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An assay is an investigative (analytic) ... Assays have become a routine part of modern medical, environmental, pharmaceutical, and forensic technology.
Direct assay In a direct assay, the stimulus applied to the subject is specific and directly measurable, and the response to that stimulus is recorded. The variable of interest is the specific stimulus required to produce a response of interest (ex. death of the subject). [6] [12] Indirect assay
In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [1]
Many scientific endeavors are dependent upon accurate quantification of drugs and endogenous substances in biological samples; the focus of bioanalysis in the pharmaceutical industry is to provide a quantitative measure of the active drug and/or its metabolite(s) for the purpose of pharmacokinetics, toxicokinetics, bioequivalence and exposure ...
Validation of analytical procedures is imperative in demonstrating that a drug substance is suitable for a particular purpose. [5] Common validation characteristics include: accuracy, precision (repeatability and intermediate precision), specificity, detection limit, quantitation limit, linearity, range, and robustness.
Molecular diagnostics uses in vitro biological assays such as PCR-ELISA or Fluorescence in situ hybridization. [19] [20] The assay detects a molecule, often in low concentrations, that is a marker of disease or risk in a sample taken from a patient. Preservation of the sample before analysis is critical.
A drug reference standard or pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.
The assay is a solid-phase type of enzyme immunoassay (EIA) to detect the presence of a ligand (commonly a protein) in a liquid sample using antibodies directed against the ligand to be measured. ELISA has been used as a diagnostic tool in medicine, plant pathology , and biotechnology , as well as a quality control check in various industries.