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Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) September 2019 Biopharmaceutics Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) September 2019 Biopharmaceutics Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION 1 II. QUESTIONS AND ANSWERS 2 i Contains Nonbinding Recommendations Evaluation of Internal Standard Responses during Chromatographic Bioanalysis: Questions an