M10 guidelines describe the bioanalytical method validation expected to support regulatory decisions, specifically for nonclinical toxicokinetic (TK) and pharmacokinetic (PK) studies conducted as surrogates for clinical studies.
In essence, the ICH M10 guideline provides a framework for ensuring the reliability and accuracy of bioanalytical data used in drug development. This is achieved through a structured approach to validating the methods used to quantify drugs and their metabolites in biological samples.
Here's a breakdown:
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Bioanalytical Method Validation: This process ensures that the methods used to measure drug concentrations in biological samples (like blood or plasma) are accurate, reliable, and reproducible.
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Regulatory Decisions: The data generated from these validated methods are crucial for making informed decisions about a drug's safety and efficacy during its development.
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Scope: The M10 guidelines apply primarily to:
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Nonclinical Toxicokinetic (TK) studies: These studies examine how a drug is absorbed, distributed, metabolized, and excreted (ADME) in animals to assess potential toxicity.
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Pharmacokinetic (PK) studies conducted as surrogates for clinical studies: These studies investigate the ADME properties of a drug in humans, with the goal to be able to replace parts of clinical studies with non-clinical studies.
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