PHARMACOKINETICS AND ADME STUDIES

     

     

    ADME: absorption, distribution, metabolism and excretion

    Pharmacokinetic studies are conducted in order to acquire information on the absorption, distribution in tissues, metabolism and routes of excretion of the test substance and its possible metabolites, and to investigate the mechanism of toxicity and target organs.

    These studies provide very useful information in assessing the safety of the substance, highlighting possible mechanisms of toxicity in relation to the dose level or route of administration used, through the use of the most current techniques of liquid chromatography and mass spectrometry (LC-MS / MS). Studies are also performed on medical devices to check for degradation products and leachable substances.

    OECD Guideline 417: Toxicokinetics

    ICH Guideline S3A: Note for Guidance on Toxicokinetics: a Guidance for Assessing Systemic Exposure in Toxicology Studies

    ISO Standard 10993-16: Toxicokinetic studies for degradation products and leachable substances

    ISO Standard 10993-17: Establishment of allowable limits for leachable substances

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