Pharmacometrics for regulatory decision making: status and perspective.

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

10 citing papers in PubMed.

1. Evaluation of the long-term durability and glycemic control of fasting plasma glucose and glycosylated hemoglobin for pioglitazone in Japanese patients with type 2 diabetes.Diabetes technology & therapeutics · 2015
   Trial
2. Editorial for the Special Issue "A Themed Issue in Honor of Professor Hartmut Derendorf-Outstanding Contributions in the Fields of Quantitative Clinical Pharmacology".Antibiotics (Basel, Switzerland) · 2023
   Article
3. Model Informed Drug Development and Regulation in China: Challenges and Opportunities.CPT: pharmacometrics & systems pharmacology · 2019
   Article
4. Applications of pharmacometrics in the clinical development and pharmacotherapy of anti-infectives.Expert review of clinical pharmacology · 2013
   Review
5. Regulatory modeling and simulation moves into the next gear in europe.CPT: pharmacometrics & systems pharmacology · 2013
   Article
6. Modeling and simulation to optimize the design and analysis of confirmatory trials, characterize risk-benefit, and support label claims.CPT: pharmacometrics & systems pharmacology · 2013
   Article
7. The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop.CPT: pharmacometrics & systems pharmacology · 2013
   Article
8. CPT: Pharmacometrics and Systems Pharmacology.CPT: pharmacometrics & systems pharmacology · 2012
   Article
9. Basic concepts in population modeling, simulation, and model-based drug development.CPT: pharmacometrics & systems pharmacology · 2012
   Article
10. Role of modelling and simulation: a European regulatory perspective.Clinical pharmacokinetics · 2012
    Review

Corrections and comments

• Comment on
  Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.2011

Authors and funding

2 authors.

Funding

No grant is acknowledged in the PubMed record.

Abstract

PubMed holds no abstract for this paper.

Indexed as