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Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023.

作者信息

Tsakalozou Eleftheria, Gong Yuqing, Babiskin Andrew, Hu Meng, Mousa Youssef, Walenga Ross, Wu Fang, Yoon Miyoung, Raney Sam G, Polli James E, Schwendeman Anna, Krishnan Vishalakshi, Fang Lanyan, Zhao Liang

机构信息

Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.

Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

出版信息

AAPS J. 2024 Apr 24;26(3):55. doi: 10.1208/s12248-024-00924-8.

DOI:10.1208/s12248-024-00924-8
PMID:38658449
Abstract
摘要

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本文引用的文献

1
Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop.利用建模和模拟提高仿制药生物等效性方法的效率：2023 年仿制药科学和研究倡议公开研讨会亮点。
AAPS J. 2024 Apr 8;26(3):45. doi: 10.1208/s12248-024-00916-8.
2
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA.模型主文件在与 FDA 共享、接受和沟通方面的作用。
AAPS J. 2024 Feb 27;26(2):28. doi: 10.1208/s12248-024-00897-8.
3
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products.
利用机制建模方法支持口服产品的生物等效性评估。
AAPS J. 2024 Jan 24;26(1):19. doi: 10.1208/s12248-024-00886-x.
4
Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development.发展定量比较方法以支持复杂仿制药的开发。
AAPS J. 2024 Jan 24;26(1):15. doi: 10.1208/s12248-024-00885-y.
5
Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products-a Meeting Report.在仿制药产品监管环境中使用模型整合证据的经验教训和观点——会议报告
AAPS J. 2024 Jan 10;26(1):14. doi: 10.1208/s12248-023-00884-5.
6
Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products.在多个提交中使用相同的模型或建模策略：关注复杂药物产品。
AAPS J. 2024 Jan 4;26(1):12. doi: 10.1208/s12248-023-00879-2.
7
Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery.定量方法和建模在生物等效性确立及药物递送特性表征中的影响日益增大。
CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):552-555. doi: 10.1002/psp4.12930. Epub 2023 Feb 9.
8
Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop.建立模型整合证据用于证明长效注射和植入药物产品生物等效性的适宜性：研讨会总结。
CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):624-630. doi: 10.1002/psp4.12931. Epub 2023 Feb 9.
9
Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview.机制建模在支持替代生物等效性方法中的监管效用：研讨会概述。
CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):619-623. doi: 10.1002/psp4.12920. Epub 2023 Feb 5.
10
Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report.基于生理学的药代动力学模型在生物等效性研究中评估食物影响的监管实用性：研讨会总结报告。
CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):610-618. doi: 10.1002/psp4.12913. Epub 2023 Jan 16.