FDA Evaluation of Internal Standard Responses During Chromatographic Bioanalysis Questions and Answers

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Evaluation of Internal Standard Responses During Chromatographic Bioanalysis Questions and Answers[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于United States。

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Evaluation of Internal Standard Responses during Chromatographic Bioanalysis: Questions and Answers 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 provides recommendations to sponsors, applicants, and contract research 2

organizations regarding internal standard (IS) response variability in chromatographic analytical data submitted in investigational new drug applications, new drug applications, abbreviated new drug applications, biologics license applications, and supplements. Chromatographic analytical methods are commonly used to quantitate analyte concentrations in samples from nonclinical and clinical studies to support regulatory submissions. Depending upon its source, IS response variability may impact the accuracy of analyte concentration measurements. This question and answer (Q&A) document provides the Agency’s current thinking on IS response variability and its potential impact on the accuracy of analyte concentration measurements. This Q&A also suggests approaches to determine whether observed IS response variability is likely to impact the accuracy of the data such that further investigation into the root cause(s) is warranted. 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 Study Integrity and Surveillance, the Office of Generic Drugs, and the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research at the Food and Drug Administration. You may submit comments on this guidance at any time. Submit comments to Docket No. FDA-

2017-D-6821 (available at https://www.regulations.gov/docket?D=FDA-2017-D-6821). See the instructions in that docket for submitting comments on this and other Level 2 guidances. 2

An IS response is a measurement of the signal from the IS, which is typically generated during liquid chromatography-mass spectrometry bioanalysis.

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