Evidence map›Paper›PMID 26616152›Full record

ReviewPharmacogenomics2015

The role of ADME pharmacogenomics in early clinical trials: perspective of the Industry Pharmacogenomics Working Group (I-PWG).

Larry Tremaine, William Brian, Terrye DelMonte, Stephan Francke, Peter Groenen, Keith Johnson, Lei Li, Kimberly Pearson, Jean-Claude Marshall

Abstract readReview
In one paragraph

Review in Pharmacogenomics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Drug Design: Where We Are and Future Prospects.Molecules (Basel, Switzerland) · 2021
    Review
  11. Article
  12. Review
  13. Review
  14. Leveraging Genomic Factors to Improve Benefit-Risk.Clinical and translational science · 2017
    Review
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.

Larry TremainePfizer Inc., Worldwide Research & Development, Department of Pharmacokinetics, Dynamics & Metabolism, Eastern Point Road, Groton, CT 06340, USA.
William BrianSanofi, Disposition, Safety & Animal Research, 55 Corporate Drive, Bridgewater, NJ 08807, USA.
Terrye DelMonteBristol Myers Squibb, Clinical Sample Strategy & Operations, Exploratory & Clinical Translational Research, 311 Pennington Rocky Hill Rd, Pennington, NJ 08534, USA.
Stephan FranckeJanssen Research & Development, 1400 McKean Rd, PO Box 776, Spring House, PA 19477, USA.
Peter GroenenActelion Pharmaceuticals Ltd, Translational Science, Gewerbestrasse 16, 4102 Allschwil, Switzerland.
Keith JohnsonVeritas Genetics Inc., 99 Conifer Hill Drive, Danvers, MA 01923, USA.
Lei LiVeritas Genetics Inc., 99 Conifer Hill Drive, Danvers, MA 01923, USA.
Kimberly PearsonSanofi, Disposition, Safety & Animal Research, 55 Corporate Drive, Bridgewater, NJ 08807, USA.
Jean-Claude MarshallPfizer Inc., Worldwide Research & Development, Department of Pharmacokinetics, Dynamics & Metabolism, Eastern Point Road, Groton, CT 06340, USA.

Funding

THE ROLE OF ADVANCED CAA IN ALZHEIMER'S DEMENTIAP50AG005134 · NIA · MASSACHUSETTS GENERAL HOSPITAL · PI HYMAN, BRADLEY T. · 1985 to 2018
$42.1M
Intramural NIH HHS Z99 CA999999NIA NIH HHS P50 AG005134
6 · The paper itself

Abstract

Genetic polymorphisms in metabolizing enzymes and drug transporters have been shown to significantly impact the exposure of drugs having a high dependence on a single mechanism for their absorption, distribution or clearance, such that genotyping can lead to actionable steps in disease treatment. Recently, global regulatory agencies have provided guidance for assessment of pharmacogenomics during early stages of drug development, both in the form of formal guidance and perspectives published in scientific journals. The Industry Pharmacogenomics Working Group (I-PWG), conducted a survey among member companies to assess the practices relating to absorption, distribution, metabolism, excretion pharmacogenomics) during early stages of clinical development, to assess the impact of the recent Regulatory Guidance issued by the US FDA and EMA on Industry practices.

Indexed as

AnimalsClinical Trials as TopicDrug IndustryHumansPharmacogeneticsPharmacokineticsPolymorphism, GeneticPractice Guidelines as TopicUnited StatesUnited States Food and Drug Administrationabsorption, distribution, metabolism and excretionADMEdrug metabolismdrug transporterspharmacogenomicspharmacokineticsRegulatory Guidance

Identifiers

PMID26616152
PMCPMC5558530

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.