PHARMACOKINETICS AND PHARMACODYNAMICS OF SELECTED ANTIBIOTICS DURING PREGNANCY

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。本提案是为了响应FDA的“提案请求”而制定的，旨在评估用于治疗妊娠期和哺乳期女性生物恐怖袭击所致疾病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几个脆弱的亚群，包括孕妇和哺乳期妇女。因此，无法评价给药方案的优化。为患者合理开药必须确保最大可能的临床获益，同时将风险降至最低。只有在适当患者人群中获得足够的药代动力学-药效学和安全性信息时，才能实现这一目标。

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.