Study on a safety of drugs and chemicals

Assessment of toxicity is carried out according to:

  1. Guideline for experimental (preclinical) studying of new pharmacological substances”, M., JSC Meditsina Publishing House, 2005;
  2. Manual for conducting preclinical studies of drugs. Under the editorship of Mironov A.N., Bunatyan N.D. et al., M., publishing house ‘Grif and K’, 2012;
  3. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) – Safety topics – S3A, S3B, S4, S5, S7B, S8;
  4. OECD protocols on testing of drugs in toxicological studies;
  5. ISO 10993 series “Medical Products. Assessment of biological effect of medical products”.