Clinical pharmacology considerations in development of gastrohepatology products.
Clinical pharmacology has a key role in advancing candidate drugs from bench to bedside. A thorough understanding of underlying pharmacokinetic (PK) and pharmacodynamic (PD) processes is essential to inform the next steps in any drug development program with the goal of personalized medicine. Development of gastrohepatology drug products faces unique clinical pharmacology challenges that require collaborative efforts from academia, the pharmaceutical industry, and regulatory agencies.
Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. suechih.lee@fda.hhs.gov
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D015415:Biomarkers; D015195:Drug Design; D005765:Gastrointestinal Agents / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use; D005767:Gastrointestinal Diseases / Q000188:drug therapy*; D005769:Gastrointestinal Motility / Q000187:drug effects; D041981:Gastrointestinal Tract / Q000187:drug effects; D006801:Humans; D008099:Liver / Q000187:drug effects; D008107:Liver Diseases / Q000188:drug therapy*; D010601:Pharmacology, Clinical / Q000379:methods*; D013270:Stomach / Q000187:drug effects
D015415:Biomarkers; D005765:Gastrointestinal Agents