Evidence map›Paper›PMID 21762205›Full record

ArticleBritish journal of clinical pharmacology2012

Prediction of a potentially effective dose in humans for BAY 60-5521, a potent inhibitor of cholesteryl ester transfer protein (CETP) by allometric species scaling and combined pharmacodynamic and physiologically-based pharmacokinetic modelling.

Olaf Weber, Stefan Willmann, Hilmar Bischoff, Volkhart Li, Alexandros Vakalopoulos, Klemens Lustig, Frank-Thorsten Hafner, Roland Heinig, Carsten Schmeck, Klaus Buehner

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2012. 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
0.8field-weighted citation impact, top 27% 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

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Editors' pick 2012.British journal of clinical pharmacology · 2013
    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

10 authors at 2 institutions in 2 countries.

Olaf WeberBayer HealthCare AG, Bayer HealthCare Pharmaceuticals Global Drug Discovery, Wuppertal, Germany. olaf.weber@bayer.com
Stefan Willmann
Hilmar Bischoff
Volkhart Li
Alexandros Vakalopoulos
Klemens Lustig
Frank-Thorsten Hafner
Roland Heinig
Carsten Schmeck
Klaus Buehner
Bayer (Germany) · DEBayer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe purpose of this work was to support the prediction of a potentially effective dose for the CETP-inhibitor, BAY 60-5521, in humans.

methodsA combination of allometric scaling of the pharmacokinetics of the CETP-inhibitor BAY 60-5521 with pharmacodynamic studies in CETP-transgenic mice and in human plasma with physiologically-based pharmacokinetic (PBPK) modelling was used to support the selection of the first-in-man dose.

resultsThe PBPK approach predicts a greater extent of distribution for BAY 60-5521 in humans compared with the allometric scaling method as reflected by a larger predicted volume of distribution and longer elimination half-life. The combined approach led to an estimate of a potentially effective dose for BAY 60-5521 of 51 mg in humans.

conclusionThe approach described in this paper supported the prediction of a potentially effective dose for the CETP-inhibitor BAY 60-5521 in humans. Confirmation of the dose estimate was obtained in a first-in-man study.

Indexed as

Models, BiologicalAnimalsBiometryCholesterol Ester Transfer ProteinsDogsDose-Response Relationship, DrugFemaleHumansHydroxyquinolinesMaleMiceMice, TransgenicRatsRats, WistarBAY 60-5521Cholesterol Ester Transfer ProteinsHydroxyquinolines

Identifiers

PMID21762205
PMCPMC3269581
OpenAlexW1600625451

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.