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
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 r...
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| Format: | Article |
| Language: | English |
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Wiley
2025-08-01
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| Series: | Epilepsia Open |
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| Online Access: | https://doi.org/10.1002/epi4.12721 |
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| author | Lisa Coles Patrick A. Forcelli Karine Leclercq Anna‐Maria Katsarou Brian D. Klein Heidrun Potschka Rudiger Koehling Lauren Harte‐Hargrove Aristea S. Galanopoulou Cameron S. Metcalf |
| author_facet | Lisa Coles Patrick A. Forcelli Karine Leclercq Anna‐Maria Katsarou Brian D. Klein Heidrun Potschka Rudiger Koehling Lauren Harte‐Hargrove Aristea S. Galanopoulou Cameron S. Metcalf |
| author_sort | Lisa Coles |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-c012fbfdabad4fa894f47076f4a48484 |
| institution | Kabale University |
| issn | 2470-9239 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Wiley |
| record_format | Article |
| series | Epilepsia Open |
| spelling | doaj-art-c012fbfdabad4fa894f47076f4a484842025-08-25T10:12:58ZengWileyEpilepsia Open2470-92392025-08-0110S1S9S1710.1002/epi4.12721Preclinical 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 ForceLisa Coles0Patrick A. Forcelli1Karine Leclercq2Anna‐Maria Katsarou3Brian D. Klein4Heidrun Potschka5Rudiger Koehling6Lauren Harte‐Hargrove7Aristea S. Galanopoulou8Cameron S. Metcalf9Department of Experimental and Clinical Pharmacology The University of Minnesota, College of Pharmacy Minneapolis Minnesota USADepartment of Pharmacology & Physiology Georgetown University Washington District of Columbia USAEarly Solutions Department UCB Pharma Braine‐l'Alleud BelgiumLaboratory of Developmental Epilepsy, Saul R. Korey Department of Neurology Albert Einstein College of Medicine Bronx New York USANational Institute of Neurological Disorders and Stroke, National Institutes of Health Bethesda Maryland USAInstitute of Pharmacology, Toxicology, and Pharmacy Ludwig‐Maximilians‐University Munich GermanyOscar‐Langendorff‐Institute of Physiology Rostock University Medical Center Rostock GermanyCURE Epilepsy Chicago Illinois USAIsabelle Rapin Division of Child Neurology, Saul R. Korey Department of Neurology Albert Einstein College of Medicine Bronx New York USADepartment of Pharmacology and Toxicology The University of Utah, College of Pharmacy Salt Lake City Utah USAAbstract 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.https://doi.org/10.1002/epi4.12721animal modelcase report formcommon data elementpharmacologypreclinical |
| spellingShingle | Lisa Coles Patrick A. Forcelli Karine Leclercq Anna‐Maria Katsarou Brian D. Klein Heidrun Potschka Rudiger Koehling Lauren Harte‐Hargrove Aristea S. Galanopoulou Cameron S. Metcalf 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 Epilepsia Open animal model case report form common data element pharmacology preclinical |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | animal model case report form common data element pharmacology preclinical |
| url | https://doi.org/10.1002/epi4.12721 |
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