The New First-in-Human EMA Guideline: Disruptive or Constructive? Outcomes From the First EUFEMED Discussion Forum.

Breithaupt-Grögler, Kerstin; Hardman, Tim; de Hoon, Jan; Donazzolo, Yves; Rottey, Sylvie; Sourgens, Hildegard; Stringer, Steffan

Breithaupt-Grögler, Kerstin; Hardman, Tim; de Hoon, Jan; Donazzolo, Yves; Rottey, Sylvie; Sourgens, Hildegard; Stringer, Steffan.

Afiliação

Breithaupt-Grögler K; Association for Applied Human Pharmacology, Hamburg, Germany.
Hardman T; Association for Human Pharmacology in the Pharmaceutical Industry, London, United Kingdom.
de Hoon J; Niche Science & Technology Ltd., Richmond, United Kingdom.
Donazzolo Y; Belgian Association of Phase-1 Units, Brussels, Belgium.
Rottey S; Association Francaise de Pharmacologie Translationnelle (Formally Le Club Phase 1), Lyon, France.
Sourgens H; Belgian Association of Phase-1 Units, Brussels, Belgium.
Stringer S; Association for Applied Human Pharmacology, Hamburg, Germany.

Front Pharmacol ; 10: 398, 2019.

Article em En | MEDLINE | ID: mdl-31068811

Palavras-chave

EMA (European Medicines Agency); EUFEMED; conference report; discussion; early phase clinical drug development; guidelines; revised first-in-human guideline

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Guideline / Qualitative_research Idioma: En Revista: Front Pharmacol Ano de publicação: 2019 Tipo de documento: Article

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google