Evidence map›Paper›PMID 36859342›Full record

ReviewTranslational psychiatry2023

Translatability of preclinical to early clinical tolerable and pharmacologically active dose ranges for central nervous system active drugs.

Guilherme S Ferreira, Francis M Dijkstra, Désirée H Veening-Griffioen, Wouter P C Boon, Huub Schellekens, Ellen H M Moors, Peter J K van Meer, Frederik E Stuurman, Joop M A van Gerven

Open access · goldAbstract readReview
In one paragraph

Review in Translational psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 28% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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

9 authors at 2 institutions in 1 country.

Guilherme S Ferreira *Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Francis M Dijkstra *Centre for Human Drug Research, Leiden, The Netherlands. fdijkstra@chdr.nl.ORCID 0000-0001-5804-0708
Désirée H Veening-GriffioenDepartment of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Wouter P C BoonCopernicus Institute of Sustainable Development, Innovation Studies, Utrecht University, Utrecht, The Netherlands.
Huub SchellekensDepartment of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Ellen H M MoorsCopernicus Institute of Sustainable Development, Innovation Studies, Utrecht University, Utrecht, The Netherlands.
Peter J K van MeerDepartment of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Frederik E StuurmanCentre for Human Drug Research, Leiden, The Netherlands.ORCID 0000-0002-0013-8355
Joop M A van GervenCentre for Human Drug Research, Leiden, The Netherlands.
Utrecht University · NLLeiden University Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The primary purpose of this study was to assess the translatability of preclinical to early clinical tolerable and pharmacologically active dose ranges for central nervous system (CNS) active drugs. As a part of this, IBs were reviewed on reporting quality. Investigator's Brochures (IBs) of studies performed at the Centre for Human Drug Research (CHDR) reporting statistically significant results of CNS activity related to the drug's mechanism of action were included. The quality of IBs was assessed based on the presence of a rationale for the chosen animal model, completeness of pharmacokinetic (PK) results in reporting and internal validity information of the preclinical evidence. The IB-derisk tool was used to generate preclinical and early clinical data overviews data. For each compound, the overlap between pharmacologically active dose ranges and well-tolerated levels was calculated for three pharmacokinetic (PK) parameters: human equivalent dose (HED), maximum plasma concentration (C

Indexed as

Central Nervous SystemAnimalsArea Under CurveHealthy VolunteersHumans

Identifiers

PMID36859342
PMCPMC9977891
OpenAlexW4322738896

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.