Senior Director Certara London, England, United Kingdom
Clinical pharmacology spans all phases of drug development, and accounts for a substantial proportion of a drug product label. An important goal of drug development programs is to ensure sufficient characterization of the clinical pharmacology of the drug. The clinical pharmacology development strategy therefore needs to take into account both the intrinsic and extrinsic factors that alter drug exposure. Furthermore, the clinical pharmacology development strategy must meet the regulatory requirements of multiple health authorities in order to secure a global product registration. The presentation will highlight the challenges in developing an appropriate clinical pharmacology development strategy in order to establish the right dose for the right patient. An overview of the clinical pharmacology studies required to meet regulatory requirements will be presented including the timing of studies and how the incorporation of quantitative methodologies can help to facilitate dose selection. Examples of how the information generated in a clinical pharmacology program could impact global product labeling will be presented in the context of global regulatory requirements.
Upon completion, participants will understand the key challenges to developing a global clinical pharmacology program
Upon completion, particpants will be able to describe the key clinical pharmacology studies that constiutute a global clinical pharmacology program
Upon completion, participants will be able to discuss the timing of clinical pharmacology studies that are included in global clinical pharmacology program
Upon completion, participants will be able to discuss the benefits of incorporating quantitative methods into a clinical pharmacology program to faciltate dose selection