Evidence map›Paper›PMID 32297044›Full record

ArticleThe AAPS journal2020

Comparison of Alternative Population Modeling Approaches for Implementing a Level A IVIVC and for Assessing the Time-Scaling Factor Using Deconvolution and Convolution-Based Methods.

Roberto Gomeni, Françoise Bressolle-Gomeni

Abstract readComparative StudyValidation Study
PubMed Publisher
In one paragraph

Article in The AAPS journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. 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

2 authors.

Roberto GomeniR&D, Pharmacometrica, Lieu-dit Longcol, 12270, La Fouillade, France. roberto.gomeni@pharmacometrica.com.
Françoise Bressolle-GomeniR&D, Pharmacometrica, Lieu-dit Longcol, 12270, La Fouillade, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Different approaches based on deconvolution and convolution analyses have been proposed to establish IVIVC. A new implementation of the convolution-based model was used to evaluate the time-scaled IVIVC using the convolution (method 1) and the deconvolution-based (method 2) approaches. With the deconvolution-based approach, time-scaling was detected and estimated using Levy's plots while with the convolution-based approach, time-scaling was directly determined by a time-scaling sub-model of the convolution integral model by nonlinear regression. The objectives of this study were (i) to show how time-scaled deconvolution and convolution-based approaches can be implemented using population modeling approach using standard nonlinear mixed-effect modeling software such as NONMEM and R, and (ii) to compare the performances of the two methods for assessing IVIVC using complex in vivo drug release process. The impact of different PK scenarios (linear and nonlinear PK disposition models, and increasing levels of inter-individual variability (IIV) on in vivo drug release process) was considered. The performances of the methods were assessed by computing the prediction error (%PE) on C

Indexed as

Drug LiberationModels, Theoreticalconvolution-based IVIVCdeconvolution-based IVIVCNONMEMpopulation approachtime-scaling

Identifiers

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.