FDA发布口服药品开发、生产变更与控制中PBPK分析应用指南草案
The Use of Physiologically Based Pharmacokinetic Analyses—Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls
FDA发布一份草案指南，就口服药品开发、生产变更与控制中PBPK（基于生理的药代动力学）分析在生物药剂学申报中的应用提出一般性建议。该文件为Level 1草案，注明不用于实施、仅含非约束性建议，适用于IND申办方及NDA、ANDA和其补充申请的申请人。文件卷宗编号为FDA-2020-D-1517，公众可随时按21 CFR 10.115(g)(5)在线或书面提交意见。
草案就PBPK分析在口服药品生物药剂学申报中的应用给出一般性建议，可帮助读者了解其适用范围与征求意见安排。
GUIDANCE DOCUMENT
Draft Level 1 Guidance
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2020-D-1517
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides general recommendations regarding the development, evaluation, and use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications employed by sponsors of investigational new drug applications, and applicants for new drug applications, or abbreviated new drug applications, and supplements to these applications, for oral drug product development, manufacturing changes, and controls. PBPK analyses use models and simulations that combine physiology, population, and drug substance and product characteristics to mechanistically describe the pharmacokinetic (PK) and/or pharmacodynamic behaviors of a drug product.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1517.
来源：FDA Pharmaceutical Quality Documents · fda.gov