Validation protocol and analytical quality in biological monitoring of occupational exposure to antineoplastic drugs

Roberta Turci, Cristina Sottani, Rudolf Schierl, Claudio Minoia

Research output: Contribution to journalArticle

Abstract

Occupational exposure to antineoplastic cytostatic drugs has been recognized as a potential health hazard since the seventies. Safety guidelines and recommendations have been published in several countries in order to improve operating procedures and keep exposure levels as low as possible. Nevertheless, contamination still occurs. With a view to preventing exposure, standardized authorized methods and a mandatory monitoring system appear to be an essential prerequisite. First of all, reliable analytical methods are necessary, and a wide number of drugs should be monitored, on the basis of the continual change in the treatment protocols. In fact, most of the methods available in the literature were not properly validated, and a lack of details concerning quality assurance is clearly observed. When assessing analytical methods applied for routine testing, validation studies are of utmost importance. Not only performance parameters, such as sensitivity, specificity, LOD and LLQ, should therefore be determined, but also the uncertainty of measurement, which gives a measure of the confidence that can be placed on the results.

Original languageEnglish
Pages (from-to)256-262
Number of pages7
JournalToxicology Letters
Volume162
Issue number2-3 SPEC. ISS.
DOIs
Publication statusPublished - Apr 10 2006

Fingerprint

Health hazards
Environmental Monitoring
Cytostatic Agents
Occupational Exposure
Quality assurance
Antineoplastic Agents
Contamination
Monitoring
Testing
Pharmaceutical Preparations
Validation Studies
Clinical Protocols
Uncertainty
Guidelines
Safety
Sensitivity and Specificity
Health

Keywords

  • Antineoplastic drugs
  • Biological monitoring
  • Quality assurance
  • Uncertainty of measurement

ASJC Scopus subject areas

  • Toxicology

Cite this

Validation protocol and analytical quality in biological monitoring of occupational exposure to antineoplastic drugs. / Turci, Roberta; Sottani, Cristina; Schierl, Rudolf; Minoia, Claudio.

In: Toxicology Letters, Vol. 162, No. 2-3 SPEC. ISS., 10.04.2006, p. 256-262.

Research output: Contribution to journalArticle

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