Further Reading & References
Requisitos de conclusão
- EMA: Available at: Scientific advice and protocol assistance | European Medicines Agency (europa.eu)
- 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): Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m3r2-non-clinical-safety-studies-conduct-human-clinical-trials-marketing-authorisation_en.pdf
- 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): Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical-trials-investigational_en.pdf
- Calculation of the Minimum Anticipated Biological Effect Level (MABEL) and 1st dose in human: Available at: https://www.ema.europa.eu/en/documents/presentation/calculation-minimum-anticipated-biological-effect-level-mabel-1st-dose-human-jennifer-sims_en.pdf
- ICH S5 (R3) guideline on reproductive toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals (2020): Available at: ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - Scientific guideline | European Medicines Agency (europa.eu)