1. Electronic code of federal regulations (e-CFR) title 21. Food and drugs; chapter I. FOOD and drug administration, department of health and human SERVICES; subchapter A. GENERAL; Part 58. Good laboratory practice for nonclinical laboratory studies.
2. (communication from the commission to the European parliament, 2020) SWD(2020) 286 final Communication from the commission to the European parliament, T.C. (2020),2020
3. ICH M3(R2). Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals M3(R2) Current Step 5 version dated December 2009 EMA/CPMP/ICH/286/1995 M3(R2) nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. International Conference on Harmonization (ICH).
4. Committee for Medicinal Products for Human Use (CHMP) Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products Guideline on repeated dose toxicity, Committee for Human Medicinal. CPMP/SWP/1042/99 Rev 1 Core products (CHMP) 20 July 2017 EMEA/CHMP/SWP/28367/07 Rev. 1.
5. Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers;Fed Regist January,2003