Summary report of second EUFEPS/AAPS conference on global harmonization in bioequivalence

Chen, Mei‐Ling; Blume, Henning; Beuerle, Gerald; Mehta, Mehul; Potthast, Henrike; Brandt, Andreas; Schug, Barbara; Ducharme, Murray P.; Endrényi, László; Gallicano, Keith; Schuirmann, Donald J.; Welink, Jan

doi:10.1016/j.ejps.2018.10.019

Cited by 12 publications

(1 citation statement)

References 17 publications

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“…Two case studies were presented on the expansion potential of model‐informed BE by Dr Bhoopathy. The first case study was on the use of novel in vitro input parameters from a combined dissolution and absorption system to justify wider tolerance of excipient differences for BCS class 3 biowaivers, 16 which are currently applied during the investigational new drugs / new drug applications or abbreviated new drug applications. The work, which is currently ongoing, is divided into two phases.…”

Section: Meeting Summarymentioning

confidence: 99%

Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model‐Based Bioequivalence

Lee

Gong

Bhoopathy

et al. 2020

Clin Pharma and Therapeutics

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On May 4, 2020, the US Food and Drug Administration (FDA) hosted an online public workshop titled "FY 2020 Generic Drug Regulatory Science Initiatives Public Workshop" to provide an overview of the status of the science and research priorities and to solicit input on the development of Generic Drug User Fee Amendments fiscal year 2021 priorities. This report summarizes the podium presentations and the outcome of discussions along with innovative ways to overcome challenges and significant opportunities related to model-based approaches in bioequivalence assessment for breakout session 4 titled, "Data analysis and model-based bioequivalence (BE)." This session focused on the application of model-based approaches in the generic drug development, with a vision of accelerating regulatory decision making for abbreviated new drug application assessments. The session included both podium presentations and panel discussions with three topics of interest: (i) in vitro study evaluation methods and their clinical relevance, (ii) challenges in model-based BE, (iii) emerging expertise and tools in implementing new BE approaches.

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Section: Meeting Summarymentioning

confidence: 99%