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Home » Guidance Helps Sponsors Evaluate Drug Affects Due to Genetic Differences
Guidance Helps Sponsors Evaluate Drug Affects Due to Genetic Differences
February 1, 2013
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 (PK), pharmacodynamics (PD), efficacy or safety.