ГОСТ Р 56699-2015 Лекарственные средства для медицинского применения. Доклинические исследования безопасности биотехнологических лекарственных препаратов. Общие рекомендации (Переиздание)

[1]

ICH S5(R2) Guideline

Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility; June 1993

[2]

ICH S1A Guideline

Guideline on the Need for Carcinogenicity Studies for Pharmaceuticals; November 1995

[3]

ICH M3(R2) Guideline

Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals; June 2009

[4]

ICH S9 Guideline

Nonclinical Evaluation for Anticancer Pharmaceuticals; November 2008

[5]

Pentsuk N., Van der Laan J.W. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth defects research (Part B) 2009; 86: 328-344

[6]

Jarvis P., Srivastav S., Vogelwedde E., Stewart J., Mitchard T., Weinbauer G. The Cynomolgous Monkey as a model for Developmental Toxicity Studies: Variability of Pregnancy losses, Statistical power estimates, and Group Size considerations. Birth Defects Research (Part B) 2010, 89: 175-187

УДК 615.038:615.012/.014:615.2:006.354

ОКС 11.020

11.120.01

19.020

Ключевые слова: лекарственные средства, доклинические исследования, исследования безопасности, биотехнологические лекарственные препараты, государственная регистрация