Ensuring quality pharmacokinetic analyses in antimicrobial drug development programs

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HIGHLIGHTSRobust 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.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.

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