The transfer of analytical procedures

Ermer, Joachim; Limberger, Markus; Lis, Katarzyna; Wätzig, Hermann

doi:10.1016/j.jpba.2013.07.009

Cited by 20 publications

(18 citation statements)

References 11 publications

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“…While such assessments may reflect inter-laboratory variation, the assessment of reproducibility requires the transfer [81, 82] and testing of a dedicated analytical procedure with homogeneous materials [49] as opposed to round-robin audits of non-standardised procedures among laboratories [79]. The latter provides little information on the source of variation or on the condition-specific measurement of precision required for the evaluation of reproducibility.…”

Section: Validation Characteristics For Analytical Proceduresmentioning

confidence: 99%

Developing Robust Standardised Analytical Procedures for Cannabinoid Quantification: Laying the Foundations for an Emerging Cannabis-Based Pharmaceutical Industry

Welling¹,

Liu²,

Hazekamp³

et al. 2019

Med Cannabis Cannabinoids

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The plant genus Cannabis is a prolific producer of unique pharmaceutically relevant metabolites, commonly referred to as cannabinoids. Robust and standardised methods for the quantification of cannabinoids within botanical and drug forms is a critical step forward for an emerging Cannabis-based pharmaceutical industry, which is poised for rapid expansion. Despite a growing body of analytical methods for the quantification of cannabinoids, few have been validated using internationally accredited guidelines. Moreover, standardised methods have yet to be developed for application at various stages of manufacture as well as for different levels of processing and refinement. Validation parameters for establishing robust standardised methods for cannabinoid quantification within Cannabis-based drug forms are critically discussed. Determining an appropriate level of specificity (discrimination) among heterogeneous botanical matrices as well as evaluating accuracy (recovery) and inter-laboratory precision (reproducibility) within strict and volatile regulatory environments are potential obstacles to the establishment of robust analytical procedures. We argue that while some of these challenges remain unique to Cannabis, others are common to botanical-based drug development and manufacture. In order to address potential barriers to analytical method standardisation, a collaborative research initiative inclusive of academic and commercial stakeholders is proposed.

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Section: Validation Characteristics For Analytical Proceduresmentioning

confidence: 99%

Developing Robust Standardised Analytical Procedures for Cannabinoid Quantification: Laying the Foundations for an Emerging Cannabis-Based Pharmaceutical Industry

Welling¹,

Liu²,

Hazekamp³

et al. 2019

Med Cannabis Cannabinoids

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“…The most common approaches for AMT are comparative testing, covalidation involving two or more laboratories, revalidation and transfer waiver (Agut, Caron, Giordano, Hoffman, & Ségalini, 2011;Ermer, Limberger, Lis, & Wätzig, 2013).…”

Section: Introductionmentioning

confidence: 99%

Transfer of high performance liquid chromatography with diode array detection method for determination in serum of psychotropic drugs

Hahirwa

Charlier

Karangwa

et al. 2017

RWJour

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Background: The relevance of the determination of blood concentration levels of psychotropic drugs has been demonstrated in Rwanda. However, due to the lack of appropriate analytical methods, such activity is not carried out in this country. Objective: The aim of this work was to transfer to a Rwandan laboratory a High Performance Liquid Chromatography based method, applicable for the determination in serum of psychotropic drugs commonly prescribed in Rwanda. Method: Liquid-liquid extraction using prazepam as internal standard was used for sample preparation. Chromatographic separation was performed on a Symmetry C8 analytical column, using acetonitrile and a phosphate buffer as mobile phase. The method was validated with respect to total error concept as decision criterion. Results: The validated method was linear over tested dosing intervals with a coefficient of determination greater than 0.99 for all analytes. The precision was good with RSD between 1.3 and 15.6% and the trueness ranged between 87 and 109%.The accuracy of the method was demonstrated as well. Conclusion: The analytical method allowing a simultaneous determination in serum of several antipsychotropic drugs was successfully validated and thus transferred to the Laboratory of Analysis of Foodstuffs, Drugs, Water and Toxics (Rwanda).

