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.