FDA Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification
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Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification[附网盘链接]由FDA于当前发布，适用于United States。标准截图
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标准文档类型为Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification[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
Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification 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 2
This guidance is intended to assist submitters of a biomarker for qualification that conduct nonclinical studies for which histopathology is used as a reference or truth standard (Zhou et al. 2011). Scientifically rigorous evaluation of biomarker performance in relation to histopathologic changes is essential in these studies because they may provide direct evidence to support nonclinical biomarker qualification or supportive translational data to aid in the development and qualification of clinical biomarkers for a proposed context of use. This guidance discusses the issues that should be considered when generating histopathology data in nonclinical biomarker qualification studies and outlines the scientific standards recommended for biomarker characterization and qualification. The biomarker qualification process is 3
described in a separate guidance, Qualification Process for Drug Development Tools. 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 as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 1
This guidance has been prepared by the Office of New Drugs and the Office of Translational Sciences in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. 2
Terms that appear in bold type upon first use are defined in the Glossary section of this guidance. 3
See FDA guidance for industry and FDA staff on Qualification Process for Drug Development Tools, available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 1
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