PHARMACOKINETICS AND PHARMACODYNAMICS OF SELECTED ANTIBIOTICS DURING PREGNANCY

妊娠期间选定抗生素的药代动力学和药效学

• 批准号: 7379507
• 负责人: Linda Jean Heffner
• 金额: $ 0.08万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379507
• 关键词: PHARMACOKINETICS; PHARMACODYNAMICS; SELECTED; ANTIBIOTICS; DURING

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This proposal was developed in response to the FDA "Request for Proposals" to assess changes in pharmacokinetics and pharmacodynamics of selected anti-infective agents to treat medical conditions resulting from a bioterrorist attack in prgnant and lactating women. The FDA has identified that dosing and safety data of many anti-infective agents were not available for several vulnerable subpopulations including pregnant and lactating women. As a result, the optimization of dosage regimens cannot be evaluated. Rational prescribing for the patient must attempt to ensure the greatest likelihood of clinical benefit while minimizing risk. This can only be achieved when adequate pharmacokinetic-pharmacodynamic and safety information is available in the appropriate patient population.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本提案是为响应FDA“提案请求”而制定的，旨在评估用于治疗孕妇和哺乳期妇女生物恐怖袭击导致的医疗状况的选定抗感染药物的药代动力学和药效学变化。FDA已经确定，许多抗感染药物的剂量和安全性数据无法用于包括孕妇和哺乳期妇女在内的几个易感亚人群。因此，不能评价最佳的给药方案。合理的处方必须尽量确保最大可能的临床获益，同时将风险降到最低。只有在适当的患者群体中有足够的药代动力学-药效学和安全性信息时，才能实现这一目标。