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  • 1
    Electronic Resource
    Electronic Resource
    Validation criteria for developing ion-selective membrane electrodes for analysis of pharmaceuticals (1998)
    Springer
    Accreditation and quality assurance 3 (1998), S. 194-196 
    Details
    ISSN: 1432-0517
    Keywords: Key words Ion-selective membrane electrodes ; Reliability of construction ; Reliability of analytical information ; Validation criteria ; Analysis of pharmaceuticals
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract  The problem of validation criteria for developing ion-selective membrane electrodes for the analysis of pharmaceuticals arises from the connection between the reliability of ion-selective membrane electrodes construction and the reliability of the analytical information. Liquid membrane selective electrodes are more suitable for validation than the solid variety. The influence of the stability of ion pair complexes from the membrane on various parameters (e.g. response, limit of detection, and selectivity) is discussed. Validation criteria are proposed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s007690050221
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  • 2
    Electronic Resource
    Electronic Resource
    Selectivity versus specificity in chromatographic analytical methods (2000)
    Springer
    Accreditation and quality assurance 5 (2000), S. 180-181 
    Details
    ISSN: 1432-0517
    Keywords: Key words Selectivity ; Specificity ; Chromatography
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract   Analytical chemists should be aware of the differences between selectivity and specificity. Few analytical methods, including the chromatographic analytical methods, are truly specific. The International Union of Pure and Applied Chemistry (IUPAC) recommends that specificity is the ultimate of selectivity, therefore, analysts should promote this concept and aim to achieve highly selective analytical methods.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s007690050440
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  • 3
    Electronic Resource
    Electronic Resource
    The traceability of analytical measurements (1997)
    Springer
    Accreditation and quality assurance 2 (1997), S. 11-17 
    Details
    ISSN: 1432-0517
    Keywords: Key words Traceability ; Quality ; Measurement uncertainty ; Spectrophotometric system
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract  Traceability to the System International (SI) is an important prerequisite for international comparability and uniformity of chemical measurements to ensure mutual recognition of the results. In theory, all measurements can be traced back to the seven base units of the SI. Although the traceability system works well for most physical measurements, in many analytical and in some spectrophotometric measurements this system is not satisfactory. This paper describes the particular and practical problems and the contribution of the Romanian National Institute of Metrology in this field. The paper discusses the following concepts: clearly defined targets in the form of requirement specification, knowledge of trueness and/or measurement uncertainty, and traceability through an unbroken chain of calibration to primary standards. Traceability and uncertainty being two concepts inherently coupled, two examples of assessment of the uncertainty of measurement results are given for two spectrophotometric methods currently used in chemical laboratories.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s007690050089
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  • 4
    Electronic Resource
    Electronic Resource
    Some practical aspects of the validation of photometric systems for clinical analyses (1997)
    Springer
    Accreditation and quality assurance 2 (1997), S. 186-192 
    Details
    ISSN: 1432-0517
    Keywords: Key words Traceability ; Quality ; Measurement ; uncertainty ; Clinical reference ; materials ; Clinical photometric ; system
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract  It is well known that erroneous data reported to a physician may strongly affect medical decision making. For routine clinical chemistry purposes, different instrumentation can be used to compare measurements of unknown samples with standard reference materials. Currently, acceptable limits of accuracy and precision are poorly defined in the field of clinical chemistry laboratories. In this article, problems associated with spectrophotometric measurements, both manual and automated, are discussed. The task of the validation of photometric systems for clinical analyses is currently of considerable interest. Some practical aspects of this validation and the use of reference materials for this activity in the national area are discussed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s007690050128
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  • 5
    Electronic Resource
    Electronic Resource
    Clinical reference materials for the validation of the performance of photometric systems used for clinical analyses (1997)
    Springer
    Accreditation and quality assurance 2 (1997), S. 375-380 
    Details
    ISSN: 1432-0517
    Keywords: Key words Clinical spectrophotometry ; Quality assurance ; Validation ; Reference materials ; Spectrophotometric standards
