Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal

Hubert, Philippe; Nguyen-Huu, J.-J.; Boulanger, Bruno; Chapuzet, E.; Cohen, Nadine; Compagnon, P.-A.; Dewé, Walthère; Feinberg, Max; Laurentie, Michel; Mercier, N.; Muzard, G.; Valat, L.; Rozet, Eric

doi:10.1016/j.jpba.2008.07.018

Cited by 188 publications

(194 citation statements)

References 34 publications

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“…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%

“…It therefore refers to total measurement error. Trueness refers to "the closeness of agreement between the average value obtained from a large series of test results and an accepted reference value" [15,16,19]. This concept is therefore related to the systematic error of a measurement process.…”

Section: Terminologymentioning

confidence: 99%

“…From the results obtained, the concentrations of the validation standards were back-calculated to determine the mean relative bias, the standard deviation for intermediate precision and finally the upper and lower β-expectation tolerance limits at 95% level [16,26].…”

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%

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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: Truenessmentioning

confidence: 95%

Section: Terminologymentioning

confidence: 99%

Section: Response Functionmentioning

confidence: 99%

Section: Precisionmentioning

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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“…The validation samples mappings were then analyzed with the PLS model and the mean predicted concentration of each map was used to validate the model. This method has been validated using the "total error" approach in accordance with the validation requirements in the ICH Q2 R1 norm (Hubert et al, 2008(Hubert et al, , 2007a(Hubert et al, , 2007b(Hubert et al, , 2004.…”

Section: Quantitative Modelmentioning

confidence: 99%

Thorough characterization of a Self-Emulsifying Drug Delivery System with Raman hyperspectral imaging: A case study

Sacré

Netchacovitch

Bleye

et al. 2015

International Journal of Pharmaceutics

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Newly developed drugs often have poor bioavailability due to their poor water solubility (BCS class 2 drugs). It is therefore necessary to develop new strategies to enhance their solubility and their activity, among which, Self-Emulsifying Drug Delivery System (SEDDS).The efficacy of the drugs contained in these preparations is mainly affected by the solid state and the particle size of the active pharmaceutical ingredient (API).However, it is quite complex, long and expensive to characterize these parameters with classical techniques such as X-Ray powder diffraction, differential scanning calorimetry or hot stage microscopy.The present article presents, through a case study, the advantages of the Raman hyperspectral imaging in the characterization of such formulations. Indeed, Raman chemical imaging may fully characterize SEDDS with single equipment and operator in a non-destructive way allowing the follow-up of the formulation during stability studies. Raman imaging is therefore a tool of choice in the PAT framework since it increases the knowledge of the formulation and the process. 2A quantitative multivariate method using Raman hyperspectral imaging to assay the API in the lipid based formulation has been developed and fully validated following the "total error" approach.

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Method Performance Characteristics

Ermer

2014

Method Validation in Pharmaceutical Analysis

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Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal

Cited by 188 publications

References 34 publications

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

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

Thorough characterization of a Self-Emulsifying Drug Delivery System with Raman hyperspectral imaging: A case study

Method Performance Characteristics

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