International coordination and validation of analytical methods. 1993

W Horwitz
Food and Drug Administration, Washington, DC 20204.

Most experimentation dealing with analytical methodology in the physical and biological sciences has been conducted within a single laboratory. Method validation by other laboratories was considered not only unnecessary but also detrimental because, in the words of one commentator, 'the results are too variable'. Within the last two decades, however, largely as a result of the requirements of international environmental and food standards programmes, it has become increasingly apparent that a collaborative interlaboratory study is the only way to estimate the variability characteristics of methods of analysis as performed by the typical population of laboratories using the methods. To obtain a common basis for measuring the statistical characteristics of analytical methods, representatives of almost two dozen international organizations meeting in Geneva, in May 1987, approved by consensus a protocol for the design and interpretation of data from collaborative studies of chemical methods of analysis.

UI MeSH Term Description Entries
D011786 Quality Control A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed) Control, Quality,Controls, Quality,Quality Controls
D005504 Food Analysis Measurement and evaluation of the components of substances to be taken as FOOD. Analysis, Food,Analyses, Food,Food Analyses
D015203 Reproducibility of Results The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results. Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D015982 Bias Any deviation of results or inferences from the truth, or processes leading to such deviation. Bias can result from several sources: one-sided or systematic variations in measurement from the true value (systematic error); flaws in study design; deviation of inferences, interpretations, or analyses based on flawed data or data collection; etc. There is no sense of prejudice or subjectivity implied in the assessment of bias under these conditions. Aggregation Bias,Bias, Aggregation,Bias, Ecological,Bias, Statistical,Bias, Systematic,Ecological Bias,Outcome Measurement Errors,Statistical Bias,Systematic Bias,Bias, Epidemiologic,Biases,Biases, Ecological,Biases, Statistical,Ecological Biases,Ecological Fallacies,Ecological Fallacy,Epidemiologic Biases,Experimental Bias,Fallacies, Ecological,Fallacy, Ecological,Scientific Bias,Statistical Biases,Truncation Bias,Truncation Biases,Bias, Experimental,Bias, Scientific,Bias, Truncation,Biase, Epidemiologic,Biases, Epidemiologic,Biases, Truncation,Epidemiologic Biase,Error, Outcome Measurement,Errors, Outcome Measurement,Outcome Measurement Error
D015983 Selection Bias The introduction of error due to systematic differences in the characteristics between those selected and those not selected for a given study. In sampling bias, error is the result of failure to ensure that all members of the reference population have a known chance of selection in the sample. Bias, Selection,Sampling Bias,Sampling Biases,Sampling Error,Selection Biases,Bias, Sampling,Biases, Sampling,Biases, Selection,Error, Sampling,Errors, Sampling,Sampling Errors

Related Publications

W Horwitz
January 1993, Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences,
W Horwitz
October 2005, Gene therapy,
W Horwitz
January 2012, Profiles of drug substances, excipients, and related methodology,
W Horwitz
January 2016, International journal of pharmaceutical compounding,
W Horwitz
February 1987, Bollettino chimico farmaceutico,
W Horwitz
April 1998, Analytical chemistry,
W Horwitz
July 2007, Journal of chromatography. A,
Copied contents to your clipboard!