Should we tolerate tolerability as an objective in early drug development?

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.

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.

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

1. Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions.Drug safety · 2009
   Pooled it
2. A zwitterionic near-infrared fluorophore for real-time ureter identification during laparoscopic abdominopelvic surgery.Nature communications · 2019
   Trial
3. The acute effect of beta-guanidinopropionic acid versus creatine or placebo in healthy men (ABC-Trial): A randomized controlled first-in-human trial.British journal of clinical pharmacology · 2017
   Trial
4. Measuring the multidimensional aspects of tolerability.Cancer · 2025
   Review
5. Dose escalations in phase I studies: Feasibility of interpreting blinded pharmacodynamic data.British journal of clinical pharmacology · 2022
   Article
6. Goodbye to all that.British journal of clinical pharmacology · 2019
   Article
7. Pharmacological vs. classical approaches in the design of first in man clinical drug trials.British journal of clinical pharmacology · 2017
   Article
8. Implications of the BIA-102474-101 study for review of first-into-human clinical trials.British journal of clinical pharmacology · 2016
   Article
9. The return of the prodigal son and the extraordinary development route of antibody TGN1412 - lessons for drug development and clinical pharmacology.British journal of clinical pharmacology · 2015
   Article
10. Developing drug prototypes: pharmacology replaces safety and tolerability?Nature reviews. Drug discovery · 2010
    Review
11. Testing new drugs in naked apes and getting the dose right in their young.British journal of clinical pharmacology · 2010
    Article
12. Risk assessment in extrapolation of pharmacokinetics from preclinical data to humans.Clinical pharmacokinetics · 2010
    Article
13. Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics.British journal of clinical pharmacology · 2009
    Article

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

Authors and funding

1 author.

Funding

No grant is acknowledged in the PubMed record.

Abstract

PubMed holds no abstract for this paper.

Indexed as