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“…Samples of commercial production batches are recommended to be used [5,[8][9][10][11][12][13] as testing materials. Samples from at least one batch are recommended to be tested [4,[9][10][11][12].With regard to the study designs, method transfer studies should evaluate the impact of factors including analysts, days, number of runs, equipment (brand and/or model), environment and reagent suppliers on the results obtained in the sending and receiving laboratories, using the same testing materials. Wieling proposed to keep the methods, chemicals, reagents, disposables, glassware, equipment (brand and model) and data reduction as identical as possible [6].…”

mentioning

confidence: 99%

“…While the US FDA guidance to industry [1,2] and further publications [3][4][5][6][7][8][9][10][11][12][13][14][15] discuss the general principles for the design, analysis and evaluation of method transfer studies, they do not explicitly specify the acceptance criteria by which assay transfers are considered acceptable. Although these general principles apply to the majority of assay transfer studies, depending on the type and the intended purpose of the assays, different statistical analysis methods have been proposed to suit specific needs.…”

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confidence: 99%

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Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products

Shen

2017

Bioanalysis

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During biotechnology product development, the analytical instrumentation and methodology are often carefully selected based on the intended purpose and the scope of the analytical method. Specifically, parameters such as specificity, linearity, limit of detection (LOD) and limit of qualification (LOQ), range, accuracy and precision are evaluated [1]. After an analytical method is successfully validated and implemented, the updates of the method with the standard operating procedure will be conducted during the life-cycle of the product. The life-cycle management of analytical methods includes, but is not limited to, the following:• trend analyses of the method performance at regular intervals;• evaluation of the need to optimize the analytical method by requalification or even revalidation of all or a part of the analytical procedure due to any proposed changes (e.g., critical raw material supplier change);• development and validation of a new or an alternative analytical method for a new impurity;• transferring a validated analytical method from a sending laboratory to a testing laboratory.A method transfer is common practice during the life-cycle management of pharmaceutical products. Since the analytical method to be transferred has been already thoroughly evaluated and fully validated for its intended purpose at the sending laboratory, the main purpose of method transfer studies is usually the qualification to evaluate if the two laboratories generate comparable results across the parameter ranges of interest, and to assure that the method after the transfer is still suitable for its intended use.While the US FDA guidance to industry [1,2] and further publications [3][4][5][6][7][8][9][10][11][12][13][14][15] discuss the general principles for the design, analysis and evaluation of method transfer studies, they do not explicitly specify the acceptance criteria by which assay transfers are considered acceptable. Although these general principles apply to the majority of assay transfer studies, depending on the type and the intended purpose of the assays, different statistical analysis methods have been proposed to suit specific needs. Below, we briefly summarize published proposals with regard to testing materials, study [6,7]. Wieling [6] proposed to split the sample into two subsets. Lin et al. [7] recommended that bioanalytical methods use the incurred samples or a set of QC samples prepared to cover the low, medium and high concentrations in both laboratories. Samples of commercial production batches are recommended to be used [5,[8][9][10][11][12][13] as testing materials. Samples from at least one batch are recommended to be tested [4,[9][10][11][12].With regard to the study designs, method transfer studies should evaluate the impact of factors including analysts, days, number of runs, equipment (brand and/or model), environment and reagent suppliers on the results obtained in the sending and receiving laboratories, using the same testing materials. Wieling proposed to keep the methods, chemicals, rea...

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The transfer of analytical procedures

Cited by 20 publications

References 11 publications

Developing Robust Standardised Analytical Procedures for Cannabinoid Quantification: Laying the Foundations for an Emerging Cannabis-Based Pharmaceutical Industry

Developing Robust Standardised Analytical Procedures for Cannabinoid Quantification: Laying the Foundations for an Emerging Cannabis-Based Pharmaceutical Industry

Transfer of high performance liquid chromatography with diode array detection method for determination in serum of psychotropic drugs

Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products

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