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A calibration curve plot showing limit of detection (LOD), limit of quantification (LOQ), dynamic range, and limit of linearity (LOL).. In analytical chemistry, a calibration curve, also known as a standard curve, is a general method for determining the concentration of a substance in an unknown sample by comparing the unknown to a set of standard samples of known concentration. [1]
These include the instrument detection limit (IDL), the method detection limit (MDL), the practical quantitation limit (PQL), and the limit of quantitation (LOQ). Even when the same terminology is used, there can be differences in the LOD according to nuances of what definition is used and what type of noise contributes to the measurement and ...
All analytical procedures should be validated. Identification tests are conducted to ensure the identity of an analyte in a sample through comparison of the sample to a reference standard through methods such as spectrum, chromatographic behavior, and chemical reactivity. [5] Impurity testing can either be a quantitative test or a limit test.
Three key points are taken into consideration regarding MRL values in the EU regulation: [4] 1) the amounts of residues found in food must be safe for consumers and must be as low as possible, 2) the European Commission fixes MRLs for all food and animal feed, and 3) the MRLs for all crops and all pesticides can be found in the MRL database on ...
The Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)
The following outline is provided as an overview of and topical guide to clinical research: Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans.
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In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial.