ReviewCPT: pharmacometrics & systems pharmacology2023
Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop.
Review in CPT: pharmacometrics & systems pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed.
- Model-Integrated Bioequivalence (MIBE) in Generic Drug Research: Can We Ease the Bioequivalence Burden?Pharmaceutics · 2026Review
- Leveraging Model Integrated Bioequivalence (MIBE) to Address Regulatory Concerns and Waive Repeat Bioequivalence Studies-A Case Study with Clopidogrel.Journal of clinical pharmacology · 2026Article
- An Open-Source Framework for Virtual Bioequivalence Modeling and Clinical Trial Design.CPT: pharmacometrics & systems pharmacology · 2025Article
- Impact of Mechanistic Modeling and Simulation Methodologies on Product-Specific Guidance Development for Non-Orally Administered Drug Products.CPT: pharmacometrics & systems pharmacology · 2025Review
- Leveraging Model Master Files for Long-Acting Injectables.Pharmaceutical research · 2025Article
- Considering Opportunities and Challenges When Implementing the Model Master File Framework - a Meeting Report.Pharmaceutical research · 2025Article
- Challenges for switching central nervous system and psychiatric medication products: A review of the literature.Journal of psychopharmacology (Oxford, England) · 2025Review
- Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023.The AAPS journal · 2024Article
- Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products-a Meeting Report.The AAPS journal · 2024Article
- A Bayesian framework for virtual comparative trials and bioequivalence assessments.Frontiers in pharmacology · 2024Article
- Advances in quantitative methods and modeling for complex generic drugs and opportunities to hybridize learnings between innovator and generic drug developers.CPT: pharmacometrics & systems pharmacology · 2023Article
- Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop.CPT: pharmacometrics & systems pharmacology · 2023Review
- Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery.CPT: pharmacometrics & systems pharmacology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
Abstract
On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled "Establishing the Suitability of Model-Integrated Evidence (MIE) to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable (LAI) Drug Products." This workshop brought relevant parties from the industry, academia, and the FDA in the field of modeling and simulation to explore, identify, and recommend best practices on utilizing MIE for bioequivalence (BE) assessment of LAI products. This report summerized presentations and panel discussions for topics including challenges and opportunities in development and assessment of generic LAI products, current status of utilizing MIE, recent research progress of utilizing MIE in generic LAI products, alternative designs for BE studies of LAI products, and model validation/verification strategies associated with different types of MIE approaches.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.