PubMed Health⌕ Search
Home/Archive/PubMed

PubMed · 7920558

[Analytical validation in compendium methods].

N Kaniwa·R Matsuda·M Ishibashi
View original source ↗Export metadata ↓

Abstract

Well validated analytical methods should be used in official tests in order to eliminate the type I and II errors. The analytical validation is the process to confirm that the performance characteristics of a proposed analytical method is adequate for its intended use. The performance characteristics of an analytical method are validated by evaluating that observed analytical performance parameters of the analytical method meet the criteria required by a test to which the analytical method is applied. Basic rules in analytical validation were described in this report. The more strict rules for determination of the limit of detection and the test of precision than usually applied were proposed.

Explore related subjects

Chemistry Techniques, AnalyticalReproducibility of ResultsEnglish AbstractJournal Article

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

N Kaniwa, R Matsuda, M Ishibashi. 1993. [Analytical validation in compendium methods].. https://pubmed.ncbi.nlm.nih.gov/7920558/

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

PubMed1997

Injection of ultrasmall samples and single molecules into tapered capillaries.

A novel injection scheme is described in which ultrasmall samples in the attoliter (10(-18) L) and low femtoliter (10(-15) L) range, or even single molecules, are controllably introduced into a tapered capillary so that electrophoretic separation can be carried out. To match the dimensions of the capillary inlet with that of the sample, capillary tips are tapered to an inside diameter ranging from hundreds of nanometers to a few micrometers. To inject an ultrasmall sample, optical trapping is used to immobilize and manipulate the sample in order to place it inside or next to the capillary inlet. A small controlled suction results in the loading of the sample into the capillary.

Chemistry Techniques, Analytical↗
PubMed1997

Drug screening in biological fluids. The need for a systematic approach.

In this paper the key steps towards drug screening in biological fluids are considered: (i) sample work up-isolation-concentration; (ii) differentiation-detection; (iii) identification. For (i) solid-phase extraction has very good potential; for (ii) thin-layer chromatography, gas chromatography and high-performance liquid chromatography, in combination with their respective detection modes, each have their particular advantages and disadvantages; for (iii) extensive computerized data bases are essential. It is emphasized that each step must be approached and carried out in a systematic way, not only to make sure that all substances of interest can be detected, but also for their correct identification. To this end all analytical procedures and techniques used require extensive validation of their detection and identification properties.

Chemistry Techniques, Analytical↗
PubMed1997

Polymer- versus silica-based separation media: elimination of nonspecific interactions in the chiral recognition process through functional polymer design.

A novel chiral stationary phase that contains a new chiral selector based on L-valine-3,5-dimethylanilide attached to monodisperse poly(glycidyl methacrylate-co-ethylene dimethacrylate) beads has been prepared. The polymeric separation medium provides greatly enhanced enantioselectivities and reduced retention times when compared to the analogous silica-based chiral stationary phase in the separation of the enantiomers of 3,5-dinitrobenzamido derivatives of alpha-amino acids under normal-phase HPLC conditions. Separation factors (alpha) of up to 7 were achieved with the polymeric separation medium, which is also useful for the separation of large samples under overload conditions.

Chemistry Techniques, Analytical↗