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EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals.
van der Laan JW, Andersson M, Beken S, Bonelli M, Brendler-Schwaab S, Kane R, Pasanen M, Ponzano S, Paur J, Siezen C, Soleng A, Whomsley R. van der Laan JW, et al. Among authors: bonelli m. Br J Clin Pharmacol. 2023 Aug;89(8):2341-2348. doi: 10.1111/bcp.15790. Epub 2023 Jun 2. Br J Clin Pharmacol. 2023. PMID: 37265032 No abstract available.
Nonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditions.
Sheean ME, Stoyanova-Beninska V, Capovilla G, Duarte D, Hofer MP, Hoffmann M, Magrelli A, Mariz S, Tsigkos S, Shaili E, Polsinelli B, Ricciardi M, Bonelli M, Balabanov P, Larsson K, Sepodes B. Sheean ME, et al. Among authors: bonelli m. Drug Discov Today. 2018 Jan;23(1):26-48. doi: 10.1016/j.drudis.2017.09.015. Epub 2017 Oct 4. Drug Discov Today. 2018. PMID: 28987289 Review.
273 results