[1] 国家食品药品监督管理局. 药物研究技术指导原则:2006~ 2007年[S]. 北京:中国医药科技出版社,2007:143-168. [2] ICH Steering Committee. Harmonised Tripartite Guideline S5 (R2). Detection of toxicity to reproduction for medicinal products and toxicity to male fertility [EB/OL].[2013-02-01]. http://www.ich.org/ products/guidelines/safety/article/safety-guidelines.html [3] 胡文娟,周 莉,孙祖越. 致畸实验阳性对照的选择[J]. 毒理学杂志,2010,24 (2):162-165. [4] 孙祖越,周 莉,闫 晗,等. 如何成功地开展药物临床前生殖毒性试验[J]. 中国新药杂志,2011,20 (22):2195-2204. [5] ICH. M3 (R1) maintenance of the ICH guideline on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals[EB/OL]. [2013-02-01]. http://www.ich.org/ products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.html. [6] ICH. M3 (R2) guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. Step 2 versions[EB/OL]. [2013-02-01]. http: //www.ich.org/products/guidelines/multidisciplinary/article/ multidisciplinary-guidelines.html. [7] 孙祖越,周 莉,韩 玲,等. 生育调节药物非临床安全性评价的特殊性[J]. 中国药理学通报,2012,28 (4):445-450. [8] 孙祖越,周 莉,韩 玲,等. 药物非临床生殖发育毒性试验中逐案原则的建议[J]. 中国新药杂志,2012,21 (8):836-843. [9] Barrow PC. Reproductive toxicity testing for pharmaceuticals under ICH[J]. Reprod Toxicol,2009,28 (2):172-179. [10] Greenberg LH,Tanaka KR. Congenital anomalies probably induced by cyclophosphamide[J]. JAMA,1964,188:423-426. [11] Shulman LN. The biology of alkylating-agent cellular injury[J]. Hematol Oncol Clin North Am,1993,7 (2):325-335. [12] Gomez F,Manalo S,Dallman MF. Androgen-sensitive changes in regulation of restrain-induced adrenocorticotropin secretion between early and late puberty in male rats[J]. Endocrinology, 2004,145 (1):59-70. [13] 岳丽琴,李旭良,魏光辉,等. 环磷酰胺对不同发育时期睾丸生精细胞毒性损伤的动物实验研究[J]. 中华小儿外科杂志,2006,27 (1):38-41. [14] Vaisheva F,Delbes G,Hales BF,et al. Effects of the chemotherapeutic agents for non-Hodgkin lymphoma,cyclop-hosphamide,doxorubicin,vincristine,and prednisone (CHOP), on the male rat reproductive system and progeny outcome[J]. J Androl,2007,28 (4):578-587. [15] 高学勇,王 玮,韩咪沙,等. 环磷酰胺对大鼠睾丸和附睾的影响[J]. 解剖学研究,2009,31 (1):25-43. |