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本文引用的文献

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Generating Model Integrated Evidence for Generic Drug Development and Assessment.生成用于仿制药开发和评估的模型综合证据。
Clin Pharmacol Ther. 2019 Feb;105(2):338-349. doi: 10.1002/cpt.1282. Epub 2019 Jan 20.
2
Regulatory framework on bioequivalence criteria for locally acting gastrointestinal drugs: the case for oral modified release mesalamine formulations.局部作用胃肠道药物生物等效性标准的监管框架：口服改性释放美沙拉嗪制剂的情况。
Expert Rev Clin Pharmacol. 2017 Sep;10(9):1007-1019. doi: 10.1080/17512433.2017.1348227. Epub 2017 Jul 6.
3
Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop.用于制剂开发和生物等效性评估的机制性口服吸收建模与模拟：美国食品药品监督管理局公开研讨会报告
CPT Pharmacometrics Syst Pharmacol. 2017 Aug;6(8):492-495. doi: 10.1002/psp4.12204. Epub 2017 Jul 11.
4
Measurement of in vivo Gastrointestinal Release and Dissolution of Three Locally Acting Mesalamine Formulations in Regions of the Human Gastrointestinal Tract.三种局部作用美沙拉嗪制剂在人体胃肠道区域的体内胃肠道释放和溶解测定
Mol Pharm. 2017 Feb 6;14(2):345-358. doi: 10.1021/acs.molpharmaceut.6b00641. Epub 2016 Dec 23.
5
Open Flow Microperfusion as a Dermal Pharmacokinetic Approach to Evaluate Topical Bioequivalence.开放流微灌注作为一种评估局部生物等效性的皮肤药代动力学方法。
Clin Pharmacokinet. 2017 Jan;56(1):91-98. doi: 10.1007/s40262-016-0442-z.
6
Validating Whole-Airway CFD Predictions of DPI Aerosol Deposition at Multiple Flow Rates.验证多流速下 DPI 气溶胶沉积的全气道 CFD 预测。
J Aerosol Med Pulm Drug Deliv. 2016 Dec;29(6):461-481. doi: 10.1089/jamp.2015.1281. Epub 2016 Apr 15.
7
Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK.基于生理的药代动力学（PBPK）模型在支持剂量选择中的应用：美国食品药品监督管理局（FDA）关于PBPK的公开研讨会报告
CPT Pharmacometrics Syst Pharmacol. 2015 Apr;4(4):226-30. doi: 10.1002/psp4.33. Epub 2015 Apr 17.

Current Scientific Considerations to Verify Physiologically-Based Pharmacokinetic Models and Their Implications for Locally Acting Products.

作者信息

Zhao Liang, Seo Paul, Lionberger Robert

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, Silver Spring, Maryland, USA.

Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

出版信息

CPT Pharmacometrics Syst Pharmacol. 2019 Jun;8(6):347-351. doi: 10.1002/psp4.12421.

DOI:10.1002/psp4.12421
PMID:31355547
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6662325/
Abstract
摘要