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Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate).

Autor: Baran SW; Emerging Technologies, Novartis Institutes for BioMedical Research, Cambridge, MA, USA., Brown PC; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, USA., Baudy AR; ADME & Discovery Toxicology, Merck & Co., Inc., Kenilworth, NJ, USA., Fitzpatrick SC; U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of the Center Director, College Park, MD, USA., Frantz C; Translational Sciences, Seagen, Seattle, WA, USA., Fullerton A; Safety Assessment, Genentech, South San Francisco, CA, USA., Gan J; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb Research and Development, Princeton, NJ, USA., Hardwick RN; Translational Safety Sciences, Theravance Biopharma US, Inc., South San Francisco, CA, USA., Hillgren KM; Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA., Kopec AK; Drug Safety Research & Development, Pfizer, Inc., Groton, CT, USA., Liras JL; Pharmacokinetics, Dynamics and Metabolism, Pfizer Inc., Cambridge, MA, USA., Mendrick DL; U.S. Food and Drug Administration, National Center for Toxicological Research, Office of the Center Director, Silver Spring, MD, USA., Nagao R; Translational Sciences, Seagen, Seattle, WA, USA., Proctor WR; Safety Assessment, Genentech, South San Francisco, CA, USA., Ramsden D; Global Drug Metabolism and Pharmacokinetics, Takeda Pharmaceuticals International Co., Cambridge, MA, USA., Ribeiro AJS; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology, Division of Applied Regulatory Science, Silver Spring, MD, USA., Stresser D; Drug Metabolism, Pharmacokinetics and Bioanalysis, AbbVie, Inc., North Chicago, IL, USA., Sung KE; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Tissues and Advanced Therapies, Division of Cellular and Gene Therapies, Silver Spring, MD, USA., Sura R; Global Preclinical Safety, AbbVie Inc., North Chicago, IL, USA., Tetsuka K; Analysis & Pharmacokinetics Research Labs., Astellas Pharma Inc., Tsukuba-shi, Ibaraki, Japan., Tomlinson L; Global Pathology, DSRD, Pfizer WRD, Cambridge, MA, USA., Van Vleet T; AbbVie, Inc., Chicago, IL, USA., Wagoner MP; Drug Safety Research & Evaluation, Takeda Pharmaceuticals International Co., Cambridge, MA, USA., Wang Q; Drug Safety Research & Evaluation, Takeda Pharmaceuticals International Co., Cambridge, MA, USA., Arslan SY; BioAnalysis, Applied Research Management & Biomedical Science (AMS), Astellas Pharma Inc., Northbrook, IL, USA., Yoder G; Aimmune (Nestlé Health Sciences), Brisbane, CA, USA., Ekert JE; In Vitro In Vivo Translation, Research, Pharmaceutical R&D, GlaxoSmithKline, Collegeville, PA, USA.

Publikováno v: ALTEX [ALTEX] 2022; Vol. 39 (2), pp. 297–314. Date of Electronic Publication: 2022 Jan 21.