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During the last decade, it has become increasingly important that researchers demonstrate that research is conducted to the highest standards. The implementation of quality assurance for research laboratories will enable all fields of research and development to be judged impartially. There are no specific standards for research laboratories but where possible, existing standards can be adapted. This review is structured around two approaches. The first considers research to be a logical extension of testing, and it is assumed that testing standards can be applied methodically to each step in a research project. The second advocates a flexible approach, with research-specific criteria for assessing quality. The important papers published on this topic have been reviewed. The conclusions are that the general quality management approach, encompassed by the ISO 9000 series of standards with the emphasis on customer satisfaction and ‘fitness for purpose’, is suitable for implementing quality assurance in research laboratories.During the last decade, it has become increasingly important that researchers demonstrate that research is conducted to the highest standards. The implementation of quality assurance for research laboratories will enable all fields of research and development to be judged impartially. There are no specific standards for research laboratories but where possible, existing standards can be adapted. This review is structured around two approaches. The first considers research to be a logical extension of testing, and it is assumed that testing standards can be applied methodically to each step in a research project. The second advocates a flexible approach, with research-specific criteria for assessing quality. The important papers published on this topic have been reviewed. The conclusions are that the general quality management approach, encompassed by the ISO 9000 series of standards with the emphasis on customer satisfaction and ‘fitness for purpose’, is suitable for implementing quality assurance in research laboratories.

We have compared the reproducibility precisions provided by collaborative trials with precisions obtained from ruggedness tests specially designed to try to simulate between-laboratory variation. We found that the ruggedness tests underestimated the reproducibility variability consistently for those analytical methods requiring empirical calibration. The ruggedness tests provided on average a precision merely comparable with repeatability precision. This finding has implications for the estimation of uncertainty.

Summary: The systemic plasma pharmacokinetics of genistein were determined in rats to evaluate the absolute oral bioavailability and make comparison with similar data in the literature derived from humans subjects. The plasma concentrations of genistein, genistein glucuronide and carbon-14 were determined by LC-MS/MS and liquid scintillation counting following oral and intravenous dosing with [14C]genistein (4 mg kg−1 body weight). The absorption of total radioactivity from the gut, (parent compound and metabolites), was 56 and 111% in male and female rats, respectively. In contrast, the absolute oral bioavailability of genistein in male and female rats was 7 and 15%. There was a significant (P<0.001) difference between Cmax of genistein after intravenous (6921 and 4392 ng/ml) and oral (21 and 22 ng/ml) dosing in male and female rats, respectively. After oral administration, the concentration profile of genistein glucuronide in plasma greatly exceeded that of parent compound during the absorption/distribution phase suggesting extensive first pass metabolism, and provided evidence of entero-hepatic circulation. Selective plasma analysis by LC-MS/MS, without prior enzymatic hydrolysis, enabled ready discrimination between parent and conjugated metabolites and prevented gross overestimation of genistein bioavailability. Pharmacokinetic parameters Cmax, Tmax and AUC were similar to those reported in humans, which supports the use of the rat model for genistein toxicity studies.

As a means of assessing the performance of European laboratories who contribute analytical data on food contamination to the World Health Organization (WHO) Global Environmental Monitoring Scheme (GEMS), a series of five proficiency testing exercises were carried out during 1993 and 1994. In total 136 laboratories from 21 different countries took part in one or more of the exercises which covered the analysis of trace elements (lead, cadmium and mercury) in milk powder, pesticides (organochlorine, organophosphorus and pyrethroid) in spinach powder, nitrate in spinach powder, aflatoxins in nut-based animal feed and patulin in apple juices. The proficiency testing was carried out according to the ISO/IUPAC/AOAC INTERNATIONAL Harmonized Protocol and laboratories were awarded z-scores signifying their analytical capability based on their reported results for each of the respective exercises. Overall 60% of laboratories were satisfactory for accuracy for trace element analysis, 41% for pesticides, 43% for nitrate, 88% for aflatoxins and 53% for patulin. These results gave an overall poorer performance (68%) than the average for other similar schemes (79%), indicating the need for care in collating data for such programmes as GEMS and the need for remedial measures to assist in improving performance.

Zusammenfassung Ein Modell eines ionischen N-Nitrosamins (N-Nitroso-N1N1-dimethylpiperaziniodid) wurde synthetisiert, um die entsprechende analytische Methode zur Prüfung des möglichen Auftretens von Verbindungen dieser Klasse in Lebensmitteln zu entwickeln. Es wird ein für die Analyse dieses Stoffes in biologischen Proben geeignetes Verfahren beschrieben, das auf der Zubereitung eines wäßrigen Extrakts, Ionenpaar-Extraktion in einem organischen Lösungsmittel, Trennung durch Hochleistungs-Flüssigkeitschromatographie und Nachweis mit Hilfe eines thermischen Energieanalysators beruht. Aus geräuchertem Fleisch mit einem Gehalt von 200 µg ionischem N-Nitrosamin/kg wurden im Durchschnitt 83% des Stoffes extrahiert, die Methode hat eine Nachweisgrenze von 50 µg/kg.