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FDA Bioanalytical Method Validation Guidance for Industry

蒋千琴 11/6/2021 浏览 142 FDA United States

标准简介

Bioanalytical Method Validation Guidance for Industry[附网盘链接]是于不久前发布的FDA标准，适用于United States。

标准截图

Bioanalytical Method Validation Guidance for Industry[附网盘链接]
Bioanalytical Method Validation Guidance for Industry[附网盘链接](截图)

 

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标准文档类型为Bioanalytical Method Validation Guidance for Industry[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

Bioanalytical Method Validation 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance helps sponsors of investigational new drug applications (INDs) or applicants of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements validate bioanalytical methods used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies that require 2

pharmacokinetic, toxicokinetic, or biomarker concentration evaluation. This guidance can also inform the development of bioanalytical methods used for nonclinical studies that require toxicokinetic or biomarker concentration data. For studies related to the veterinary drug approval process such as investigational new animal drug applications (INADs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs), this guidance may apply to blood and urine BA, BE, and pharmacokinetic studies. The information in this guidance applies to bioanalytical procedures such as chromatographic assays (CCs) and ligand binding assays (LBAs) that quantitatively determine the levels of drugs, their metabolites, therapeutic proteins, and biomarkers in biological matrices such as blood, serum, plasma, urine, and tissue such as skin. This final guidance incorporates public comments to the revised draft published in 2013 and provides recommendations for the development, validation, and in-study use of bioanalytical methods. The recommendations can be modified with justification, depending on the specific type of bioanalytical method. This guidance reflects advances in science and technology related to validating bioanalytical methods. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 1

This guidance has been prepared by the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research and the Center for Veterinary Medicine at the Food and Drug Administration. 2

This guidance applies to both sponsors and applicants. The use of the word sponsor applies to both sponsors and applicants and hence, INDs, NDAs, BLAs, and ANDAs. Bioanalytical Method Validation 1

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