U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Generic Drug User Fee Amendments
  5. FY2016 Regulatory Science Report: Modified Release Drug Products: Therapeutic Equivalence between Brand-Name Drugs and Generics
  1. FDA User Fee Programs

FY2016 Regulatory Science Report: Modified Release Drug Products: Therapeutic Equivalence between Brand-Name Drugs and Generics

FY2016 Regulatory Science Report: Modified Release Drug Products: Therapeutic Equivalence between Brand-Name Drugs and Generics

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 Modified Release Drug Products: Therapeutic Equivalence between Brand-Name Drugs and Generics.

ORS staff facilitating research in this area

  • Hong Wen, Lanyan Fang, Xinyuan Zhang, Andrew Babiskin, Zhichuan Li, Sarah Dutcher, Hyewon Kim, Dajun Sun, and other ORS staff members

Projects and Collaborators

  • Evaluation of formulation dependence of drug-drug interaction with proton pump inhibitors (PPIs) for oral extended-release drug products
    • Site PI: David Moreton
    • Contract #: HHSF223201610004I
  • Bioequivalence study of lamotrigine extended release tablets in healthy subjects
    • Site PI: Bradley Vince
    • Contract #: HHSF223201210030I
  • Comparative surveillance of generic drugs by machine learning (AED drugs)
    • Site PI: Peggy Peissig
    • Contract #: HHSF223201510112C
  • BE and characterization of generic drugs (methylphenidate)
    • Site PI: Bradley Vince
    • Contract #: HHSF223201210030I, HHSF22301001T
  • Open-labeled pharmacokinetic and pharmacodynamic (PK-PD) studies of Metoprolol ER
    • Site PI: Larisa Cavallari
    • Grant #: 1U01FD005235-01
  • Bioequivalence and clinical effects of generic and brand Bupropion
    • Site PI: Evan Kharasch
    • Grant #: 1U01FD004899-01
  • A pharmacokinetic/pharmacodynamic study of methylphenidate formulations in pediatric attention-deficit/hyperactivity disorder (ADHD) patients in a laboratory classroom
    • Site PI: Thomas Spencer
    • Grant #: 1U01FD005240-01
  • Internal Project: Dissolution testing and other in vitro analysis of marketed MR drug products
    • FDA Collaborator: Zongming Gao, John Kauffman
    • FDA Center/Office/Division: CDER/OPQ/OTR/DPA

Publications and Presentations 

  • Sun D, Wen H, Externbrink A, Gao Z, Keire D, Krauss G, Jiang W. Intact Levetiracetam Extended-Release Tablets after Dissolution. AES Annual Meeting, Houston TX (Dec 2016)
  • Chow E, Zheng N, Qu W, Sun D, Wen H, Zhang X, Jiang W, Zhao L. Bioequivalence Analysis of Lamotrigine Extended-Release Tablets based on an In Vitro-In Vivo Relationship (IVIVR) Using the Physiologically Based Pharmacokinetic (PBPK) Absorption Model. AES Annual Meeting, Houston TX (Dec 2016)
  • Li Z, Zheng N, Wen H, Zhang X, Sun D, Chow E, Kinjo M, Zhao L, Jiang W. Bioequivalence Assessment of Brand and Generic Lamotrigine Extended-Release Tablets. AES Annual Meeting, Houston TX (Dec 2016)
  • Wen H, Sun D, Zhang X, Fan J, Fang L, Dutcher S, Babiskin A, Zhao L, Jiang W, Lionberger R. Brand-to-Generic Therapeutic Equivalence Analysis of Modified-Release (MR) Oral Drug Products. AAPS Annual Meeting and Exposition, Denver CO (Nov 2016)
  • Qin M, Sun D, Hoover A, Wokovich A, Guo C, Cui M, Zhao L, Wen H. Comparative In Vitro Studies of Generic Drug Products with Enteral Tube Feeding Administration. AAPS Annual Meeting and Exposition, Denver CO (Nov 2016)
  • Zhou T, Chow E, Wen H, Jiang W, Zhao L, Zhang X. Evaluation of the Impact of In Vitro Release Alterations on Pharmacokinetics of Metoprolol Succinate Extended-Release (ER) Tablets Using the Physiologically Based Pharmacokinetic (PBPK) Absorption Model. AAPS Annual Meeting and Exposition, Denver CO (Nov 2016)
  • Shivva V, Qin M, Wen H, Zhao L, Fang L. Assessment of Pharmacokinetic Profile Similarity in Bioequivalence Evaluation for Quetiapine Fumerate Extended Release Tablets. AAPS Annual Meeting and Exposition, Denver CO (Nov 2016)
  • Gao Z, Ngo CD, Ye W, Keire D, Sun D, Wen H, Jiang W. In Vitro Dissolution Testing of Nifedipine Extended-Release Tablets. AAPS Annual Meeting and Exposition, Denver CO (Nov 2016)
  • Lin H, Sun D, Zhang X, Wen H. Brand-Generic Substitutability Analysis of Venlafaxine Hydrochloride Extended-Release Tablets Based on Openable Matrix and Osmotic Pump Using PBPK Modeling and Simulation. AAPS Annual Meeting and Exposition, Denver CO (Nov 2016)
  • Tsakalozou E, Sun D, Wen H, Zhang X. In Vitro/In Vivo Relationship Development for Oxybutynin Chloride Extended-Release Tablets to Assess Bioequivalence. AAPS Annual Meeting and Exposition, Denver CO (Nov 2016)
  • Hoover A, Sun D, Wen H, Jiang W, Cui M, Keire D, Guo C. Developing Analytical Methods for In Vitro Comparative Nasogastric (NG) Tube Studies of Esomeprazole Magnesium Delayed Release Capsules. CRS Annual Meeting, Seattle WA (Jul 2016)
  • Lin H, Sun D, Zhang X, Wen H. Physiologically Based Pharmacokinetic Modeling for Substitutability Analysis of Venlafaxine Hydrochloride Extended-Release Formulations Using Different Release Mechanisms: Osmotic Pump versus Openable Matrix. Journal of Pharmaceutical Sciences, 105 (10), 3088-3096 (2016)
  • Sun D, Wen H, Externbrink A, Gao Z, Kauffman J, Buhse L, Krauss G, Lionberger R, Jiang W. Ghost-Pill-Buster: A Case Study of Intact Levetiracetam Extended-Release Tablets in Feces. CNS Drugs, 30(5), 455-460 (2016)
  • Hoover A, Sun D, Wen H, Jiang W, Cui M, Keire D, Guo C. Developing Analytical Methods for In Vitro Comparative Nasogastric (NG) Tube Studies of Esomeprazole Magnesium Delayed Release Capsules. AAPS Annual Meeting and Exposition, Orlando FL (Oct 2015)
  • Externbrink A, Jiang W, Wen H, Gao Z. Dissolution testing of extended release matrix tablets in compendial and biorelevant media. AAPS Annual Meeting and Exposition, Orlando FL (Oct 2015)

Outcomes

  • Evaluated the necessity of pAUC for multiple MR drug products and updated product specific guidances when needed
  • Contributed to BE reviews and approval of MR drug product ANDAs

ResourcesForYou