Development of novel contraceptive methods for men and women

开发针对男性和女性的新型避孕方法

• 批准号: 10008861
• 负责人: Diana Blithe
• 金额: $ 54.89万
• 依托单位: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10008861
• 关键词: Address; Biological Testing; Chemistry; Clinical; Clinical Investigator; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive methods; Contracts; Development; Devices; Evaluation; Formulation; Goals; Human; Institution; International; Lead; Methods; Mission; National Institute of Child Health and Human Development; Pharmaceutical Preparations; Phase; Preparation; Program Development; Research; Research Personnel; Safety; Scientist; Site; Technology Transfer; Testing; Toxicology; Training; Translating; Woman; chemical synthesis; clinical research site; drug candidate; first-in-human; good laboratory practice; innovation; meetings; men; method development; next generation; novel; novel therapeutics; preclinical evaluation; preclinical study; programs; research and development; research clinical testing

CDP uses R&D contracts to achieve the goal of new method development. The Program evaluates new drugs that are not commercially available and must be synthesized under current Good Manufacturing Practice (cGMP) that comply with all regulatory standards of Chemistry, Manufacturing and Controls. CDP maintains a contracted Chemical Synthesis Facility to produce novel drugs required for the program. Potential new drugs and devices require toxicology testing to demonstrate safety. IND-enabling preclinical studies must be performed under Good Laboratory Practice (GLP) meeting regulatory standards. Human trials require formulation and release of agents under cGMP, and stability studies covering the duration of the trial. CDP maintains a Biological Testing Facility to perform preclinical evaluation and batch preparation required for first-in-human studies and longer toxicology studies for later Phase clinical trials. Clinical evaluation of the novel products occurs in the Contraceptive Clinical Trials Network (CCTN) under the Program Management of the CDP. The CCTN evaluates safety and efficacy of new contraceptive drugs and devices for women and for men. Results from clinical trials on new entities form the basis for advancing candidate drugs and devices through development with the goal of FDA regulatory approval. The CCTN comprises top clinical investigators at qualified institutions, including both domestic and international sites, with expertise to conduct all phases of contraceptive evaluation, from first-in-human through Phase III. The clinical sites serve as the training ground for the next generation of investigators in the field.

CDP使用研发合同来实现新方法开发的目标。该计划评估尚未上市且必须在符合所有化学、制造和控制法规标准的当前良好制造规范(CGMP)下合成的新药。CDP拥有一个签约的化学合成设施，以生产该计划所需的新药。潜在的新药和设备需要进行毒理学测试以证明其安全性。支持IND的临床前研究必须在符合法规标准的良好实验室操作规范(GLP)下进行。人体试验需要cGMP下的制剂和释放剂，以及涵盖试验持续时间的稳定性研究。CDP拥有一个生物测试设施，以执行临床前评估和批量准备，以进行首次人体研究和后期临床试验的更长时间的毒理学研究。新产品的临床评估在CDP项目管理下的避孕临床试验网络(CCTN)进行。CCTN评估女性和男性使用的新型避孕药和避孕器的安全性和有效性。对新实体的临床试验结果构成了通过开发推进候选药物和设备的基础，目标是获得FDA监管部门的批准。CCTN由合格机构的顶级临床研究人员组成，包括国内和国际站点，他们拥有从首例人类避孕评估到第三阶段避孕评估的所有阶段的专业知识。这些临床站点是该领域下一代研究人员的培训基地。