FY2016 Regulatory Science Report: Pharmacokinetic/Pharmacodynamic Models and Pharmacometrics
This section contains only new information from FY2016. For background scientific information and outcomes from previous years on this research topic, please refer to the FY15 Regulatory Science Research Report on Pharmacokinetic/Pharmacodynamic Models and Pharmacometrics.
ORS staff facilitating research in this area
- Lanyan Fang, Hyewon Kim, Zhichuan Li, Mario Gonzalez Sales, Jia Chen, Elin Matsson, Vittal Shivva, Yehua Xie, Andrew Babiskin, and other ORS members
Projects and Collaborators
- Population pharmacokinetic and pharmacodynamic, dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs
- Site PI: Jogarao V Gobburu
- Grant #: 1U01FD005188-01
- Pharmacometric modeling and simulation for a generic drug substitutability evaluation and post marketing risk assessment
- Site PI: Jogarao V Gobburu
- Grant #: 1U01FD005192-01
- A model- and systems-based approach to efficacy and safety questions related to generic substitution
- Site PI: Lawrence Lesko
- Grant #: 1U01FD005210-01
- Pharmacometric modeling of immunosuppressants for evaluation of bioequivalence criteria
- Site PI: Catherine Mary Turner Sherwin
- Grant #: 1U01FD005191-01
- Collection of dose adjustment and therapeutic monitoring data to aid narrow therapeutic index drug classification
- Site PI: Michael Cohen-Wolkowiez
- Grant #: 1U01FD004858-01
- Data-fusion based platform development of population PKPD modeling and statistical analysis for bioequivalence assessment of long-acting injectable products
- Site PI: Seongkyu Yoon
- Grant #: 5U01FD005444-02
- Pharmacometric Modeling and Simulation for Evaluation of Bioequivalence for Leuprolide Acetate Injection
- Site PI: Catherine Mary Turner Sherwin
- 5U01FD005442-02
Publications and Presentations
- Shivva V, Fang L, Yang X, Zheng N, Zhu H, Raney SG, Kim MJ, Zhao L. Use of a Model Based Approach for Evaluation of partial Area Under the Curve for Bioequivalence Assessment of Methylphenidate Transdermal products. American Conference on Pharmacometrics (ACoP7) Annual Meeting, Seattle WA (Oct 23-26, 2016)
- Shivva V, Qin M, Wen H, Kim MJ, Zhao L, Fang L. Assessment of Pharmacokinetic Profile Similarity in Bioequivalence Evaluation for Quetiapine fumarate extended release tablets. AAPS Annual Meeting, Denver, CO (Nov 13-17, 2016)
- Chen J, Fang L, Pu X, Wang Y, Pan Y, Lu D, Jiang X, Stier E, Li BV, Zhao L. Methodology advancement on dose-scale analysis to assess pharmacodynamics equivalence. ACoP7 Annual Meeting, Seattle WA (Oct 23-26, 2016).
Outcomes
- Revision of Draft product-specific guidance on Methylphenidate transdermal extended release film (Oct 2016).
- Nine completed consults for ANDA reviews with PKPD modeling analysis
- Seventeen product-specific guidances that utilized PKPD modeling analysis
- Two pre-ANDA meetings with industry with PKPD modeling analysis
- One Citizen Petition response with PKPD modeling analysis