• 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    FDA Issues Draft Guidance on Physiologically Based Pharmacokinetic Analyses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    The US Food and Drug Administration (FDA) on Thursday released a new draft guidance intended to help sponsors report physiologically based pharmacokinetic (PBPK) analyses to the agency in a standardized format.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...
  • Regulatory NewsRegulatory News

    ICH Advances Q&A Document on Microsampling

    The International Conference for Harmonization (ICH) on Thursday announced its members had adopted a draft version of a question and answers (Q&A) document intended to provide clarification on the use of microsampling in study animals. Microsampling is the process of using minimal amounts of blood (less than 50 microliters (μl) per ICH guidelines) drawn for testing purposes. Specifically, the Q&A document provides insight on the types of pharmaceuticals microsampl...
  • New Guidance on Studies Involving Geriatric Patients Released by FDA

    The US Food and Drug Administration (FDA) released a final guidance on 21 February that provides insight into how sponsors should conduct clinical trials when their studies are likely to involve elderly patients. FDA's Guidance for Industry - E7 Studies in Support of Special Populations: Geriatrics conforms to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document of the same nam...
  • EMA Publishes Pharmacogenetics Guideline for Evaluation of Medicines

    The European Medicines Agency (EMA) published a new guideline on the use of pharmacogenetics in evaluating pharmacokinetics of medicines on 10 February. The guideline provides specific requirements and recommendations for designing, conducting, dosing, and evaluating clinical studies. The guideline also discusses how to use information obtained in clinical studies for labeling and treatment recommendations. The guideline notes that "genetic variation can affect the ab...