• Regulatory NewsRegulatory News

    EMA, Drugmakers Weigh FDA Draft Guidance on Physiologically Based PK Analyses

    With an eye toward more harmonization, the European Medicines Agency (EMA) earlier this month weighed in on the US Food and Drug Administration’s (FDA) draft guidance on physiologically based pharmacokinetic (PK) analyses, alongside pharmaceutical companies including Novartis, Merck and Bayer. EMA EMA’s Pharmacokinetic Working Party (PKWP) and the Modelling and Simulation Working Group (MSWG) are developing a “ Guideline on the Qualification and Reporting of Physiologi...
  • Regulatory NewsRegulatory News

    FDA Issues Draft Guidance on Physiologically Based Pharmacokinetic Analyses

    • 01 December 2016
    The US Food and Drug Administration (FDA) on Thursday released a new draft guidance intended to help sponsors report physiologically based pharmacokinetic (PBPK) analyses to the agency in a standardized format. PBPK Analyses According to FDA, "PBPK analysis uses models and simulations that combine physiology, population, and drug characteristics to mechanistically describe the [pharmacokinetic] PK and/or pharmacodynamic (PD) behaviors of a drug." These analyses, FDA sa...