Harmonization of strategies for the validation of quantitative analytical procedures

Hubert, Ph.; Nguyen-Huu, J.-J.; Boulanger, Bruno; Chapuzet, E.; Chiap, Patrice; Cohen, Nadine; Compagnon, P.-A.; Dewé, Walthère; Feinberg, Max; Lallier, M.; Laurentie, Michel; Mercier, N.; Muzard, G.; Nivet, C.; Valat, L.

doi:10.1016/j.jpba.2004.07.027

Cited by 120 publications

(165 citation statements)

References 28 publications

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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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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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show abstract

“…Too many validation procedures are limited to the calculation of statistical criteria and do not propose effective techniques to decide whether a method is capable of accurately quantifying an analyte. This approach, not only simplifies the validation process of an analytical method, but also allows the monitoring of risk related to its utilization [29].…”

Section: Statistical Processing: Accuracy Profilementioning

confidence: 99%

“…This validation procedure, well described in the literature [28,29,[41][42][43][44][45][46][47][48][49], can be summarized as follows:…”

Section: Statistical Processing: Accuracy Profilementioning

confidence: 99%

“…This procedure is a simple decision tool based on the notion of the total error (bias and standard deviation) of the method allowing the assessment of the method's validity. Thus, the procedure simplifies the validation approach of an analytical method [28,29]. The objective is to reach a known level of guarantee for the results produced during field experiments.…”

Section: Introductionmentioning

confidence: 99%

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Development and validation by accuracy profile of a method for the analysis of monoterpenes in indoor air by active sampling and thermal desorption-gas chromatography-mass spectrometry

Marlet

Lognay

2010

Talanta

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The technique of thermal desorption (TD)-GC/MS was evaluated for the measurement of monoterpenes in indoor air. The validation strategy was intentionally oriented towards routine use and the reliability of the method rather than extreme performance. For this reason, validation by accuracy profile was chosen. The accuracy profile procedure, which is based on the concept of total error (bias + standard deviation), guarantees that a known proportion of future results obtained with the method will be within acceptance limits. For all the compounds tested in the present study, α-pinene, α-terpineol, β-pinene, d-limonene, ∆ 3 -carene, camphene, 1,8-cineole, p-cymene, linalool, but not in the case of carvone, the accuracy profile procedure established that at least 95% of the future results obtained would be within the ±15% acceptance limits of the validated method over the whole defined concentration range. Other parameters, such as selectivity, recovery, repeatability, stability of the molecules of interest and the effect of temperature, were also determined. The performance of the described method was finally evaluated by the analysis of indoor air from new timber frame constructions.

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“…Focusing on rapid and affordable aspects, a short column (RP18, 100 mm x 4.6 mm (ID), 3.5µm (dp)) and low cost organic solvent (methanol) were used in gradient mode with 10 mM ammonium dihydrogen carbonate buffer or ammonium formate buffer as mobile phase. Prior to the use in routine analyses, one method was validated according to the total error approach taking into account the accuracy profile as decision tool [9] .…”

Section: Methodsmentioning

confidence: 99%

Application of design space optimization strategy to the development of LC methods for simultaneous analysis of 18 antiretroviral medicines and 4 major excipients used in various pharmaceutical formulations

Habyalimana

Mbinze

Yemoa

et al. 2017

Journal of Pharmaceutical and Biomedical Analysis

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Harmonization of strategies for the validation of quantitative analytical procedures

Cited by 120 publications

References 28 publications

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

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

Development and validation by accuracy profile of a method for the analysis of monoterpenes in indoor air by active sampling and thermal desorption-gas chromatography-mass spectrometry

Application of design space optimization strategy to the development of LC methods for simultaneous analysis of 18 antiretroviral medicines and 4 major excipients used in various pharmaceutical formulations

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