Evidence map›Paper›PMID 30659771›Full record

ArticleCPT: pharmacometrics & systems pharmacology2019

A General Framework for Assessing In vitro/In vivo Correlation as a Tool for Maximizing the Benefit-Risk Ratio of a Treatment Using a Convolution-Based Modeling Approach.

Roberto Gomeni, Lanyan Lucy Fang, Françoise Bressolle-Gomeni, Thomas J Spencer, Stephen V Faraone, Andrew Babiskin

Abstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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

6 authors.

Roberto GomeniPharmacometrica, La Fouillade, France.ORCID 0000-0003-3916-9578
Lanyan Lucy FangDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Françoise Bressolle-GomeniPharmacometrica, La Fouillade, France.
Thomas J SpencerMassachusetts General Hospital, Boston, Massachusetts, USA.
Stephen V FaraoneSUNY Upstate Medical University, Syracuse, New York, USA.
Andrew BabiskinDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Funding

Pharmacokinetic Pharmacodynamic Studies of Methylphenidate Extended Release Products in Pediatric Attention Deficit Hyperactivity DisorderU01FD005240 · FDA · MASSACHUSETTS GENERAL HOSPITAL · PI SPENCER, THOMAS J · 2014 to 2019
$3.9M
FDA HHS U01 FD005240
6 · The paper itself

Abstract

The net benefit of a treatment can be defined by the relationship between clinical improvement and risk of adverse events: the benefit-risk ratio. The optimization of the benefit-risk ratio can be achieved by identifying the most adequate dose (and/or dosage regimen) jointly with the best-performing in vivo release properties of a drug. A general in silico tool is presented for identifying the dose, the in vitro and the in vivo release properties that maximize the benefit-risk ratio using convolution-based modeling, an exposure-response model, and a surface response analysis. A case study is presented to illustrate how the benefit-risk ratio of methylphenidate for the treatment of attention deficit hyperactivity disorder can be maximized using the proposed strategy. The results of the analysis identified the characteristics of an optimized dose and in vitro/in vivo release suitable to provide a sustained clinical response with respect to the conventional dosage regimen and formulations.

Indexed as

AlgorithmsAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsCross-Over StudiesDose-Response Relationship, DrugDrug Dosage CalculationsHumansIn Vitro TechniquesMethylphenidateModels, TheoreticalOdds RatioRandomized Controlled Trials as TopicTreatment OutcomeCentral Nervous System StimulantsMethylphenidate

Identifiers

PMID30659771
PMCPMC6389349

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.