ReviewCPT: pharmacometrics & systems pharmacology2023
Mechanistic modeling of generic orally inhaled drug products: A workshop summary report.
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 7 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
7 citing papers in PubMed.
- Direct Numerical Simulations of Inhalation in a 23-Generation Lung Model.International journal for numerical methods in biomedical engineering · 2026Article
- A Critical Analysis of the CFD-DEM Simulation of Pharmaceutical Aerosols Deposition in Upper Intra-Thoracic Airways: Considerations on Aerosol Transport and Deposition.Pharmaceutics · 2024Article
- Sensitivity Analysis and Uncertainty Quantification of Nanoparticle Deposition from Tongue Morphological Variations.Life (Basel, Switzerland) · 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
- 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
- Mechanistic modeling of generic orally inhaled drug products: A workshop summary report.CPT: pharmacometrics & systems pharmacology · 2023Review
- Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview.CPT: pharmacometrics & systems pharmacology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In silico mechanistic modeling approaches have been designed by various stakeholders with the goal of supporting development and approval of generic orally inhaled drug products in the United States. This review summarizes the presentations and panel discussion that comprised a workshop session concentrated on the use of in silico models to predict various outcomes following orally inhaled drug product administration, including the status of such models and how model credibility may be effectively established.
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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.