Further Reading & References
- EMA: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000049.jsp&mid=WC0b01ac05800229b9
- ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals (December 2009, EMA/CPMP/ICH/286/1995): access here.
- Guideline on strategies to identify and mitigate risks for first-in -human and early clinical trials with investigational medicinal products. (20 July 2017 EMEA/CHMP/SWP/28367/07 Rev. 1, Committee for Medicinal Products for Human Use (CHMP):
- Calculation of the Minimum Anticipated Biological Effect Level (MABEL) and 1st dose in human: access here.
- ICH S5 (R3) guideline on reproductive toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals (2020): access here.