PHARMACOKINETICS AND PHARMACODYNAMICS OF SELECTED ANTIBIOTICS DURING PREGNANCY

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项建议是为了响应FDA评估选定抗感染药物在药代动力学和药效学方面的变化而制定的，这些药物用于治疗因孕妇和哺乳期妇女遭受生物恐怖袭击而导致的医疗状况。FDA已经确定，许多抗感染药物的剂量和安全性数据对于包括孕妇和哺乳期妇女在内的几个易受感染的亚群来说是不可用的。因此，无法对给药方案的优化进行评估。合理给病人开药必须尽量确保临床获益的可能性最大，同时将风险降至最低。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，才能实现这一点。

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.