Developmental and reproductive toxicology studies in nonhuman primates.
Developmental and reproductive toxicology testing in nonhuman primates (NHPs) has become more common due to the increasing number of biopharmaceuticals in drug development, since NHPs are frequently the only species to express pharmacologic responses similar to humans. NHPs may also be used to help resolve issues associated with small-molecule reproductive toxicology in traditional species (rodents and rabbits). Adequate designs in NHP are presented for developmental toxicity (embryo-fetal development, pre-postnatal development, enhanced pre-postnatal development), reproductive toxicity (male and female), and juvenile toxicity studies. Optional parameters that may be included in these studies are discussed, as are new study designs that consolidate multiple aspects of the reproductive assessment and thereby conserve the limited supply of sexually mature NHPs available for testing. The details described will assist scientists in pharmaceutical, regulatory, and contract research organizations who are involved in conducting these unique studies to optimize their design based on case-by-case considerations.
Chellman
Gary J
GJ
Charles River Preclinical Services, Reno, Nevada 89511, USA. gary.chellman@crl.com
Bussiere
Jeanine L
JL
Makori
Norbert
N
Martin
Pauline L
PL
Ooshima
Yojiro
Y
Weinbauer
Gerhard F
GF
D000818:Animals; D000830:Animals, Laboratory; D002144:Callithrix / Q000502:physiology; D064420:Drug-Related Side Effects and Adverse Reactions; D047108:Embryonic Development / Q000187:drug effects*; D005260:Female; D047109:Fetal Development / Q000187:drug effects*; D000882:Haplorhini / Q000502:physiology*; D008252:Macaca fascicularis / Q000502:physiology; D008253:Macaca mulatta / Q000502:physiology; D008297:Male; D004364:Pharmaceutical Preparations / Q000145:classification; D011817:Rabbits; D051381:Rats; D012098:Reproduction / Q000187:drug effects* / Q000502:physiology; D013045:Species Specificity; D018675:Toxicity Tests / Q000379:methods*
D004364:Pharmaceutical Preparations