| Developmental and reproductive toxicology studies in nonhuman primates. | |
| | |
MedLine Citation:
|
PMID: 20025046 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
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. |
| | |
Authors:
|
Gary J Chellman; Jeanine L Bussiere; Norbert Makori; Pauline L Martin; Yojiro Ooshima; Gerhard F Weinbauer |
Related Documents
:
|
11228706 - Comparability of thermodynamic data--a metrological point of view. 14550656 - Developing environmental quality standards for various pesticides and priority pollutan... 19501126 - Evaluation for skin sensitization based on published literatures (existing information)... 15518966 - Chemical reactivity assessments in r&d. 18095086 - Application of an individual-based model with real data for transportation mode and loc... 21047376 - Classification of genomic islands using decision trees and their ensemble algorithms. |
Publication Detail:
|
Type: Comparative Study; Journal Article; Review |
Journal Detail:
|
Title: Birth defects research. Part B, Developmental and reproductive toxicology Volume: 86 ISSN: 1542-9741 ISO Abbreviation: Birth Defects Res. B Dev. Reprod. Toxicol. Publication Date: 2009 Dec |
Date Detail:
|
Created Date: 2009-12-24 Completed Date: 2010-02-23 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 101155115 Medline TA: Birth Defects Res B Dev Reprod Toxicol Country: United States |
Other Details:
|
Languages: eng Pagination: 446-62 Citation Subset: IM |
Copyright Information:
|
2009 Wiley-Liss, Inc. |
Affiliation:
|
Charles River Preclinical Services, Reno, Nevada 89511, USA. gary.chellman@crl.com |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Animals Animals, Laboratory Callithrix / physiology Embryonic Development / drug effects* Female Fetal Development / drug effects* Haplorhini / physiology* Macaca fascicularis / physiology Macaca mulatta / physiology Male Pharmaceutical Preparations / adverse effects*, classification Rabbits Rats Reproduction / drug effects*, physiology Species Specificity Toxicity Tests / methods* |
| Chemical | |
Reg. No./Substance:
|
0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Drug-eluting stent fracture: Incidence, contributing factors, and clinical implications.
Next Document: Juvenile animal toxicity study designs to support pediatric drug development.