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Considerations from an International Regulatory and Pharmaceutical Industry (IQ MPS Affiliate) Workshop on the Standardization of Complex In Vitro Models in Drug Development.
Tomlinson, Lindsay; Ramsden, Diane; Leite, Sofia Batista; Beken, Sonja; Bonzo, Jessica A; Brown, Paul; Candarlioglu, Pelin L; Chan, Tom S; Chen, Eugene; Choi, Colin K; David, Rhiannon; Delrue, Nathalie; Devine, Patrick J; Ford, Kevin; Garcia, Martha Iveth; Gosset, James R; Hewitt, Philip; Homan, Kimberly; Irrechukwu, Onyi; Kopec, Anna K; Liras, Jennifer L; Mandlekar, Sandhya; Raczynski, Arek; Sadrieh, Nakissa; Sakatis, Melanie Z; Siegel, Jeffrey; Sung, Kyung; Sunyovszki, Ilona; Van Vleet, Terry R; Ekert, Jason E; Hardwick, Rhiannon N.
Afiliación
  • Tomlinson L; Global Pathology, Pfizer Inc., Cambridge, MA, 02140, USA.
  • Ramsden D; DMPK Oncology, AstraZeneca, Boston, MA, 02451, USA.
  • Leite SB; European Commission Joint Research Centre, Ispra, 21027, Italy.
  • Beken S; Federal Agency for Medicines and Health Products, Brussels, 1210, Belgium.
  • Bonzo JA; Center for Drug Evaluation and Research, Office of New Drugs, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Brown P; Center for Drug Evaluation and Research, Office of New Drugs, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Candarlioglu PL; Complex In Vitro Models, GSK, Stevenage, SG1 2NY, UK.
  • Chan TS; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, 06877, USA.
  • Chen E; DMPK, Genentech, South San Francisco, CA, 94080, USA.
  • Choi CK; Preclinical Safety, Biogen, Cambridge, MA, 02142, USA.
  • David R; Clinical Pharmacology & Safety Sciences, AstraZeneca, Cambridge, CB2 0AA, UK.
  • Delrue N; Organisation for Economic Co-operation and Development, Paris, 75016, France.
  • Devine PJ; Discovery Toxicology, Bristol Myers Squibb, San Diego, CA, 09130, USA.
  • Ford K; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Garcia MI; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Gosset JR; DMPK, Pfizer Inc., Cambridge, MA, 02139, USA.
  • Hewitt P; Chemical and Preclinical Safety, Merck Healthcare KGaA, 64293, Darmstadt, Germany.
  • Homan K; Complex in Vitro Systems Group, Genentech, South San Francisco, CA, 94080, USA.
  • Irrechukwu O; Preclinical Sciences and Translational Safety, Johnson and Johnson Innovation Medicine, Spring House, PA, 19002, USA.
  • Kopec AK; Drug Safety Research & Development, Pfizer Inc., Groton, CT, 06340, USA.
  • Liras JL; Pharmacokinetics, Dynamics & Metabolism-Medicine Design, Pfizer, Cambridge, MA, 02139, USA.
  • Mandlekar S; Clinical Pharmacology, Genentech, South San Francisco, CA, 94080, USA.
  • Raczynski A; Preclinical Safety Assessment, Vertex Pharmaceuticals Inc., Boston, MA, 02210, USA.
  • Sadrieh N; Center for Drug Evaluation and Research, Office of New Drugs, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Sakatis MZ; Non-Clinical Safety, In Vitro/In Vivo Translation, GSK R&D, Ware, SG12 9TJ, UK.
  • Siegel J; Center for Drug Evaluation and Research, Office of New Drugs, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Sung K; Center for Biologics Evaluation and Research, Office of Cellular Therapy and Human Tissue, Cellular and Tissue Therapy Branch, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Sunyovszki I; Translational Cellular Sciences, Biogen, Cambridge, MA, 02142, USA.
  • Van Vleet TR; AbbVie, Inc., North Chicago, IL, 60064, USA.
  • Ekert JE; UCB Pharma, Cambridge, MA, 02140, USA.
  • Hardwick RN; Discovery Toxicology, Bristol Myers Squibb, San Diego, CA, 09130, USA.
Adv Biol (Weinh) ; : e2300131, 2023 Oct 09.
Article en En | MEDLINE | ID: mdl-37814378
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Texto completo: 1 Banco de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Año: 2023 Tipo del documento: Article
Texto completo
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XML
PubMed Links
Buscar en Google

Texto completo: 1 Banco de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Año: 2023 Tipo del documento: Article