Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective

Kollipara, Sivacharan; Bhattiprolu, Adithya Karthik; Boddu, Rajkumar; Ahmed, Tausif; Chachad, Siddharth

doi:10.1208/s12249-023-02521-y

Cited by 14 publications

(2 citation statements)

References 45 publications

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“…Despite the promising results mentioned above, it is essential to recognize the limitations of modeling in forecasting BE across various formulations. The precision and trustworthiness of the predictions are greatly influenced by the accessibility and quality of the input parameters, which encompass drug physicochemical and biopharmaceutical attributes, along with physiological factors 24 . Furthermore, it is also recognized that certain aspects of these models necessitate enhancement, including the incorporation of enzymatic and transporter activities, as well as the assessment of excipient effects on dissolution and permeation.…”

Section: Discussionmentioning

confidence: 99%

Physiologically based absorption modeling to predict the bioequivalence of two apixaban formulations

Luo,

Wang,

Ruan

et al. 2024

Clinical Translational Sci

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The equivalence of absorption rates and extents between generic drugs and their reference formulations is crucial for ensuring therapeutic comparability. Bioequivalence (BE) studies are widely utilized and play a pivotal role in substantiating the approval and promotional efforts for generic drugs. Virtual BE simulation is a valuable tool for mitigating risks and guiding clinical BE studies, thereby minimizing redundant in vivo BE assessments. Herein, we successfully developed a physiologically based absorption model for virtual BE simulations, which precisely predicts the BE of the apixaban test and reference formulations. The modeling results confirm that the test and reference formulations were bioequivalent under both fasted and fed conditions, consistent with clinical studies. This highlights the efficacy of physiologically based absorption modeling as a powerful tool for formulation screening and can be adopted as a methodological and risk assessment strategy to detect potential clinical BE risks.

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Section: Discussionmentioning

confidence: 99%

Physiologically based absorption modeling to predict the bioequivalence of two apixaban formulations

Luo,

Wang,

Ruan

et al. 2024

Clinical Translational Sci

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“…It is also interesting to note that nowadays, several software packages are available to simulate the dissolution of drugs under different conditions, such as DDDPlus [ 18 ], DDSolver [ 116 ], or SIVA toolkit [ 117 ]. These software tools can greatly facilitate and accelerate the selection of the in vivo relevant conditions for in vitro testing, as demonstrated in several publications [ 118 , 119 , 120 , 121 , 122 ]. However, these tools are still being improved and their potential is not yet sufficiently exploited.…”

Section: Drug Release Modelingmentioning

confidence: 99%

Model-Informed Drug Development: In Silico Assessment of Drug Bioperformance following Oral and Percutaneous Administration

Djuris,

Cvijic,

Djekic

2024

Pharmaceuticals

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The pharmaceutical industry has faced significant changes in recent years, primarily influenced by regulatory standards, market competition, and the need to accelerate drug development. Model-informed drug development (MIDD) leverages quantitative computational models to facilitate decision-making processes. This approach sheds light on the complex interplay between the influence of a drug’s performance and the resulting clinical outcomes. This comprehensive review aims to explain the mechanisms that control the dissolution and/or release of drugs and their subsequent permeation through biological membranes. Furthermore, the importance of simulating these processes through a variety of in silico models is emphasized. Advanced compartmental absorption models provide an analytical framework to understand the kinetics of transit, dissolution, and absorption associated with orally administered drugs. In contrast, for topical and transdermal drug delivery systems, the prediction of drug permeation is predominantly based on quantitative structure–permeation relationships and molecular dynamics simulations. This review describes a variety of modeling strategies, ranging from mechanistic to empirical equations, and highlights the growing importance of state-of-the-art tools such as artificial intelligence, as well as advanced imaging and spectroscopic techniques.

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Dissolution of pain-relief drugs: Does beverage choice matter?

Huang,

Salim,

Barber

et al. 2024

Journal of Drug Delivery Science and Technology

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Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective

Cited by 14 publications

References 45 publications

Physiologically based absorption modeling to predict the bioequivalence of two apixaban formulations

Physiologically based absorption modeling to predict the bioequivalence of two apixaban formulations

Model-Informed Drug Development: In Silico Assessment of Drug Bioperformance following Oral and Percutaneous Administration

Dissolution of pain-relief drugs: Does beverage choice matter?

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