Preferred Label : Bioanalytical Validation Method;

NCIt related terms : precision testing; quality control testing; Method validation; Bioanalytical Validation Methods; BVM;

NCIt definition : A process that ensures the use of selective, sensitive, and validated analytical methods for the quantitative evaluation of drugs and their metabolites (analytes) and biomarkers, for the successful conduction of nonclinical and/or clinical trials.;

Alternative definition : CareLex: Documentation of the process and use of control data that a laboratory employs to consistently and reproducibly report results that are reliable; may include but is not limited to reporting of calibration and control results for a research test parameter, antibody or pharmacokinetic testing that may be performed by an internal or external laboratory. Bioanalytical Validation Method documentation is required if certification or accreditation is not available for the study test method. [Adapted from TMF-RM];

NCI Metathesaurus CUI : CL473416;

Details


Main resources

You can consult :


https://dumas.ccsd.cnrs.fr/dumas-04412816
2023
France
dissertations, academic
Biomedicine
Delphi Process
Teenager
adolescent medicine
consultants
Family Practice
Clinical Outcome Assessment Content Validation
general practice
Adolescent
Bioanalytical Validation Method
Consulting Physician
Adolescents
delphi technique
consensus
adolescence

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31/10/2024


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