FDA Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Draft

标准简介

Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Draft[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于美国。

标准截图

 

标准文档说明

标准文档类型为Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Draft[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Draft — Not for Implementation 1 The Use of Physiologically Based Pharmacokinetic Analyses — 2 Biopharmaceutics Applications for Oral Drug Product 3 Development, Manufacturing Changes, and Controls 1

4 Guidance for Industry 5 6 7 8 9 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 10 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 11 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 12 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 13 for this guidance as listed on the title page. 14 15 16 17 18 I. INTRODUCTION 19 20 This guidance provides general recommendations regarding the development, evaluation, and 21 use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics 22 applications employed by sponsors of investigational new drug applications, and applicants for 23 new drug applications, or abbreviated new drug applications, and supplements to these 2,3

24 applications, for oral drug product development, manufacturing changes, and controls. PBPK 25 analyses use models and simulations that combine physiology, population, and drug substance 26 and product characteristics to mechanistically describe the pharmacokinetic (PK) and/or 4

27 pharmacodynamic behaviors of a drug product. 28 29 The application of PBPK modeling in support of drug product development is an evolving field. 30 We note that there are multiple terms used to describe PBPK analyses for biopharmaceutics 31 applications, including PBPK absorption modeling (Zhang et al. 2017), physiologically based 32 absorption modeling (Kesisoglou et al. 2016), and physiologically based biopharmaceutics 33 modeling (PBBM) (Heimbach et al. 2019). This guidance uses the term PBPK analyses (or 1

This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

For the purposes of this guidance, sponsor refers to sponsors of investigational new drug applications, applicants for new drug applications and abbreviated new drug applications, and supplements to those applications. 3

The scientific principles described in this guidance are applicable regardless of whether an original clinical study demonstrated bioavailability/bioequivalence and are relevant whether or not an application is required. 4

Submission of PBPK analyses to FDA is discussed in the guidance for industry Physiologically Based Pharmacokinetic Analyses — Format and Content (August 2018). We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-

information/search-fda-guidance-documents.

网盘链接

百度网盘：https://pan.baidu.com/s/1hzltKnvjuk2xKsK4p_SdLw
提取码：bipw