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. 2025 Aug;10 Suppl 1(Suppl 1):S9-S17.
doi: 10.1002/epi4.12721. Epub 2023 Mar 21.

Preclinical common data elements for general pharmacological studies (pharmacokinetic sample collection, tolerability, and drug administration). A report of the TASK3-WG1A General Pharmacology Working Group of the ILAE/AES Joint Translational Task Force

Lisa Coles  1 , Patrick A Forcelli  2   3 , Karine Leclercq  4 , Anna-Maria Katsarou  5 , Brian D Klein  6 , Heidrun Potschka  7 , Rudiger Koehling  8 , Lauren Harte-Hargrove  9 , Aristea S Galanopoulou  10   11 , Cameron S Metcalf  12
Affiliations

Preclinical common data elements for general pharmacological studies (pharmacokinetic sample collection, tolerability, and drug administration). A report of the TASK3-WG1A General Pharmacology Working Group of the ILAE/AES Joint Translational Task Force

Lisa Coles et al. Epilepsia Open. 2025 Aug.

Abstract

Growing concerns over rigor and reproducibility of preclinical studies, including consistency across laboratories and translation to clinical populations, have triggered efforts to harmonize methodologies. This includes the first set of preclinical common data elements (CDEs) for epilepsy research studies, as well as Case Report Forms (CRFs) for widespread use in epilepsy research. The General Pharmacology Working Group of the ILAE/AES Task Force (TASK3-WG1A) has continued in this effort by adapting and refining CDEs/CRFs to address specific study design areas as they relate to preclinical drug screening: general pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), and tolerability. This work has expanded general pharmacology studies to include dose records, PK/PD, tolerability, and elements of rigor and reproducibility. Tolerability testing CRFs included rotarod and Irwin/Functional Observation Battery (FOB) assays. The material provided in the form of CRFs can be delivered for widespread use within the epilepsy research community.

Keywords: animal model; case report form; common data element; pharmacology; preclinical.

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Conflict of interest statement

K Leclercq is full‐time employee of UCB Pharma SA. H Potschka received funding for consulting, talks and research collaborations from Eisai, Zogenix, Elanco, Roche, Lario, Exeed Epidarex, Angelini, MSD, Jazz Pharmaceuticals and Galapagos. AS Galanopoulou is the Editor‐in‐Chief of Epilepsia Open, associate editor of Neurobiology of Disease, and receives royalties from Elsevier, Medlink, and Morgan and Claypool for publications. CS Metcalf is a paid consultant of Sea Pharmaceuticals, LLC. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines. This report was written by experts selected by the ILAE and the AES and was approved for publication by the ILAE and AES. Opinions expressed by the authors, however, do not necessarily represent the policy or position of the ILAE or AES. This report does not represent the official view of the National Institute of Neurological Disorders and Stroke (NINDS), the National Institutes of Health (NIH), or any part of the US Federal Government. No official support or endorsement of this article by the NINDS or NIH is intended or should be inferred.

Figures

FIGURE 1
FIGURE 1
Overview of the general pharmacology working group (TASK3‐WG1A) preclinical case report forms (CRFs).
See this image and copyright information in PMC

References

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