet containing a different binder from the reference product. The comparative dissolution testing shows rapid, not very rapid, dissolution (i.e. 85 % in 30 min) in all three media (pH 1,2, 4,5, 6,8) of both test and reference products. What is the biowaiver status of this product?
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