Issues And Safety Challenges In Bio-analysis

The degree of validation is influenced by the purpose of the endogenous analyte data, either assessing exploratory and safety biomarkers or determining pharmacokinetics of an endogenous therapy. The study of biotransformation is an essential part of the drug development process, providing valuable information on drug metabolism enzymatic pathways, the pharmacokinetics of the parent drug and its primary metabolites, the identification of chemically reactive metabolites from which there is potential for drug interactions, genetic polymorphisms and other unwarranted effects such as drug induced toxicity. Before a drug receives regulatory and market approval it has to be studied in non-clinical and clinical studies to demonstrate its safety and efficacy.

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