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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).
Baran, Szczepan W; Brown, Paul C; Baudy, Andreas R; Fitzpatrick, Suzanne C; Frantz, Christopher; Fullerton, Aaron; Gan, Jinping; Hardwick, Rhiannon N; Hillgren, Kathleen M; Kopec, Anna K; Liras, Jennifer L; Mendrick, Donna L; Nagao, Ryan; Proctor, William R; Ramsden, Diane; Ribeiro, Alexandre J S; Stresser, David; Sung, Kyung E; Sura, Radhakrishna; Tetsuka, Kazuhiro; Tomlinson, Lindsay; Van Vleet, Terry; Wagoner, Matthew P; Wang, Qin; Arslan, Sevim Yildiz; Yoder, Gorm; Ekert, Jason E.
Afiliação
  • 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.
ALTEX ; 39(2): 297­314, 2022.
Article em En | MEDLINE | ID: mdl-35064273
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Dispositivos Lab-On-A-Chip / Alternativas aos Testes com Animais Tipo de estudo: Prognostic_studies Limite: Animals País/Região como assunto: America do norte Idioma: En Revista: ALTEX Assunto da revista: MEDICINA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Dispositivos Lab-On-A-Chip / Alternativas aos Testes com Animais Tipo de estudo: Prognostic_studies Limite: Animals País/Região como assunto: America do norte Idioma: En Revista: ALTEX Assunto da revista: MEDICINA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos