Yahoo Web Search

Search results

1. • • As the name suggests, MIE is an alternative model-based, data-analytical approach to the demonstration of BE. It integrates a number of different sources of data to model and predict BE.
     www.engage.hoganlovells.com › knowledgeservices › news

     FDA MIE pilot hints at expanding regulatory paradigm for ...

2. People also ask

   What is model-integrated evidence (Mie) for bioequivalence?

   • On October 1, 2023, FDA launched a new pilot offering meeting opportunities to prospective generic drug applicants and generic drug applicants who intend to use Model-Integrated Evidence (MIE) approaches for bioequivalence (BE) establishment in their abbreviated new drug applications (ANDAs).

   A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting

   www.fda.gov/drugs/news-events-human-drugs/deep-dive-fdas-model-integrated-evidence-mie-industry-meeting-pilot-program-generic-drugs-01182024

   See all results for this question

   Can Mie approaches be used for generic drug development?

   • Lanyan (Lucy) Fang, Deputy Director at the Division of Quantitative Methods and Modeling/Office of Research and Standards/Office of Generic Drugs, highlighted high-impact opportunity areas where MIE approaches can be used for BE evaluations, supporting generic drug development and regulatory approval.

   Experience Learned and Perspectives on Using Model ... - Springer

   link.springer.com/article/10.1208/s12248-023-00884-5

   See all results for this question

   Are Mie approaches enabling alternative study designs for long-acting injectable (Lai) products?

   • One important message from Dr. Lanyan (Lucy) Fang (US FDA) was that MIE approaches are being leveraged towards developing alternative study designs for long-acting injectable (LAI) products that involve shorter study durations and lower number of study participants and therefore alleviate relevant challenges for this type of products ( 2 ).

   Experience Learned and Perspectives on Using Model ... - Springer

   link.springer.com/article/10.1208/s12248-023-00884-5

   See all results for this question

   Can model-integrated evidence be used in long-acting injectable products?

   • The workshop attendees discussed that model-integrated evidence (MIE) approaches for generics are being applied in the space of long-acting injectable (LAI) products to develop shorter and more cost-effective alternative study designs for LAI products.

   Experience Learned and Perspectives on Using Model ... - Springer

   link.springer.com/article/10.1208/s12248-023-00884-5

   See all results for this question

3. www.fda.gov › media › 172028GENERAL PRINCIPLES MODEL-INTEGRATED EVIDENCE (MIE) INDUSTRY ...

   www.fda.gov › media › 172028

   Sep 12, 2023 · MODEL-INTEGRATED EVIDENCE (MIE) INDUSTRY MEETING PILOT BETWEEN ... focused interactions for science-driven topics using model-integrated evidence (MIE) approaches for bioequivalence (BE ...

   • Model-Integrated Evidence (MIE) Industry Meeting Pilot ...

     Prospective generic drug applicants and generic drug...

   • A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry ...

     On October 1, 2023, FDA launched a new pilot offering...

4. link.springer.com › article › 10Experience Learned and Perspectives on Using Model-Integrated ...

   link.springer.com › article › 10

   • Cached

   Jan 10, 2024 · Model-integrated evidence approach to inform an in silico bioequivalence study design at steady state for long-acting injectable products Full size image A smaller or underpowered PK BE study can be employed in an alternative design in which the PK data obtained is used to create and/or validate an existing PPK model, which is then used to ...

   • Author: Eleftheria Tsakalozou

5. ascpt.onlinelibrary.wiley.com › doi › 10Establishing the suitability of model‐integrated evidence to ...

   ascpt.onlinelibrary.wiley.com › doi › 10

   Jan 29, 2023 · Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop - Gong - 2023 - CPT: Pharmacometrics & Systems Pharmacology - Wiley Online Library.

6. www.engage.hoganlovells.com › knowledgeservicesFDA MIE pilot hints at expanding regulatory paradigm for ...

   www.engage.hoganlovells.com › knowledgeservices

   Oct 13, 2023 · 13 October 2023. The U.S. Food and Drug Administration (FDA) generic drug program has launched a new pilot program to offer meeting opportunities to generic drug applicants who intend to use model-integrated evidence (MIE) approaches to establish bioequivalence (BE) in their abbreviated new drug applications (ANDAs).

7. crcg.idfive.com › wp-content › uploadsGenerating Model-integrated Evidence for Developing and ...

   crcg.idfive.com › wp-content › uploads

   Nov 2, 2022 · Model-integrated evidence (MIE) refers to using model generated information such as the virtual bioequivalence (VBE) study results not just to plan a pivotal study but to serve as pivotal evidence www.fda.gov