Evidence map›Paper›PMID 39496990›Full record

ArticlePharmaceutical research2024

The Current State of Biotransformation Science - Industry Survey of In Vitro and In Vivo Practices, Clinical Translation, and Future Trends.

John P Savaryn, Kevin Coe, Matthew A Cerny, Kevin Colizza, Patricia Moliner, Lloyd King, Bin Ma, Jim Atherton, Adam Auclair, Mark T Cancilla and 17 more

Abstract read
In one paragraph

Article in Pharmaceutical research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

27 authors.

John P SavarynAbbVie, Quantitative, Translational & ADME Sciences, North Chicago, IL, USA. john.savaryn@abbvie.com.ORCID http://orcid.org/0000-0002-7997-8444
Kevin CoeJ&J, Translational PKPD & Investigational Toxicology, San Diego, CA, USA.
Matthew A CernyPfizer, Inc, Groton, CT, USA.
Kevin ColizzaGSK, DMPK Disposition and Biotransformation, Collegeville, PA, USA. kevin.x.colizza@gsk.com.
Patricia MolinerSanofi, Montpellier, France.
Lloyd KingUCB Biopharma, Dept. of DMPK, Slough, UK.
Bin MaGenentech, Inc., Department of Drug Metabolism and Pharmacokinetics, South San Francisco, CA, USA.
Jim AthertonIncyte Research Institute, Translational Sciences, Wilmington, DE, USA.
Adam AuclairBoehringer Ingelheim Pharmaceuticals, Inc.,Drug Metabolism and Pharmacokinetics, Ridgefield, CT, USA.
Mark T CancillaMerck & Co., Inc., Pharmacokinetics, Dynamics, Metabolism, and Bioanalysis, Rahway, NJ, USA.
Marsha EnoEisai Inc., Global Drug Metabolism and Pharmacokinetics, Cambridge, MA, USA.
Ulrik JurvaAstraZeneca, Drug Metabolism and Pharmacokinetics (DMPK), Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, Gothenburg, Sweden.
Qin YueGilead Sciences, Inc., Drug Metabolism Dept, Foster City, CA, USA.
Sean Xiaochun ZhuTakeda Development Center Americas, Inc., Drug Metabolism and Pharmacokinetics & Modeling, Cambridge, MA, USA.
Elyse FreibergerAbbVie, Quantitative, Translational & ADME Sciences, North Chicago, IL, USA.
Guo ZhongAmgen, Pharmacokinetics and Drug Metabolism Department, South San Francisco, CA, USA.
Ben BarlockBlueprint Medicines, Cambridge, MA, USA.
Jonny NachtigallMerck Healthcare KGaA, Department NCE DMPK, Darmstadt, Germany.
Laurent LaboureurR&D Paris-Saclay Servier Institute, DMPK, Gif-Sur-Yvette, France.
Sandeepraj PusalkarServier Bioinnovation, LLC, DMPK, Boston, MA, USA.
Runcong GuoBeigene, DMPK, Department of Biology, Shanghai, China.
Michael NiehuesBayer AG, In Vitro ADME & Isotope Chemistry, Berlin, Germany.
Simon HauriRoche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland.
Ester Tor CarrerasNovartis Pharma AG, Novartis Institute for Biomedical Research, Basel, Switzerland.
Christine MaurerMerck Healthcare KGaA, Department NCE DMPK, Darmstadt, Germany.
Chandra PrakashDMPK/Clinical Pharmacology, Agios Pharmaceuticals, Cambridge, MA, USA.
Gary J JenkinsAbbVie, Quantitative, Translational & ADME Sciences, North Chicago, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Embedded within the field of drug metabolism and pharmacokinetics (DMPK), biotransformation is a discipline that studies the origins, disposition, and structural identity of metabolites to provide a comprehensive safety assessment, including the assessment of exposure coverage in toxicological species. Spanning discovery and development, metabolite identification (metID) scientists employ various strategies and tools to address stage-specific questions aimed at guiding the maturation of early chemical matter into drug candidates. During this process, the identity of major (and minor) circulating human metabolites is ascertained to comply with the regulatory requirements such as the Metabolites in Safety Testing (MIST) guidance. Through the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), the "Translatability of MetID In Vitro Systems Working Group" was created within the Translational and ADME Sciences Leadership Group. The remit of this group was to objectively determine how accurate commonly employed in vitro systems have been with respect to prediction of circulating human metabolites, both qualitatively and quantitatively. A survey composed of 34 questions was conducted across 26 pharmaceutical companies to obtain a foundational understanding of current metID practices, preclinically and clinically, as well as to provide perspective on how successful these practices have been at predicting circulating human metabolites. The results of this survey are presented as an initial snapshot of current industry-based metID practices, including our perspective on how a harmonized framework for the conduct of in vitro metID studies could be established. Future perspectives from current practices to emerging advances with greater translational capability are also provided.

Indexed as

BiotransformationDrug IndustryAnimalsDrug DevelopmentDrug DiscoveryDrug Evaluation, PreclinicalHumansPharmaceutical PreparationsSurveys and QuestionnairesTranslational Research, BiomedicalPharmaceutical PreparationsADMEbiotransformationIVIVCMetID

Identifiers

PMID39496990
PMCPMC11599300

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.