Evidence map›Paper›PMID 7867672›Full record

ArticleEuropean journal of drug metabolism and pharmacokinetics

Are we doing too many animal biodisposition investigations before phase I studies in man? A re-evaluation of the timing and extent of ADME studies.

D B Campbell

Abstract read
PubMed Publisher
In one paragraph

Article in European journal of drug metabolism and pharmacokinetics. 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
–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

2 citing papers in PubMed.

  1. Article
  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

1 author.

D B CampbellServier Research & Development, Fulmer, Slough, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This commentary attempts to re-evaluate, from a scientific standpoint, the timing and usefulness of undertaking detailed kinetic and metabolic studies in many animals from several species, and extrapolating the findings to man. This reappraisal is now possible due to the conditional acceptance of harmonised guidelines on toxicokinetics at ICH2 in Orlando in 1993, the results from which can provide much of the information that is required to design and validate safety studies and to extrapolate exposure or safety margins to man.

Indexed as

PharmacokineticsAnimalsClinical Trials, Phase I as TopicCytochrome P-450 Enzyme SystemHumansProtein BindingTime FactorsCytochrome P-450 Enzyme System

Identifiers

PMID7867672

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.