Algorithms to generate designs of potency experiments that use far fewer animals
生成使用更少动物的效力实验设计的算法
基本信息
- 批准号:8810865
- 负责人:
- 金额:$ 16.2万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2015
- 资助国家:美国
- 起止时间:2015-09-01 至 2017-08-31
- 项目状态:已结题
- 来源:
- 关键词:AlgorithmsAnimal Care and Use CommitteesAnimalsAnthrax diseaseArchivesAreaBiological AssayCanis familiarisCessation of lifeDiseaseDistressDoseDrug DesignEffectivenessEnsureEthicsExperimental DesignsGraphHumanHuman ResourcesInteragency Coordinating Committee on the Validation of Alternative MethodsLeadMedical ResearchMonkeysNuclear AccidentsPainPharmaceutical PreparationsPublic HealthRadiationRelative (related person)ResearchResearch DesignResearch PersonnelSample SizeSavingsSpecific qualifier valueTestingVaccinesWorkanimal rulebasecomparativecostdesigndrug efficacyexperienceinterestmeetingsnonhuman primatenovelpotency testingprogramspublic health relevanceradiation effectresearch studyresponsetoolweb site
项目摘要
DESCRIPTION (provided by applicant): Relative potency studies conducted in animals to establish the efficacy of drugs to counter radiation-induced lethality and of vaccines to protect against deadly diseases like anthrax often use more animals than necessary. This appears to be due to the absence of appropriate tools and guidance for the efficient design of such studies, even though there is broad interest in reducing the use of animals, primarily to limit the pain and
suffering the animals may experience (de Moura et al., 2009; McFarland et al., 2011). Given that human studies of agents to protect against lethality and deadly diseases are unethical and infeasible, such studies must be conducted in animals, often in large animals like dogs and nonhuman primates, in accordance with the FDA Animal Rule (FDA 2002, 2009). In this project we will develop easy-to-use design tools to enable researchers to reduce substantially the number of animals they use in potency studies, without sacrificing statistical power. The project will build on our previous work on sample-size determination for radiation lethality studies (Kodell et al., 2010; Landes et al., 2013), in which we discovered that experimental designs with staggered doses of reference and test treatments are far more efficient than traditional, same-dose designs. In this project we will develop novel algorithms that researchers can use to design powerful, staggered-dose experiments that keep animal numbers to a minimum, and to evaluate trade-offs in terms of numbers and placement of doses. Graphical features will allow users to evaluate visually the savings in animal numbers that can be achieved using staggered-dose designs compared to same-dose designs, and to evaluate the effect on power of misspecified input parameters. We will provide the algorithms at no cost in an Excel spreadsheet, SAS/IML macro, and R package (CRAN), along with guidance, to enhance the likelihood that researchers conducting relative potency studies will employ these efficient designs to use the fewest animals possible to meet their objectives.
项目成果
期刊论文数量(0)
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Reid D. Landes其他文献
Evaluation of HPRT-dup-GFP mice for in vivo and in situ somatic mutation analyses
HPRT-dup-GFP 小鼠体内和原位体细胞突变分析的评估
- DOI:
- 发表时间:
2014 - 期刊:
- 影响因子:0
- 作者:
Asao Noda;Hirofumi Suemori;Yuko Hirai;kanya Hamasaki;Yoshiaki Kodama;Hiroshi Mitani;Reid D. Landes;and Nori Nakamura - 通讯作者:
and Nori Nakamura
マウス個体レベルでのin vivo, in situ 体細胞突然変異検出系の開発
小鼠个体水平体内和原位体细胞突变检测系统的开发
- DOI:
- 发表时间:
2014 - 期刊:
- 影响因子:0
- 作者:
Asao Noda;Hirofumi Suemori;Yuko Hirai;kanya Hamasaki;Yoshiaki Kodama;Hiroshi Mitani;Reid D. Landes;and Nori Nakamura;野田朝男 - 通讯作者:
野田朝男
Parameters Influencing Count Recovery Post Autologous Stem Cell Transplantation in Patients with Multiple Myeloma
- DOI:
10.1182/blood-2022-167624 - 发表时间:
2022-11-15 - 期刊:
- 影响因子:
- 作者:
Yetunde Ogunsesan;Reid D. Landes;Jaskirat Sethi;Munawwar Hussain;Nishanth Thalambedu;Lakshmi Yarlagadda;Sravani Gundarlapalli;Clyde Bailey;Samer Al Hadidi;Sharmilan Thanendrarajan;Maurizio Zangari;John D. Shaughnessy;Fenghuang Zhan;Frits van Rhee;Carolina Schinke - 通讯作者:
Carolina Schinke
Levodopa influence on turning dynamics in people with Parkinson’s disease
- DOI:
10.1038/s41598-025-97511-4 - 发表时间:
2025-04-23 - 期刊:
- 影响因子:3.900
- 作者:
Lakshmi Pillai;Reid D. Landes;Tuhin Virmani - 通讯作者:
Tuhin Virmani
Reid D. Landes的其他文献
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相似海外基金
The Use of Animals in Psychological Research: A National Study of Institutional Animal Care and Use Committees
心理学研究中动物的使用:机构动物护理和使用委员会的全国研究
- 批准号:
9616801 - 财政年份:1997
- 资助金额:
$ 16.2万 - 项目类别:
Continuing grant