Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms Using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies.
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DOI: 10.1016/j.xphs.2021.09.017
Abstract: For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution and absorption. In the context of drug product quality, safe space is defined as the boundaries of in vitro… read more here.
Keywords: space; case studies; physiologically based; based biopharmaceutics ... See more keywords
Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective
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DOI: 10.1208/s12249-023-02521-y
Abstract: Dissolution is considered as a critical input into physiologically based biopharmaceutics models (PBBM) as it governs in vivo exposure. Despite many workshops, initiatives by academia, industry, and regulatory, wider practices are followed for dissolution data input… read more here.
Keywords: dissolution; dissolution data; models pbbm; physiologically based ... See more keywords