Immunological assays ria, elisa,bioluminescence assays

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This is the note on topic Immunological assays ria, elisa,bioluminescence assays for the 1st semester of mpharm of pharmaceutical analysis.

Health & Medicine

Validation: Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results. Calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (for example, weight, temperature and pH), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard.

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The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy. Bioavailability studies are drug product performance studies used to define the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.

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