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In Vitro Dissolution and in Silico Modeling Shortcuts in Bioequivalence Testing

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Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Ajman University, P.O. Box 346, Ajman, UAE
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Department of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University, P.O. Box 346, Ajman, UAE
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Author to whom correspondence should be addressed.
Pharmaceutics 2020, 12(1), 45; https://doi.org/10.3390/pharmaceutics12010045
Received: 6 December 2019 / Revised: 31 December 2019 / Accepted: 2 January 2020 / Published: 4 January 2020
(This article belongs to the Special Issue Mechanistic In Vitro and In Silico Modeling of Oral Drug Absorption)
Purpose: To review in vitro testing and simulation platforms that are in current use to predict in vivo performances of generic products as well as other situations to provide evidence for biowaiver and support drug formulations development. Methods: Pubmed and Google Scholar databases were used to review published literature over the past 10 years. The terms used were “simulation AND bioequivalence” and “modeling AND bioequivalence” in the title field of databases, followed by screening, and then reviewing. Results: A total of 22 research papers were reviewed. Computer simulation using software such as GastroPlus™, PK-Sim® and SimCyp® find applications in drug modeling. Considering the wide use of optimization for in silico predictions to fit observed data, a careful review of publications is required to validate the reliability of these platforms. For immediate release (IR) drug products belonging to the Biopharmaceutics Classification System (BCS) classes I and III, difference factor (ƒ1) and similarity factor (ƒ2) are calculated from the in vitro dissolution data of drug formulations to support biowaiver; however, this method can be more discriminatory and may not be useful for all dissolution profiles. Conclusions: Computer simulation platforms need to improve their mechanistic physiologically based pharmacokinetic (PBPK) modeling, and if prospectively validated within a small percentage of error from the observed clinical data, they can be valuable tools in bioequivalence (BE) testing and formulation development. View Full-Text
Keywords: bioequivalence; in silico pharmacokinetic simulations; similarity factor; dissolution; publication bias; biowaiver; biopharmaceutics classification system bioequivalence; in silico pharmacokinetic simulations; similarity factor; dissolution; publication bias; biowaiver; biopharmaceutics classification system
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Al-Tabakha, M.M.; Alomar, M.J. In Vitro Dissolution and in Silico Modeling Shortcuts in Bioequivalence Testing. Pharmaceutics 2020, 12, 45.

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