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Testing the nonclinical Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm with an established anti-seizure medication: Levetiracetam case study.
Delaunois A, Mathy FX, Cornet M, Gryshkova V, Korlowski C, Bonfitto F, Koch J, Schlit AF, Hebeisen S, Passini E, Rodriguez B, Valentin JP. Delaunois A, et al. Among authors: valentin jp. Pharmacol Res Perspect. 2023 Feb;11(1):e01059. doi: 10.1002/prp2.1059. Pharmacol Res Perspect. 2023. PMID: 36748725 Free PMC article.
Improving the in Vivo QTc assay: The value of implementing best practices to support an integrated nonclinical-clinical QTc risk assessment and TQT substitute.
Vargas HM, Rossman EI, Wisialowski TA, Nichols J, Pugsley MK, Roche B, Gintant GA, Greiter-Wilke A, Kleiman RB, Valentin JP, Leishman DJ. Vargas HM, et al. Among authors: valentin jp. J Pharmacol Toxicol Methods. 2023 May-Jun;121:107265. doi: 10.1016/j.vascn.2023.107265. Epub 2023 Mar 28. J Pharmacol Toxicol Methods. 2023. PMID: 36997076 Free article. Review.
Best practice considerations for nonclinical in vivo cardiovascular telemetry studies in non-rodent species: Delivering high quality QTc data to support ICH E14/S7B Q&As.
Rossman EI, Wisialowski TA, Vargas HM, Valentin JP, Rolf MG, Roche BM, Riley S, Pugsley MK, Nichols J, Li D, Leishman DJ, Kleiman RB, Greiter-Wilke A, Gintant GA, Engwall MJ, Delaunois A, Authier S. Rossman EI, et al. Among authors: valentin jp. J Pharmacol Toxicol Methods. 2023 Sep-Oct;123:107270. doi: 10.1016/j.vascn.2023.107270. Epub 2023 May 8. J Pharmacol Toxicol Methods. 2023. PMID: 37164235
The state of the art in secondary pharmacology and its impact on the safety of new medicines.
Brennan RJ, Jenkinson S, Brown A, Delaunois A, Dumotier B, Pannirselvam M, Rao M, Ribeiro LR, Schmidt F, Sibony A, Timsit Y, Sales VT, Armstrong D, Lagrutta A, Mittlestadt SW, Naven R, Peri R, Roberts S, Vergis JM, Valentin JP. Brennan RJ, et al. Among authors: valentin jp. Nat Rev Drug Discov. 2024 May 21. doi: 10.1038/s41573-024-00942-3. Online ahead of print. Nat Rev Drug Discov. 2024. PMID: 38773351 Review.
Collaborative science in action: A 20 year perspective from the Health and Environmental Sciences Institute (HESI) Cardiac Safety Committee.
Pierson JB, Berridge B, Blinova K, Brooks MB, Eldridge S, O'Brien CE, Pugsley MK, Schultze AE, Smith G, Stockbridge N, Valentin JP, Vicente J. Pierson JB, et al. Among authors: valentin jp. J Pharmacol Toxicol Methods. 2024 May 6;127:107511. doi: 10.1016/j.vascn.2024.107511. Online ahead of print. J Pharmacol Toxicol Methods. 2024. PMID: 38710237 Free article.
Developing a pragmatic consensus procedure supporting the ICH S1B(R1) weight of evidence carcinogenicity assessment.
Bassan A, Steigerwalt R, Keller D, Beilke L, Bradley PM, Bringezu F, Brock WJ, Burns-Naas LA, Chambers J, Cross K, Dorato M, Elespuru R, Fuhrer D, Hall F, Hartke J, Jahnke GD, Kluxen FM, McDuffie E, Schmidt F, Valentin JP, Woolley D, Zane D, Myatt GJ. Bassan A, et al. Among authors: valentin jp. Front Toxicol. 2024 Apr 5;6:1370045. doi: 10.3389/ftox.2024.1370045. eCollection 2024. Front Toxicol. 2024. PMID: 38646442 Free PMC article.
193 results