1. Complicated intra-abdominal infections: developing drugs for treatment Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018 Subject(s): Anti-Bacterial Agents -- therapeutic useClinical Trials as TopicDrug Evaluation -- standardsDrugs, Investigational -- pharmacokineticsIntraabdominal Infections -- drug therapyMicrobiological Techniques -- standardsDrug Labeling -- standardsEndpoint Determination -- standardsResearch Design -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Physiologically based pharmacokinetic analyses--format and content Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018 Subject(s): Drug Evaluation, PreclinicalDrugs, Investigational -- pharmacokineticsInvestigational New Drug ApplicationResearch DesignSoftwareHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.