ГОСТ Р 56701—2015
Библиография
[1] ЮН S6 Guideline: Preclmical Safety Evaluation for Biotechnological-Derived Pharmaceuticals; July 1997.
[2] ICH E8 Guideline: General Considerations for Clinical Trials; July 1997.
[3] ICH S5(R2) Guideline: Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male
Fertility; June 1993.
[4] ICH S1C(R2) Guideline: Dose Selection for Carcinogenicity Studies of Pharmaceuticals: March 2008.
[5] ICH S7A Guideline: Safety Pharmacology Studies for Human Pharmaceuticals: November 2000.
[6] ICH S7B Guideline: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT
Interval Prolongation) By Human Pharmaceuticals; May 2005.
[7] ICH S3A Guideline: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity
Studies: October 1994.
[8] National Centre for the Replacement. Refinement and Reduction of Animals in Research. Challenging
Requirements for Acute Toxicity Studies: Workshop Report; May 2007.
[9] Robinson S., Delongeas JL.. Donald E.. Dreher D.. Festag M.. Kervyn S. et al. A European pharmaceutical
company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development.
Regul Toxicol Pharmacol 2008;50:345-352.
[10] ICH S2B Guideline: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals; July 1997.
[11] ICH S1A Guideline: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals: November 1995.
[12] ICH Q3A(R2) Guideline: Impurities in New Drug Substances; October 2006.
[13] ICH Q3B{R2) Guideline: Impurities in New Drug Products: June 2006.
[14] ICH S8 Guideline: Immunotoxicity Studies for Human Pharmaceuticals; September 2005.
[15] Sakai T., Takahashi M., Mitsumori K.. Yasuhara K.. Kawashima K.. Mayahara H. et al. Collaborative work to
evaluate toxicity on male reproductive organs by 2-week repeated-dose toxicity studies in rats. Overview of the studies. J
Toxicol Sci 2000:25:1-21.
[16] Sanbuissho A.. Yoshida M.. Hisada S.. Sagami F.. Kudo S.. Kumazawa T. et al. Collaborative work on
evaluation of ovarian toxicity by repeated-dose and fertility studies in female rats. J Toxicol Sci 2009;34:1-22.
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