FDA Guidance for Industry: Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers

FDA Guidance for Industry: Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers

This guidance provides recommendations to sponsors, applicants, and contract research 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