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EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals.
van der Laan, Jan Willem; Andersson, Mikael; Beken, Sonja; Bonelli, Milton; Brendler-Schwaab, Susanne; Kane, Rosemary; Pasanen, Markku; Ponzano, Stefano; Paur, Jakob; Siezen, Christine; Soleng, Anne; Whomsley, Rhys.
Afiliação
  • van der Laan JW; Medicines Evaluation Board, Utrecht, The Netherlands.
  • Andersson M; ICH S1 Expert Working Group, European Medicines Agency, Amsterdam, The Netherlands.
  • Beken S; Division of Drug Discovery and Safety, Leiden Academic Centre for Drug Research, University of Leiden, Leiden, Netherlands.
  • Bonelli M; Medical Products Agency, Uppsala, Sweden.
  • Brendler-Schwaab S; Federal Agency for Medicines and Health Products, Brussels, Belgium.
  • Kane R; European Medicines Agency, Amsterdam, The Netherlands.
  • Pasanen M; Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.
  • Ponzano S; Health Products Regulatory Authority, Dublin, Ireland.
  • Paur J; ICH S1 Expert Working Group, European Medicines Agency, Amsterdam, The Netherlands.
  • Siezen C; School of Pharmacy, University of Eastern Finland, Kuopio, Finland.
  • Soleng A; European Medicines Agency, Amsterdam, The Netherlands.
  • Whomsley R; Austrian Medicines and Medical Devices Agency (AGES), Vienna, Austria.
Br J Clin Pharmacol ; 89(8): 2341-2348, 2023 08.
Article em En | MEDLINE | ID: mdl-37265032
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medição de Risco Tipo de estudo: Etiology_studies / Guideline / Risk_factors_studies Limite: Humans Idioma: En Revista: Br J Clin Pharmacol Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Holanda
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medição de Risco Tipo de estudo: Etiology_studies / Guideline / Risk_factors_studies Limite: Humans Idioma: En Revista: Br J Clin Pharmacol Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Holanda