Search results
Results From The WOW.Com Content Network
Because of the complex inter-relationship between analytical method, sample concentration, limits of detection and method precision, the management of Analytical Quality Control is undertaken using a statistical approach to determine whether the results obtained lie within an acceptable statistical envelope.
In statistics, intra-rater reliability is the degree of agreement among repeated administrations of a diagnostic test performed by a single rater. [ 1 ] [ 2 ] Intra-rater reliability and inter-rater reliability are aspects of test validity .
Quality control (QC) is a measure of precision, or how well the measurement system reproduces the same result over time and under varying operating conditions. Laboratory quality control material is usually run at the beginning of each shift, after an instrument is serviced, when reagent lots are changed, after equipment calibration, and ...
The repeatability coefficient is a precision measure which represents the value below which the absolute difference between two repeated test results may be expected to lie with a probability of 95%. [citation needed] The standard deviation under repeatability conditions is part of precision and accuracy. [citation needed]
The US Food and Drug Administration issued a Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests. Its availability was announced in the Federal Register, Vol. 68, No. 231 on December 2, 2003 and is listed under "Notices." Presumptive testing has found widespread use by employers and public entities.
TDM interpretation: an anticancer drug is given to a patient at a dosage of 400 mg every day at 8:00 am. A TDM sample is obtained at 6:00 am, showing a drug concentration of 0.46 mg/L. 1) Regarding “normality”, the result is around the 25th percentile, suggesting a rather high drug clearance in this patient.
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
A laboratory specimen is sometimes a biological specimen of a medical patient's tissue, fluids, or other samples used for laboratory analysis to assist in differential diagnosis or staging of a disease process. These specimens are often the most reliable method of diagnosis, depending on the ailment.