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Biowaiver monographs are literature reviews, in which publicly available data are gathered and organised to address the question of whether a biowaiver can be recommended for a new formulation of an active pharmaceutical ingredient (API). Parameters and points discussed are: solubility and permeability, dissolution of dosage forms, pharmacokinetics, the therapeutic use and therapeutic window of the API, data on excipient interactions and problems with bioavailability and/or bioequivalence.
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