Analysis of recent pharmaceutical regulatory documents on analytical method validation

Rozet, Eric; Ceccato, Attilio; Hubert, Cédric; Ziémons, Eric; Oprean, Radu; Rudaz, Serge; Boulanger, Bruno; Hubert, Philippe

doi:10.1016/j.chroma.2007.03.111

Cited by 234 publications

(158 citation statements)

References 35 publications

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“…To evaluate the linearity of the method results, a linear regression line was fitted on the back-calculated concentrations of the validation standards [16,24,26]. The equations obtained and the coefficients of determination are shown in Table 1.…”

Section: Linearity Of the Resultsmentioning

confidence: 99%

“…Trueness, expressed in terms of relative bias (%), was calculated from the validation standards [16,24]. As can been seen in Table 1, trueness was acceptable (relative bias smaller than 10%) for both matrices serum and urine.…”

Section: Truenessmentioning

confidence: 95%

“…The response function is, within a certain range, the relationship between the response observed and the concentration of the analyte in the sample [24]. Thus, the selection of the calibration curve for the quantification of iohexol in the two matrices should be the fit for purpose response function [25].…”

Section: Response Functionmentioning

confidence: 99%

“…The precision of the method was determined by computing the Relative Standard Deviations (RSDs) for repeatability and timedifferent intermediate precision at each concentration level of the validation standards [16,24,26]. For serum and urine, the precision at each concentration level of the validation standards did not exceed 15% (Table 1).…”

Section: Precisionmentioning

confidence: 99%

“…Accuracy takes into account the total error (sum of the systematic and random errors) of the test results [16,24,26]. As shown in Table 1, the relative upper and lower β-expectation tolerance limits (%) did not exceed the acceptance limits (± 30%) for each concentration level and for both matrices.…”

Section: Accuracy Loq and Lodmentioning

confidence: 99%

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Performance of iohexol determination in serum and urine by HPLC: Validation, risk and uncertainty assessment

Cavalier

Rozet

Dubois

et al. 2008

Clinica Chimica Acta

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Background: Determination of glomerular filtration rate plays an important role in nephrological practice. Iohexol is a reference marker for glomerular filtration rate determination. It is available and safe. The aim of this study was to develop a simple, efficient and easy to use analytical method for the quantification of iohexol in serum and urine by high performance liquid chromatography and to thoroughly validate this method. Methods: The HPLC method was inspired from the method published by Krutzen. The e.noval software V2.0 (Arlenda, Liège, Belgium) was used to compute all validation results. Results: The validation results indicate that the method will give accurate and reliable results for serum values ranging from 12.95 to 1295 μg/ml and for urine values ranging from 86.0 to 4144 μg/ml. In routine practice, iohexol concentrations found in plasma after injection range from 40 to 600 μg/ml. The expected urinary values are much wider. One should not hesitate to dilute urine samples to fit with the validated range over 5000 μg/ml. Conclusion: This is the first time that a reference method for the determination of GFR is validated with such a rigorous and thorough protocol. Contrary to other GFR markers, iohexol is now strongly validated from an analytical point of view.

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Section: Linearity Of the Resultsmentioning

confidence: 99%

Section: Truenessmentioning

confidence: 95%