To ensure data supporting regulatory decisions are reliable by conducting and directing inspections of bioavailability/bioequivalence (BA/BE) and nonclinical (GLP) studies submitted to FDA.
OSIS staff support FDA's mission to protect the public health by:
- Conducting comprehensive study-directed and surveillance inspections of firms that conduct pharmacokinetic, bioavailability/bioequivalence (BA/BE), Good Laboratory Practice (GLP), and Animal Rule (AR) studies in support of human drug applications.
- Developing and refining strategies to improve inspection planning, execution, evaluation, and provide recommendations to CDER review divisions, while focusing on human subject safety and data integrity.
- Conducting outreach through participation in national and international conferences and workshops, and collaborating with international regulatory agencies by conducting joint inspections, observed inspections, and shared training.
Office Director: Sean Kassim, PhD
Deputy Office Director: Vacant
Division of New Drug Study Integrity
Division Director: Chuck Bonapace, PharmD
Deputy Division Director: Arindam Dasgupta, PhD
Division of Generic Drug Study Integrity
Division Director: Seongeun Cho, PhD
Deputy Division Director: John Kadavil, PhD
- Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance.
- Welink, Jan, et al. "2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1-small molecules by LCMS)." Bioanalysis 7.22 (2015): 2913-2925.
- Ackermann B et al., 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies). Bioanalysis. 2015 Dec;7(23):3019-34. doi: 10.4155/bio.15.214. Epub 2015 Dec 2.
- Amaravadi, Lakshmi, et al. "2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3-LBA, biomarkers and immunogenicity)." Bioanalysis 7.24 (2015): 3107-3124.
- Vaithianathan, Soundarya, et al. "Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir." Journal of pharmaceutical sciences (2015).
For more information, please contact the Office of Study Integrity and Surveillance.