The FDA issued the “Guidance for Industry – Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients” which is also accepted for EU authorization. In there, you find a pretty good list of the necessary in-vito strategies and the test principles can be found in the OECD guidelines for health effects.

I hope that helps

Best Regards

Geertje

Regarding in vitro toxicity , it very much depends on the regulatory issues you are thinking. If your thougths are related to immune toxicity, skin irritation, inflammatory assays you should search for the proper guidelines available in the international regulatory agencies such as FDA , EMA, AIFA, TGA, ANVISA, amongst others for investigation of its safety and efficacy . The Orange Book would be a good starting point . Orange Book USA: FDA. Available from: http://www.accessdata.fda.gov/scripts/ cder/ob/docs/queryai.cfm