Further Reading and References

  • EMA/CPMP/ICH/286/1995: ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals (December 2009).
  • EMA/CHMP/ICH/731268/1998: Committee for medicinal products for human use (CHMP) ICH guidelines S6 (R1) – preclinical safety evaluation of biotechnology-derived pharmaceuticals (June 2011).
  • EMEA/CHMP/SWP/28367/07: Guideline on strategies to identify and mitigate risks for first-in human trials with investigational medicinal products (2007).
  • EMEA/CHMP/SWP/28367/2007: European Medicines Agency (EMEA) (2007b) Guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products.
  • ICH: www.ich.org
  • ICH Safety Guidelines: ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years. (https://www.ich.org/page/safety-guidelines)