British journal of clinical pharmacology. 2023 Jun 2. doi: 10.1111/bcp.15790
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EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals.
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van der Laan JW1, Andersson M2, Beken S3, Bonelli M4, Brendler-Schwaab S5, Kane R6, Pasanen M7, Ponzano S8, Paur J9, Siezen C10, Soleng A11, Whomsley R12 |
 Author information
1Medicines Evaluation Board, Utrecht, The Netherlands.
2Medical Products Agency, Uppsala, Sweden.
3Federal Agency for Medicines and Health Products, Brussels, Belgium.
4European Medicines Agency, Amsterdam, The Netherlands.
5Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.
6Health Products Regulatory Authority, Dublin, Ireland.
7ICH S1 Expert Working Group, European Medicines Agency, Amsterdam, The Netherlands.
8European Medicines Agency, Amsterdam, The Netherlands.
9Austrian Medicines and Medical Devices Agency (AGES), Vienna, Austria.
10Medicines Evaluation Board, Utrecht, The Netherlands.
11Norwegian Medicines Agency, Oslo, Norway.
12European Medicines Agency, Amsterdam, The Netherlands.
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KEYWORDS: 3Rs, ICHS1, carcinogenicity, human pharmaceuticals, regulatory assessment, weight of evidence
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Publikations ID: 37265032
Quelle: öffnen
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