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract  There are a wide variety of spectrophotometric devices nowadays used in health services with various qualities of manufacture methods of measurement and metrological characteristics for performing the necessary measurements. Therefore, to meet the accuracy and repeatability requirements needed in medical diagnosis and treatment, the validation of the performance of such systems by clinical chemistry laboratories is essential. However, the validation of a spectrophotometric system for clinical analyses requires several reference materials, according to the end use of the measurement results. This paper discusses some characteristics required of the clinical reference materials needed and used by Romanian Institute of Metrology for validation work. Types of clinical reference materials developed in the national area for this purpose are also presented.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s007690050168
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  • 6
    Electronic Resource
    Electronic Resource
    Traceable measurements in clinical laboratories (1998)
    Springer
    Accreditation and quality assurance 3 (1998), S. 270-277 
    Details
    ISSN: 1432-0517
    Keywords: Key words Traceability ; Quality ; Measurement uncertainty ; Clinical reference materials ; Clinical photometric system
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract  Reliable, traceable and comparable measurements provide the rational basis for evaluation of the quality of a result and the starting point for recognized laboratory accreditation in any national area. Modern medical diagnostics and treatment involve rapidly rising numbers and types of clinical laboratory measurements, that are reliable. Therefore, the basic principles to be followed to assure the traceability of clinical measurements as required by the Romanian Laws of Metrology are reviewed. Main sources affecting the quality of the unbroken chain of calibrations that relate the measurements back to appropriate measurement standards are discussed. Examples of how to achieve traceable measurements in clinical laboratories are presented. Details of specific uses of reference materials, measuring instruments and standard measurement methods are also discussed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s007690050240
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  • 7
    Electronic Resource
    Electronic Resource
    Certification of herbal products: an urgent need for appropriate methods (2000)
    Springer
    Accreditation and quality assurance 5 (2000), S. 286-287 
    Details
    ISSN: 1432-0517
    Keywords: Key words Herbal products ; Validation ; Herbal reference standards ; Botanicals
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract  Analytical chemists should focus their attention on establishing validated analytical methods for herbal pharmaceutical formulations. Efforts should also be made to have the reference materials for herbal products both accessible and commercially available.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s007690000162
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  • 8
    Electronic Resource
    Electronic Resource
    Immunosensors in clinical analysis (2000)
    Springer
    Fresenius' journal of analytical chemistry 366 (2000), S. 659-668 
    Details
    ISSN: 1432-1130
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Clinical analysis requires methods of high reliability. The importance of immunosensors in clinical analysis is discussed. Due to the fact that the construction of immunosensors plays a very important role in their response characteristics, different types of immunosensor designs are highlighted. The performances of immunosensors are discussed taking into account the type of transducer utilized for construction.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002160051560
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  • 9
    Electronic Resource
    Electronic Resource
    Amperometric biosensor based on D-aminoacid oxidase for the R-perindopril assay (2000)
    Springer
    Fresenius' journal of analytical chemistry 367 (2000), S. 178-180 
    Details
    ISSN: 1432-1130
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract A new amperometric biosensor based on D-aminoacid oxidase is described for the assay of R-perindopril. R-perindopril can be determined in the 400–¶20 nmol/L concentration range; the detection limit is ¶10 nmol/L. The selectivity was checked with S-perindopril, D- and L-proline, and polyvinylpyrrolidone. The main interfering species was D-proline. An automated system for the assay of R-perindopril based on the concept of flow injection with an amperometric biosensor (based on D-aminoacid oxidase) as detector is also described. The system is suitable for the on-line monitoring of R-perindopril at a sampling rate of 72 samples/h, in the linear range: 100 nmol/L –20 nmol/L with an RSD better than 0.09% (n = 10).
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002160051620
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  • 10
    Electronic Resource
    Electronic Resource
    Determination of pindolol in pharmaceutical formulations by gas chromatography (1982)
    Springer
    Chromatographia 15 (1982), S. 48-48 
    Details
    ISSN: 1612-1112
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02269041
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