A schedule of events for Questioning the Bioequivalence Standards for Antiepileptic Drugs: Implications for Regulation of Narrow Therapeutic Index Drugs is provided below for your convenience.
For a printer-friendly version the agenda, please download the conference brochure. Conference sessions will include the following focus areas:
- Assess the emerging data, including case evidence and post-marketing surveillance (e.g., MedWatch) to see if it suggests that patients with epilepsy may have issues of tolerability for generic AED switching.
- Review data from ANDA submissions to survey average differences in the rate and extent of drug absorption between generic and innovator products including a comparison of immediate and modified release product performance.
- Establish criteria for an AED to be considered a NTI drug based on efficacy and toxicity profiles with consideration of within-patient variability, therapeutic drug monitoring, clinical dose adjustment, and others.
- Review preliminary results and conclusions from current single- and multiple-dose AED bioequivalence trials of brand and generic lamotrigine tablets in epilepsy patients
- Present an ongoing investigation of the potential to extrapolate efficacy of anti-epileptics for treating partial seizures in adults to pediatrics.
Moderators: TBD
| Time | Activity |
|---|---|
| 9:00-9:15 a.m. | Opening Remarks Janet Woodcock, MD Director, Center for Drug Evaluation and Research Food and Drug Administration |
| 9:15-9:45 a.m. | Results of Bioequivalence in Epilepsy Patients (BEEP) Study James Polli, PhD Shangraw/Noxell Endowed Chair in Industrial Pharmaceutics Co-Principal Investigator, M-CERSI University of Maryland School of Pharmacy Tricia Ting, MD Associate Professor of Neurology University of Maryland School of Medicine |
| 9:45-10:15 a.m. | Equivalence Among Generic AEDs (EQUIGEN) Study Michel Berg, MD Associate Professor of Neurology University of Rochester School of Medicine and Dentistry |
| 10:15-10:45 a.m. | Ensuring Safety and Efficacy of Generic Anti-Epileptic Drugs: FDA OGD Perspectives Wenlei Jiang, PhD Pharmacologist Science Staff Office of Generic Drugs Food and Drug Administration |
| 10:45-11:00 a.m. | Break |
| 11:00-11:30 a.m. | Physician Practices and Implications for NTI Classification William Clarke, PhD Associate Professor of Pathology Johns Hopkins University Michael Cohen-Wolkowiez, MD Associate Professor of Pediatrics Duke University School of Medicine |
| 11:30-12:00 p.m. | Panel Discussion Panelists will include:
|
| 12:00-1:00 p.m. | Lunch |
| 1:00-1:30 p.m. | Dose Sensitivity Considerations for AEDs James Cloyd, PharmD Professor of Experimental and Clinical Pharmacology University of Minnesota College of Pharmacy |
| 1:30-2:00 p.m. | Industrial Perspective: NTI Considerations in Ongoing Product Quality Jack Cook, PhD Vice President, Clinical Pharmacology Specialty Care Pfizer, Inc. |
| 2:00-2:30 p.m. | Extrapolating Efficacy of AEDs from Adults to Pediatrics: An Ongoing Critical Path Project Angela Men, MD, PhD Clinical Pharmacology Team Leader for Neurology Products Food and Drug Administration |
| 2:30-2:45 | Break |
| 2:45-3:15 | Modified Release AED Generic Standards Gregory Krauss, MD Professor of Neurology Johns Hopkins University School of Medicine |
| 3:15-3:45 | Panel Discussion Panelists will include:
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| 3:45-4:00 p.m. | Closing Remarks Robert Lionberger, PhD Acting Deputy Director for Science Office of Generic Drugs Food and Drug Administration |