ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals: A Perspective from Regulators on the Development of the Guideline

Author:

Leighton John K.,Olejniczak Klaus,Onodera Hiroshi

Publisher

Springer New York

Reference11 articles.

1. DeGeorge JJ, Ahn CH, Andrews PA, Brower ME, Giorgio DW, Goheer MA, Lee-Ham DY, McGuinn WD, Schmidt W, Sun CJ, Tripathi SC (1998) Regulatory considerations for preclinical development of anticancer drugs. Cancer Chemother Pharmacol 41(3):173–185

2. EMA (1998) Committee for Proprietary Medicinal Products: Note for guideline on the pre-clinical evaluation of anticancer medicinal products; CPMP/SWP/997/96. EMA, London

3. EORTC New Drug Development Committee (1985) EORTC guidelines for Phase I trials with single agents in adults. Eur J Cancer Clin Oncol 21:1005–1007

4. Final Concept Paper (2007) S9: Preclinical guideline on oncology therapeutic development. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S9/Concept_papers/S9_Concept_Paper.pdf . Accessed 21 Mar 2012

5. ICH S5 (R2) (2000) Detection of toxicity to reproduction for medicinal products & toxicity to male fertility. http://www.ich.org/products/guidelines/safety/article/safety-guidelines.html .

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