Clinical chemistry is subject to the same principles and standards used in all branches of metrology in chemistry for validation of measurement methods. The use of measuring systems in clinical chemistry is, however, of exceptionally high volume, diverse and involves many laboratories and systems. Samples for measuring the same measurand from a certain patient are likely to encounter several me...

High performance liquid chromatography (HPLC) is an integral analytical tool in assessing drug product stability. HPLC methods should be able to separate, detect, and quantify the various drug-related degradants that can form on storage or manufacturing, plus detect and quantify any drug-related impurities that may be introduced during synthesis. Forced degradation studies of new chemical entit...

Antenna calibration measurement is a specific type of multidimensional measurement with a plenty of influencing factors. In order to validate these measurements, the specialized methodology with a goal of improving the calibration procedures has been developed. The method is based on cluster analysis of existing antenna calibration measurements in a combination with tailored outlier detection m...

Today, the main issue is to answer the following question: have we finally recognized that when it comes to software, the delivery of absolute numerical safety targets is considered to be impossible, and the methods contained in the CENELEC standard produce a “probability” that certain unsafe failure rates will be archived, rather than an absolute assurance? We know that checks that are underta...

Pharmacopeial microbiological tests detect and/or enumerate microbes that replicate in the presence of microbiological media. The challenge presented by adopting modern rapid microbiological methods is determining whether or not they represent the automation of a current compendial method or if they represent an “alternative” to a compendial method. The answer impacts how a firm should qualify ...

the dna microarray is an important technique that allows researchers to analyze many gene expression data in parallel. although the data can be more significant if they come out of separate experiments, one of the most challenging phases in the microarray context is the integration of separate expression level datasets that have gathered through different techniques. in this paper, we present a...

The validation of a test method is the process by which the relevance and reliability of the method are assessed for a particular purpose. It is an essential stage in the evolution of the method from its development to its acceptance and application for regulatory purposes. The principles according to which alternative tests should be validated have been agreed upon at an international level, a...