Ensuring quality pharmacokinetic analyses in antimicrobial drug development programs. (October 2017)

• Record Type: Journal Article
• Authors: Lakota, Elizabeth A; Bader, Justin C; Rubino, Christopher M
• Is Part Of: Current opinion in pharmacology. Volume 36(2017)
• Page Start: 139
• Page End: 145
• Publication Date: 2017-10
• Subjects: Pharmacology -- Periodicals; Pharmaceutical Preparations -- Periodicals; Drug Therapy -- Periodicals; Biopharmaceutics -- Periodicals; Pharmacologie -- Périodiques; Pharmacology; Periodicals; 615.105
• DOI: 10.1016/j.coph.2017.10.014
• Languages: English
• ISSNs: 1471-4892

Abstract

Highlights: Robust pharmacokinetic analyses should be used to optimize all stages of development. Various methodologies are available to analyze pharmacokinetic data. Study design from a pharmacokinetic perspective is critical. Accurately and precisely collected pharmacokinetic data are essential. Abstract : Pharmacokinetic studies and analyses can be expensive, time consuming, and labor intensive. However, it is crucial to understand that much of what happens in antimicrobial drug development, such as dose-selection and clinical study design, can be optimized with a strong understanding of the underlying pharmacokinetics of an agent. In this way, pharmacokinetics forms the bedrock of a pharmacometric approach to antimicrobial development. Thus, pharmacokinetic analyses must be considered an integral part of a drug's development strategy and studies must be planned and designed accordingly. This paper provides a brief overview of pharmacokinetic analysis methods, including best practices and their use in the context of a drug development program. In addition we will conclude with an overview of proper design and conduct of pharmacokinetic studies to optimize their use in evaluating clinical study data.