Evidence map›Paper›PMID 41199079›Full record

ReviewPharmaceutical research2025

Using Lung Regional Deposition Modeling as Model-Integrated Evidence for Locally Acting Orally Inhaled Drug Products.

Ross L Walenga, Steven G Chopski, Jae H Lee, Fenggong Wang, Meng Hu, Andrew H Babiskin, Lanyan Fang, Liang Zhao

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Pharmaceutical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Ross L WalengaDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Ross.Walenga@fda.hhs.gov.ORCID http://orcid.org/0000-0003-3261-4245
Steven G ChopskiDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Jae H LeeDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Fenggong WangDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Meng HuDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Andrew H BabiskinDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Lanyan FangDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Liang ZhaoDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Evaluation of drug delivery for locally acting orally inhaled drug products (OIDPs) is challenging because there are no routinely conducted studies that directly quantify drug concentration in specific regions of the human lungs. In vivo regional deposition studies are helpful for understanding region-specific drug delivery to the lungs but are limited by a variety of factors including small population samples, long study duration, and representation of results in two-dimensional rather than three-dimensional frameworks. Lung regional deposition modeling (RDM) can provide useful insights on region-specific drug delivery to the lungs for locally acting OIDPS because it can be used to understand many of the underlying physical processes that influence drug delivery, and it can be used to develop in vitro in vivo correlations. When RDM is combined with in vitro and/or in vivo data that serve as model validation comparators as well as sources for model parameter inputs, and model credibility is established, it may be considered model-integrated evidence (MIE) when it is used to facilitate generic locally acting OIDP development and approval and thereby improve accessibility of OIDPs.

Indexed as

Drug Delivery SystemsLungModels, BiologicalAdministration, InhalationAdministration, OralAnimalsHumansPharmaceutical PreparationsTissue DistributionPharmaceutical PreparationsComputational fluid dynamicsModel credibilityModel-integrated evidenceOrally inhaled drug productsRegional deposition modeling

Identifiers

PMID41199079
PMCPMC12611284

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.