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Spontaneous unilateral renal dysplasia in a clinically healthy cynomolgus monkey (Macaca fascicularis)

Autor: Shirai, Norimitsu, Muravnick, Kathleen B., Lettiere, Daniel J., Evans, Mark

Publikováno v: In Experimental and Toxicologic Pathology October 2014 66(8):403-405

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Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls).

Autor: Masuda-Herrera MJ; Nonclinical Safety and Pathobiology (NSP), Gilead Sciences, Inc., Foster City, CA, USA; Melisa.Masuda-Herrera@gilead.com., Bercu JP; Nonclinical Safety and Pathobiology (NSP), Gilead Sciences, Inc., Foster City, CA, USA., Broschard TH; Merck Healthcare KGaA, Frankfurter Str. 250, 64293 Darmstadt, Germany., Burild A; Safety Sciences, Imaging and Data Management, Novo Nordisk A/S, Novo Nordisk Park 2760 Måløv, Denmark., Hasselgren C; Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080., Parris P; Pfizer Worldwide Research and Development, Sandwich, United Kingdom., Ford LC; Department of Veterinary Integrative Biosciences, Interdisciplinary Faculty of Toxicology Program, Texas A&M University, 4466 TAMU, College Station, TX, 77843-4466., Graham J; Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080., Stanard B; Ultragenyx Pharmaceutical Inc., Novato, CA., Comerford M; Pfizer Global Research & Development, Groton, CT, 06340., Lettiere D; Pfizer Global Research & Development, Groton, CT, 06340., Erler S; Wella Company, Berliner Allee 65, 64295 Darmstadt, Germany., Callis CM; Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN., Morinello E; Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080., Muster W; Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland., Martin EA; Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, United Kingdom., Griffin TR; Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, 19380; and., Nagao L; Faegre Drinker Biddle & Reath LLP, Washington, DC., Cruz M; Faegre Drinker Biddle & Reath LLP, Washington, DC.

Publikováno v: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2022 Sep-Oct; Vol. 76 (5), pp. 369-383. Date of Electronic Publication: 2022 Jan 14.