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Scientific and Regulatory Policy Committee Points to Consider: Sampling, Processing, Evaluation, Interpretation, and Reporting of Test Article-Related Ganglion Pathology for Nonclinical Toxicity Studies.
Bennet BM, Pardo ID, Assaf BT, Buza E, Cramer S, Crawford LK, Engelhardt JA, Grubor B, Morrison JP, Osborne TS, Sharma AK, Bolon B. Bennet BM, et al. Among authors: engelhardt ja. Toxicol Pathol. 2023 Jun;51(4):176-204. doi: 10.1177/01926233231179707. Epub 2023 Jul 25. Toxicol Pathol. 2023. PMID: 37489508
Scientific and Regulatory Policy Committee Technical Review: Biology and Pathology of Ganglia in Animal Species Used for Nonclinical Safety Testing.
Bennet BM, Pardo ID, Assaf BT, Buza E, Cramer SD, Crawford LK, Engelhardt JA, Galbreath EJ, Grubor B, Morrison JP, Osborne TS, Sharma AK, Bolon B. Bennet BM, et al. Among authors: engelhardt ja. Toxicol Pathol. 2023 Jul;51(5):278-305. doi: 10.1177/01926233231213851. Toxicol Pathol. 2023. PMID: 38047294 Review.
Safety and Tolerability of GalNAc3-Conjugated Antisense Drugs Compared to the Same-Sequence 2'-O-Methoxyethyl-Modified Antisense Drugs: Results from an Integrated Assessment of Phase 1 Clinical Trial Data.
Baker BF, Xia S, Partridge W, Engelhardt JA, Tsimikas S, Crooke ST, Bhanot S, Geary RS. Baker BF, et al. Among authors: engelhardt ja. Nucleic Acid Ther. 2024 Feb;34(1):18-25. doi: 10.1089/nat.2023.0026. Epub 2024 Jan 16. Nucleic Acid Ther. 2024. PMID: 38227794 Clinical Trial.
Safety, Pharmacokinetic, and Pharmacodynamic Evaluation of a 2'-(2-Methoxyethyl)-D-ribose Antisense Oligonucleotide-Triantenarry N-Acetyl-galactosamine Conjugate that Targets the Human Transmembrane Protease Serine 6.
Zanardi TA, Korbmacher B, Boone L, Engelhardt JA, Wang Y, Burel S, Prill B, Aghajan M, Guo S, Henry SP. Zanardi TA, et al. Among authors: engelhardt ja. J Pharmacol Exp Ther. 2021 Apr;377(1):51-63. doi: 10.1124/jpet.120.000222. Epub 2021 Jan 11. J Pharmacol Exp Ther. 2021. PMID: 33431610
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
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
56 results