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How to Interpret an Investigator's Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum.
Rengelshausen, Jens; Breithaupt-Groegler, Kerstin; Donath, Frank; Erb-Zohar, Katharina; Hardman, Tim; Mikus, Gerd; Plassmann, Stephanie; Wensing, Georg; Sourgens, Hildegard.
Afiliación
  • Rengelshausen J; Association for Applied Human Pharmacology (AGAH e.V.), Goernestrasse 30, 20249, Hamburg, Germany. jens.rengelshausen@grunenthal.com.
  • Breithaupt-Groegler K; Grünenthal GmbH, Clinical Science, Zieglerstr. 6, 52078, Aachen, Germany. jens.rengelshausen@grunenthal.com.
  • Donath F; Association for Applied Human Pharmacology (AGAH e.V.), Goernestrasse 30, 20249, Hamburg, Germany.
  • Erb-Zohar K; -kbr- Clinical Pharmacology Services, 60431, Frankfurt am Main, Germany.
  • Hardman T; Association for Applied Human Pharmacology (AGAH e.V.), Goernestrasse 30, 20249, Hamburg, Germany.
  • Mikus G; SocraTec Research and Development GmbH, 99084, Erfurt, Germany.
  • Plassmann S; Association for Applied Human Pharmacology (AGAH e.V.), Goernestrasse 30, 20249, Hamburg, Germany.
  • Wensing G; clinphase®, 63679, Schotten, Germany.
  • Sourgens H; Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI), London, UK.
Ther Innov Regul Sci ; 55(3): 612-618, 2021 05.
Article en En | MEDLINE | ID: mdl-33537954
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Folletos / Sujetos de Investigación Tipo de estudio: Etiology_studies / Guideline / Risk_factors_studies Límite: Humans Idioma: En Revista: Ther Innov Regul Sci Año: 2021 Tipo del documento: Article País de afiliación: Alemania
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Folletos / Sujetos de Investigación Tipo de estudio: Etiology_studies / Guideline / Risk_factors_studies Límite: Humans Idioma: En Revista: Ther Innov Regul Sci Año: 2021 Tipo del documento: Article País de afiliación: Alemania