Your browser doesn't support javascript.
loading
FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective.
Bai, Jane P F; Schmidt, Brian J; Gadkar, Kapil G; Damian, Valeriu; Earp, Justin C; Friedrich, Christina; van der Graaf, Piet H; Madabushi, Rajanikanth; Musante, Cynthia J; Naik, Kunal; Rogge, Mark; Zhu, Hao.
Afiliación
  • Bai JPF; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20903, USA. Jane.Bai@fda.hhs.gov.
  • Schmidt BJ; Quantitative Clinical Pharmacology, Bristol Myers Squibb, Princeton, New Jersey, USA. brian.schmidt@bms.com.
  • Gadkar KG; Development Sciences, Genentech Inc., South San Francisco, California, 94080, USA. gadkar@dnli.com.
  • Damian V; Denali Therapeutics, San Francisco, California, USA. gadkar@dnli.com.
  • Earp JC; GSK R&D - Upper Providence, 1250 S Collegeville Rd, Collegeville, Pennsylvania, 19426, USA.
  • Friedrich C; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
  • van der Graaf PH; Rosa & Co LLC, 751 Laurel St., Ste. 127, San Carlos, California, 94070, USA.
  • Madabushi R; Certara, Canterbury, CT2 7FG, UK.
  • Musante CJ; Leiden Academic Centre for Drug Research, Leiden, 2333, CC, the Netherlands.
  • Naik K; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
  • Rogge M; Early Clinical Development, Pfizer Worldwide Research, Development, & Medical, 1 Portland Street, Cambridge, Massachusetts, 02139, USA.
  • Zhu H; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
AAPS J ; 23(3): 60, 2021 04 30.
Article en En | MEDLINE | ID: mdl-33931790
Asunto(s)
Palabras clave
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Colaboración Intersectorial / Biología de Sistemas / Desarrollo de Medicamentos / Modelos Biológicos Tipo de estudio: Prognostic_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Colaboración Intersectorial / Biología de Sistemas / Desarrollo de Medicamentos / Modelos Biológicos Tipo de estudio: Prognostic_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos