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  • Regulatory NewsRegulatory News

    FDA Unveils New Tables for Submitting Bioanalytical Methods

    The US Food and Drug Administration (FDA) recently released tables that can be included in submissions for new drug and biologic applications to provide information regarding the bioanalytical methods for pharmacokinetic assessments. “The templates in this guidance are applicable to bioanalytical procedures such as chromatographic assays (CCs) and ligand-binding assays (LBAs) that quantitatively determine the levels of drugs and their metabolites and therapeutic protein...
  • Regulatory NewsRegulatory News

    ICH Proposes Two New Guidelines

    The International Council for Harmonisation (ICH) has announced two new guidelines, with one (M9) providing recommendations to support the biopharmaceutics classification of medicinal products, while the other (M10) applies to the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies. Both of the new plans for the guidelines are part of efforts to harmonize regional differences in guidance documents and were finalized by ICH ...