Доклиника

ICH M3(R2): Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals, 2009

ICH S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies, 1994

ICH S3B: Guidance for repeated dose tissue distribution studies, 1994

ICH S1A: Guideline on the need for carcinogenicity studies of pharmaceuticals, 1995

ICH S1B: Testing for carcinogenicity of pharmaceuticals, 1997

ICH S1C (R2): Dose selection for carcinogenicity studies of pharmaceuticals, 2008

ICH S2 (R1): Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use, 2011

ICH S4: Duration of chronic toxicity testing in animals (rodent and non rodent toxicity testing), 1998

ICH S5 (R2): Detection of toxicity to reproduction for medicinal products & toxicity to male fertility, 2000

ICH S5 (R3): Detection of toxicity to reproduction for human pharmaceuticals, 2017

ICH S6 (R1): Preclinical safety evaluation of biotechnology-derived pharmaceuticals, 2011

ICH S7A: Safety pharmacology studies for human pharmaceuticals, 2000

ICH S7B: The non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals, 2005

ICH S8: Immunotoxicity studies for human pharmaceuticals, 2005

ICH S9: Nonclinical evaluation for anticancer pharmaceuticals, 2009

ICH S10: Photosafety evaluation of pharmaceuticals, 2013

ICH S11: Nonclinical safety testing in support of development of paediatric medicines, 2018

Национальный стандарт РФ ГОСТ Р 56701-2015 «Руководство по планированию доклинических исследований безопасности с целью последующего проведения клинических исследований и регистрации лекарственных средств» (ICH M3(R2)), 2016

Национальный стандарт РФ ГОСТ Р 56702-2015 «Доклинические токсикологические и фармакокинетические исследования безопасности» (ICH S3A, S3B), 2016

Правила надлежащей лабораторной практики Евразийского экономического союза в сфере обращения лекарственных средств (решение комиссии №81 от 06.05.2017 г.)