推进口服药物的虚拟生物等效性:方法、实际应用和未来展望

Pharmaceuticals Pub Date : 2024-07-03 DOI:10.3390/ph17070876
S. Kollipara, Frederico Martins, Rebeka Jereb, Dejan Krajcar, Tausif Ahmed
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引用次数: 0

摘要

生物等效性研究是仿制药开发的关键,它提供了与创新产品的治疗等效性。然而,由于药物、制剂、生理学和药代动力学等多种因素的相互作用,生物等效性研究非常复杂。基于生理学的生物药剂学建模(PBBM)等方法可以通过适当开发和验证的模型进行虚拟生物等效性(VBE)评估。目前,此类模型已被广泛用于生物等效性风险评估、内部决策以及与生物等效性相关的药物和制剂因素评估。在使用此类模型时,最重要的是通过纳入变异性和开发生物等效性评估的虚拟人群来描述上述因素。在本手稿中,我们阐述了目前对虚拟生物等效性的理解。我们详细解释了研究设计、体内变异性以及生理、药物和制剂因素对 VBE 群体开发的影响。此外,还提出了将变异性纳入 GastroPlus 的策略,重点是受试者内和受试者间的变异性。还介绍了与速释和改良释放制剂有关的两个工业案例研究,其中 VBE 被用于决策和监管论证。最后,详细介绍了对 VBE 领域的监管理解以及未来展望。
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Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook
Bioequivalence studies are pivotal in generic drug development wherein therapeutic equivalence is provided with an innovator product. However, bioequivalence studies represent significant complexities due to the interplay of multiple factors related to drug, formulation, physiology, and pharmacokinetics. Approaches such as physiologically based biopharmaceutics modeling (PBBM) can enable virtual bioequivalence (VBE) assessment through appropriately developed and validated models. Such models are now being extensively used for bioequivalence risk assessment, internal decision-making, and the evaluation of drug and formulation factors related to bioequivalence. Depiction of the above-mentioned factors through the incorporation of variability and development of a virtual population for bioequivalence assessment is of paramount importance in utilizing such models. In this manuscript, we have portrayed our current understanding of VBE. A detailed explanation was provided with respect to study designs, in vivo variability, and the impact of physiological, drug, and formulation factors on the development of the population for VBE. Furthermore, strategies are suggested to incorporate variability in GastroPlus with an emphasis on intra-subject and inter-occasion variability. Two industrial case studies pertaining to immediate and modified release formulation were portrayed wherein VBE was utilized for decision-making and regulatory justification. Finally, regulatory understanding in the area of VBE, along with future perspectives, was detailed.
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