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Immunogenicity/hypersensitivity of biologics.
Leach MW, Rottman JB, Hock MB, Finco D, Rojko JL, Beyer JC. Leach MW, et al. Toxicol Pathol. 2014 Jan;42(1):293-300. doi: 10.1177/0192623313510987. Epub 2013 Nov 14. Toxicol Pathol. 2014. PMID: 24240973
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. Among authors: leach mw. Toxicol Pathol. 2015 Oct;43(7):935-44. doi: 10.1177/0192623315570341. Epub 2015 Feb 24. Toxicol Pathol. 2015. PMID: 25717082 Review.
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: leach mw. Toxicol Pathol. 2015 Oct;43(7):915-34. doi: 10.1177/0192623315570340. Epub 2015 Feb 26. Toxicol Pathol. 2015. PMID: 25722122 Review.
Nonclinical assessments of the potential biosimilar PF-06439535 and bevacizumab.
Peraza MA, Rule KE, Shiue MHI, Finch GL, Thibault S, Brown PR, Clarke DW, Leach MW. Peraza MA, et al. Among authors: leach mw. Regul Toxicol Pharmacol. 2018 Jun;95:236-243. doi: 10.1016/j.yrtph.2018.03.020. Epub 2018 Mar 21. Regul Toxicol Pharmacol. 2018. PMID: 29574193 Free article.
75 results