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Page 1
The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.
Prior H, Andrews L, Cauvin A, Chien H, Clarke DO, Datta K, Dempster M, Dybdal N, Freebern W, de Haan L, Herzyk D, Hey A, Kissner T, Kronenberg S, Leach MW, Lee D, Reid K, Schutte K, Sewell F, Trouba K, Ulrich P, van Aerts L, van Meer P, Weir L. Prior H, et al. Among authors: weir l. Regul Toxicol Pharmacol. 2023 Feb;138:105339. doi: 10.1016/j.yrtph.2023.105339. Epub 2023 Jan 14. Regul Toxicol Pharmacol. 2023. PMID: 36649820 Free article. Review.
Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation.
Prior H, Baldrick P, Beken S, Booler H, Bower N, Brooker P, Brown P, Burlinson B, Burns-Naas LA, Casey W, Chapman M, Clarke D, de Haan L, Doehr O, Downes N, Flaherty M, Gellatly N, Moesgaard SG, Harris J, Holbrook M, Hui J, Jones D, Jones K, Kedar H, Mahl A, Manninen A, McGuire A, Mortimer-Cassen E, Peraza M, Pugsley MK, Richard J, Roberts R, Roosen W, Rothfuss A, Schoenmakers A, Sewell F, Weaver R, Weir L, Wolfreys A, Kimber I. Prior H, et al. Among authors: weir l. Regul Toxicol Pharmacol. 2020 Jun;113:104624. doi: 10.1016/j.yrtph.2020.104624. Epub 2020 Feb 29. Regul Toxicol Pharmacol. 2020. PMID: 32126256 Free article.
Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.
Chien HT, Prior H, Andrews L, van Aerts L, Cauvin A, Clarke DO, Datta K, Dempster M, Dybdal N, Freebern W, de Haan L, Herzyk D, Hey A, Kissner T, Kronenberg S, Leach MW, Lee D, Schutte K, Sewell F, Trouba K, Ulrich P, Weir L, van Meer P. Chien HT, et al. Among authors: weir l. Regul Toxicol Pharmacol. 2023 Feb;138:105329. doi: 10.1016/j.yrtph.2022.105329. Epub 2022 Dec 30. Regul Toxicol Pharmacol. 2023. PMID: 36592682 Free article.
Biotherapeutics in non-clinical development: Strengthening the interface between safety, pharmacokinetics-pharmacodynamics and manufacturing.
Ulrich P, Blaich G, Baumann A, Fagg R, Hey A, Kiessling A, Kronenberg S, Lindecrona RH, Mohl S, Richter WF, Tibbitts J, Crameri F, Weir L. Ulrich P, et al. Among authors: weir l. Regul Toxicol Pharmacol. 2018 Apr;94:91-100. doi: 10.1016/j.yrtph.2018.01.013. Epub 2018 Jan 28. Regul Toxicol Pharmacol. 2018. PMID: 29355662
Nonclinical Development of Biologics: Integrating Safety, Pharmacokinetics, and Pharmacodynamics to Create Smarter and More Flexible Nonclinical Safety Programs Optimizing Animal Use.
Hey A, Baumann A, Kronenberg S, Blaich G, Mohl S, Fagg R, Ulrich P, Rattel B, Richter WF, Kiessling A, Weir L. Hey A, et al. Among authors: weir l. Int J Toxicol. 2021 May-Jun;40(3):270-284. doi: 10.1177/1091581821994288. Epub 2021 Feb 25. Int J Toxicol. 2021. PMID: 33631988
Validating and updating the OHTS-EGPS model predicting 5-year glaucoma risk among ocular hypertension patients using electronic records.
Wright DM, Azuara-Blanco A, Cardwell C, Montesano G, Crabb DP, Gazzard G, King AJ, Hernández R, Morgan JE, Higgins B, Takwoingi Y; GRIP study group. Wright DM, et al. Ophthalmol Glaucoma. 2024 Nov 4:S2589-4196(24)00187-X. doi: 10.1016/j.ogla.2024.10.009. Online ahead of print. Ophthalmol Glaucoma. 2024. PMID: 39505150 Free article.
Evaluating the Safety and Efficacy of Telemedicine Physician Assessments on a Mobile Stroke Unit: Protocol for a Prospective Open-Label Blinded End-Point Randomized Controlled Trial.
Yogendrakumar V, Balabanski AH, Johns H, Churilov L, Parsons NK, Beharry J, Weir L, Yassi N, Zhao H, Warwick A, Coote S, Langenberg F, Branagan L, Siddiqi W, Bivard A, Campbell BCV, Donnan GA, Davis SM; MSU‐TELEMED Investigators †. Yogendrakumar V, et al. Among authors: weir l. J Am Heart Assoc. 2024 Nov 5;13(21):e036856. doi: 10.1161/JAHA.124.036856. Epub 2024 Oct 18. J Am Heart Assoc. 2024. PMID: 39424402 Free article.
209 results