Evidence map›Paper›PMID 35094370›Full record

SynthesisDaru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences2022

Assessment of the predictive capability of modelling and simulation to determine bioequivalence of inhaled drugs: A systematic review.

Juliet Rebello, Bill Brashier, Sharvari Shukla

Open access · greenAbstract readSystematic Review
In one paragraph

Synthesis in Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 45% of its field
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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
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

3 authors at 2 institutions in 1 country.

Juliet RebelloClinical Research Division, Cipla Ltd, Mumbai, Maharashtra, India. juliet@cipla.com.ORCID http://orcid.org/0000-0002-4795-7657
Bill BrashierClinical Research Division, Cipla Ltd, Mumbai, Maharashtra, India.
Sharvari ShuklaSymbiosis Statistical Institute (SSI), Symbiosis International University, Pune, Maharashtra, India.ORCID http://orcid.org/0000-0002-7029-5532
Cipla (India) · INSymbiosis International University · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThere are a multitude of different modelling techniques that have been used for inhaled drugs. The main objective of this review was to conduct an exhaustive survey of published mathematical models in the area of asthma and chronic obstructive pulmonary disease (COPD) for inhalation drugs. Additionally, this review will attempt to assess the applicability of these models to assess bioequivalence (BE) of orally inhaled products (OIPs). EVIDENCE ACQUISITION: PubMed, Science Direct, Web of Science, and Scopus databases were searched from 1996 to 2020, to find studies that described mathematical models used for inhaled drugs in asthma/COPD.

results50 articles were finally included in this systematic review. This research identified 22 articles on in silico aerosol deposition models, 20 articles related to population pharmacokinetics and 8 articles on physiologically based pharmacokinetic modelling (PBPK) modelling for inhaled drugs in asthma/COPD. Among all the aerosol deposition models, computational fluid dynamics (CFD) simulations are more likely to predict regional aerosol deposition pattern in human respiratory tracts. Across the population PK articles, body weight, gender, age and smoking status were the most common covariates that were found to be significant. Further, limited published PBPK models reported approximately 29 parameters relevant for absorption and distribution of inhaled drugs. The strengths and weaknesses of each modelling technique has also been reviewed.

conclusionOverall, while there are different modelling techniques that have been used for inhaled drugs in asthma and COPD, there is very limited application of these models for assessment of bioequivalence of OIPs. This review also provides a ready reference of various parameters that have been considered in various models which will aid in evaluation if one model or hybrid in silico models need to be considered when assessing bioequivalence of OIPs.

Indexed as

AsthmaPulmonary Disease, Chronic ObstructiveAdministration, InhalationAerosolsComputer SimulationHumansModels, BiologicalTherapeutic EquivalencyAerosolsAsthma and COPDComputational fluid dynamicsInhalationPBPKPopulation pharmacokinetics

Identifiers

PMID35094370
PMCPMC9114201
OpenAlexW4210476726

What OpenQuestion holds

Textmetadata
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.