The nonclinical fertility study design for pharmaceuticals

Birth Defects Research Part B - Developmental and Reproductive Toxicology

Volumn 86, Issue 6, 2009, Pages 429-436

  Lerman, Steven A ^a   Hew, Kok Wah ^b   Stewart, Jane ^c   Stump, Donald G ^d   Wise, L David ^e  

^a GLAXOSMITHKLINE   (United States)

^b TAKEDA PHARMACEUTICALS   (United States)

^c ASTRAZENECA   (United Kingdom)

^d WIL RESEARCH LABORATORIES   (United States)

^e MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Early embryonic development; Hazard identification; Mating fertility; Pharmaceuticals; Reproductive toxicity; Safety assessment

Indexed keywords

THALIDOMIDE;

BODY WEIGHT; DRUG INDUSTRY; EMBRYO DEVELOPMENT; EMBRYOTOXICITY; ESTRUS CYCLE; FEMALE FERTILITY; FETUS DEVELOPMENT; FOOD INTAKE; GENITAL SYSTEM; HAZARD ASSESSMENT; HUMAN; MALE FERTILITY; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; TERATOGENICITY;

ANIMALS; EMBRYONIC DEVELOPMENT; FEMALE; FERTILITY; INTERNATIONAL AGENCIES; INTERNATIONAL COOPERATION; MALE; MODELS, ANIMAL; PHARMACEUTICAL PREPARATIONS; RATS; RESEARCH DESIGN; RISK ASSESSMENT; TIME FACTORS; TOXICITY TESTS;

RATTUS;

EID: 73649136088     PISSN: 15429733     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdrb.20221     Document Type: Review

References (19)

1. Barrow PC. 2009. Reproductive toxicity testing for pharmaceuticals under ICH. Reprod Toxicol 28:172-179.
2. Blazak WF. 1989. Significance of cellular end points in assessment of male reproductive toxicity. In: Working PW, editor. Toxicology of the male and female reproductive systems. New York: Hemisphere Publishing Corp, p 158.
3. Cavagnaro JA. 2002. Preclinical safety evaluation of biotechnology- derived pharmaceuticals. Nature Rev Drug Discov 1:469-475.
4. Chapin RE, Gulati DK, Barnes LH, Teague JL. 1993. The effects of feed restriction on reproductive function in Sprague-Dawley rats. Fundam Appl Toxicol 20:23-29.
5. Christian MS, Hoberman AM. 1983. Current in vivo reproductive toxicity and teratology methods. In: Homberger, editor. Safety evaluation and regulation of chemicals 2. 2nd Int. Conf., Cambridge, Mass. p 78-88.
6. Christian MS, Hoberman AM. 1997. Perspectives on the U.S., EEC, and Japanese developmental toxicity guidelines. In: Hood RD, editor. Handbook of developmental toxicology. New York: CRL Press, Inc., p 551-595.
7. Christian MS, Hoberman AM, Lewis EM. 2006. Perspectives on the developmental and reproductive toxicity guidelines. In: Hood RD, editor. Handbook of developmental toxicology. New York: CRL Press, Inc., p 733-798.
8. Collins TFX. 1978. Reproduction and teratology guidelines: review of deliberation by the National Toxicology Advisory Committee's Reproduction Panel. J Environ Pathol Toxicol 2:141-147.
9. Goldman JM, Murr AS, Cooper RL. 2007. The rodent estrous cycle: characterization of vaginal cytology and its utility in toxicological studies. Birth Defects Res B 80:84-97.
10. Lanning LL, Creasy DM, Chapin RE, Mann PC, Barlow NJ, Regan KS, Goodman DG. 2002. Recommended approaches for the evaluation of testicular and epididymal toxicity. Toxicol Pathol 30:507-520.
11. Martin PL, Breslin W, Rocca M, Wright D, Cavagnaro J. 2009. Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals. Birth Defects Res B 86:176-203.
12. Rocca MS, Wehner NG. 2009. The guinea pig as an animal model for developmental and reproductive toxicology studies. Birth Defects Res B 86:92-97.
13. Sakai T, Takahashi M, Mitsumori K, Yasuhara K, Kawashima K, Mayahara H, Ohno Y. 2000. Collaborative work to evaluate toxicity on male reproductive organs by repeated dose studies in rats. J Toxicol Sci 25(Special Issue):1-21.
14. Sanbuissho A, Yoshida M, Hisada S, Sagami F, Kudo S, Kumazawa T, Ube M, Komatsu S, Ohno Y. 2009. Collaborative work on evaluation of ovarian toxicity by repeated-dose and fertility studies in female rats. J Toxicol Scs 34(Special Issue I):SP1-SP22.
15. Takayama S, Akaike M, Kawashima K, Takahashi M, Kurokawa Y. 1995. A collaborative study in Japan on optimal treatment period and parameters for detection of male fertility disorders in rats induced by medical drugs. J Am Coll Toxicol 14:266-292.
16. Teo SK, Denny KH, Stirling DI, Thomas SD, Morseth SL, Hoberman AM. 2004. Effects of thalidomide on reproductive function and early embryonic development in male and female New Zealand White rabbits. Birth Defects Res B 71:1-16.
17. Terry KK, Chatman LA, Foley GL, Kadyszewski E, Fleeman TL, Hurtt ME, Chapin RE. 2005. Effects of feed restriction on fertility in female rats. Birth Defects Res B 75:431-441.
18. Ulbrich B, Palmer AK. 1995. Detection of ef fects on male reproduction. A literature survey. J Am Coll Toxicol 14:293-327.
19. Wise LD, Spence S, Saldutti LP, Kerr JS. 2007. Assessment of female and male fertility in Sprague-Dawley rats administered vorinostat, a histone deacetylase inhibitor. Birth Defects Res (Part B) 83:19-26.