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Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part I. Biotherapeutics.
Frazier KS, Engelhardt JA, Fant P, Guionaud S, Henry SP, Leach MW, Louden C, Scicchitano MS, Weaver JL, Zabka TS; Society of Toxicologic Pathology Vascular Injury Working Group. Frazier KS, et al. Among authors: engelhardt ja. Toxicol Pathol. 2015 Oct;43(7):915-34. doi: 10.1177/0192623315570340. Epub 2015 Feb 26. Toxicol Pathol. 2015. PMID: 25722122 Review.
Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part 2. Antisense Oligonucleotides.
Engelhardt JA, Fant P, Guionaud S, Henry SP, Leach MW, Louden C, Scicchitano MS, Weaver JL, Zabka TS, Frazier KS; Society of Toxicologic Pathology Vascular Injury Working Group. Engelhardt JA, et al. Toxicol Pathol. 2015 Oct;43(7):935-44. doi: 10.1177/0192623315570341. Epub 2015 Feb 24. Toxicol Pathol. 2015. PMID: 25717082 Review.
Characterizing Adversity of Lysosomal Accumulation in Nonclinical Toxicity Studies: Results from the 5th ESTP International Expert Workshop.
Lenz B, Braendli-Baiocco A, Engelhardt J, Fant P, Fischer H, Francke S, Fukuda R, Gröters S, Harada T, Harleman H, Kaufmann W, Kustermann S, Nolte T, Palazzi X, Pohlmeyer-Esch G, Popp A, Romeike A, Schulte A, Lima BS, Tomlinson L, Willard J, Wood CE, Yoshida M. Lenz B, et al. Toxicol Pathol. 2018 Feb;46(2):224-246. doi: 10.1177/0192623317749452. Toxicol Pathol. 2018. PMID: 29471779
The Application, Challenges, and Advancement Toward Regulatory Acceptance of Digital Toxicologic Pathology: Results of the 7th ESTP International Expert Workshop (September 20-21, 2019).
Schumacher VL, Aeffner F, Barale-Thomas E, Botteron C, Carter J, Elies L, Engelhardt JA, Fant P, Forest T, Hall P, Hildebrand D, Klopfleisch R, Lucotte T, Marxfeld H, Mckinney L, Moulin P, Neyens E, Palazzi X, Piton A, Riccardi E, Roth DR, Rousselle S, Vidal JD, Williams B. Schumacher VL, et al. Among authors: engelhardt ja. Toxicol Pathol. 2021 Jun;49(4):720-737. doi: 10.1177/0192623320975841. Epub 2020 Dec 10. Toxicol Pathol. 2021. PMID: 33297858
Underlying Immune Disorder May Predispose Some Transthyretin Amyloidosis Subjects to Inotersen-Mediated Thrombocytopenia.
Narayanan P, Curtis BR, Shen L, Schneider E, Tami JA, Paz S, Burel SA, Tai LJ, Machemer T, Kwoh TJ, Xia S, Shattil SJ, Witztum JL, Engelhardt JA, Henry SP, Monia BP, Hughes SG. Narayanan P, et al. Among authors: engelhardt ja. Nucleic Acid Ther. 2020 Apr;30(2):94-103. doi: 10.1089/nat.2019.0829. Epub 2020 Feb 11. Nucleic Acid Ther. 2020. PMID: 32043907 Clinical Trial.
Perspective on Adversity in Toxicology Evaluations.
Engelhardt JA, Dorato MA. Engelhardt JA, et al. Toxicol Pathol. 2021 Feb;49(2):408-410. doi: 10.1177/0192623320941791. Epub 2020 Aug 18. Toxicol Pathol. 2021. PMID: 32807041
60 results