Accuracy – Typically expressed as % Relative Error (RE); %RE = 100 x (Determined – Nominal)/Nominal
AUC – Area under the plasma concentration curve
Blank – A sample of biological matrix without analyte or internal standard.
Calibration standard – Used to construct the calibration curve
Cmax – Maximum plasma concentration
Control article - Any food additive, color additive, drug, biological product, electronic product, medical device for human use or any article other than a test article, feed or water that is administered to the test system in the course of a nonclinical laboratory study for the purpose of establishing a basis of comparison with the test article.
Internal standard (IS) – A test compound added to the calibration standards, QCs and study samples at a constant concentration to facilitate quantitation of the analyte.
LLOQ – The lowest nominal concentration of the calibration curve.
Matrix – The biological material in which the analyte is to be determined.
Multiple Reaction Monitoring (MRM) – Scanning in this mode (mass spectrometry) allows multiple transitions in a single time segment.
Nominal - The calculated concentration of analyte in any prepared solution and matrix including concentration of the stock solution, secondary solutions, calibration standards and QCs.
Precision – Degree of agreement among replicate measurements reflected in the standard deviation (SD) of the mean and reported as %CV (coefficient of variation).
Processed sample – The sample that will be used for chromatographic analysis.
Quality control (QC) – A biological matrix that has been spiked at a known concentration with analyte ; used to mimic the storage and handling of study samples.
Raw data – Any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation for the report of that study.
Study director – The individual responsible for the overall conduct of a nonclinical laboratory study.
Sponsor – A person who initiates and supports a nonclinical laboratory study by provision of financial or other resources; a person who submits said study to the FDA in support of an application for a research or marketing permit; or, a testing facility if it both initiates and conducts the study.
Standard curve (Calibration curve) – The relationship between the nominal concentration of the calibration standards and their experimental response values established by regression analysis.
Test article – Any food additive, color additive, drug, biological product, medical device for human use or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act.
Testing facility – A person who conducts a nonclinical laboratory study (uses the test article in a test system).
Test sample – Neat solution or a matrix sample, spiked with analyte (and IS where appropriate) that is used to warm up the instrument and assess system performance.
Test system – Any animal, plant, microorganism, or subparts thereof to which the test or control article is administered or added for study.
Tmax – Time of maximum plasma concentration
ULOQ – Upper level of quantitation. Highest nominal concentration of the calibration curve.
Warning Letter – An informal advisory to a firm communicating the agency’s position on a matter but does not commit FDA to taking enforcement action. The agency’s policy is that Warning Letters should be issued for violations which are of regulatory significance in that failure to adequately and promptly ta Zero – Prepared from either pooled or individual matrices fortified with IS.ke corrective action may be expected to result in enforcement action should the violation(s) continue.