From: www.fda.gov
Food and Drug Administration (FDA) Office of Study Integrity and Surveillance, Office of Generic Drugs and Office of Clinical Pharmacology published a final guidance for industry entitled, “Evaluation of Internal Standard Responses during Chromatographic Bioanalysis: Questions and Answers". The guidance provides questions and answers on FDA’s current thinking on internal standard (IS) response variability in chromatographic analytical data, used to quantitate analyte concentrations in samples from nonclinical and clinical studies to support regulatory submissions.
ISs are commonly used in chromatographic analytical methods to correct for variability in sample processing and analysis. During bioanalysis, IS is added to samples including calibration standards, quality controls, and subject samples. IS response variability can include human errors made during sample preparation or processing, instrumental issues that may occur during analysis, and matrix effects.
The guidance explains when observed IS response variability may impact the accuracy of data and whether it warrants further investigation into the root causes. It also provides recommendations on addressing concerns about IS response variability.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.
