Guidance Helps Sponsors Evaluate Drug Effects Due to Genetic Differences

A final FDA guidance offers tips on study designs, along with data collection and analysis techniques that can be used in early-phase trials to help evaluate how genetic variations could affect a drug’s pharmacokinetics, pharmacodynamics, efficacy or safety. The pharmacogenomics guidance is relevant for exploratory Phase I and II trials and observational studies intended to generate genomic hypotheses that may then be tested in prospectively designed Phase III trials.
Washington Drug Letter