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Year | Number of Results |
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2019 | 1 |
2022 | 1 |
2023 | 2 |
2024 | 2 |
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Page 1
The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.
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.
A roadmap towards a human-centric safety assessment of advanced therapy medicinal products.
Chien HT, de Leeuw VC, van Esterik JCJ, Russel FGM, Kienhuis AS, Theunissen PT, van Meer P.
Chien HT, et al.
Regul Toxicol Pharmacol. 2024 Jun;150:105631. doi: 10.1016/j.yrtph.2024.105631. Epub 2024 Apr 20.
Regul Toxicol Pharmacol. 2024.
PMID: 38648873
Free article.
Item in Clipboard
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.
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.
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Reduced FXR Target Gene Expression in Copper-Laden Livers of COMMD1-Deficient Dogs.
Wu X, Chien H, van Wolferen ME, Kruitwagen HS, Oosterhoff LA, Penning LC.
Wu X, et al. Among authors: chien h.
Vet Sci. 2019 Sep 30;6(4):78. doi: 10.3390/vetsci6040078.
Vet Sci. 2019.
PMID: 31574998
Free PMC article.
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The use of weight-of-evidence approaches to characterize developmental toxicity risk for therapeutic monoclonal antibodies in humans without in vivo studies.
Chien HT, Roos P, Russel FGM, Theunissen PT, van Meer PJK.
Chien HT, et al.
Regul Toxicol Pharmacol. 2024 Sep;152:105682. doi: 10.1016/j.yrtph.2024.105682. Epub 2024 Jul 31.
Regul Toxicol Pharmacol. 2024.
PMID: 39094967
Free article.
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