Life cycle management of analytical methods

Parr, Maria Kristina; Schmidt, Alexander H.

doi:10.1016/j.jpba.2017.06.020

Cited by 84 publications

(57 citation statements)

References 128 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%

“…This includes development of the analytical target profile which documents the requirements of the analytical procedure, an acceptable target level of uncertainty, as well as performance criteria required for validation [81]. Within this framework and as requested by ICH Q12 guidelines [81], a multivariate analytical quality-by-design (AQbD) approach could be implemented to inform development of robust analytical procedures and quality systems [86]. AQbD approaches can perform in silico robustness testing of critical method parameters (flow rate, column length, etc.)…”

Section: Collaborative Research Initiativementioning

confidence: 99%

“…early in the development of an analytical procedure, and this workflow has been successfully applied to retention modelling for the separation of cannabinoids [87]. AQbD approaches establish a method operable design region or design space to mitigate out-of-specification results associated with trial-and-error, one parameter at a time, optimisation-based approaches [81, 86]. The former approach reduces the requirement for large and potentially costly retrospective changes to the analytical procedure during method performance qualification stages.…”

Section: Collaborative Research Initiativementioning

confidence: 99%

“…Clearly, given the complexities associated with qualification of method performance as well as the design, validation and transfer contributing to life cycle management of an analytical procedure [81], the establishment of robust and standardised procedures for cannabinoid determinations in CME requires a collaborative effort. Logistically, research organisations that may be eligible to participate within such an initiative would (1) hold relevant legal authorisations to conduct research on Cannabis, (2) have access to germplasm and representative Cannabis materials as well as analytical reference standards for the purposes of method development, and (3) be in a position to receive and supply Cannabis materials from/to participating stakeholders nationally and/or internationally.…”

Section: Collaborative Research Initiativementioning

confidence: 99%

“…The success of such a collaboration will be reliant on an agreed and predefined analytical target profile, independent of a specific analytical technique [81, 86, 88]. Important topics to resolve include: defining what the analytical procedure is to measure [88], for example the complement of cannabinoids to be included [89] and expected interfering materials [49], as well as how transferrable the analytical method is among heterogeneous CME matrices.…”

Section: Collaborative Research Initiativementioning

confidence: 99%

See 4 more Smart Citations

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%

Section: Collaborative Research Initiativementioning

confidence: 99%

Section: Collaborative Research Initiativementioning

confidence: 99%

Section: Collaborative Research Initiativementioning

confidence: 99%

Section: Collaborative Research Initiativementioning

confidence: 99%

See 3 more Smart Citations

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

View full text Add to dashboard Cite

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Analysis of doping control samples using supercritical fluid chromatography‐tandem mass spectrometry: Ready for routine use

Wuest

Gavrilović

Cowan

et al. 2023

J of Separation Science

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Supercritical fluid chromatography is proving to be a good separation and sample preparation tool for various analytical applications and, as such, has gained the attention of the anti‐doping community. Here, the applicability of supercritical fluid chromatography hyphenated to tandem mass spectrometry for routine doping control analysis was tested. A multi‐analyte method was developed to cover 197 drugs and metabolites that are prohibited in sport. More than 1000 samples were analyzed by applying a “dilute and inject” approach after hydrolysis of glucuronide metabolites. Additionally, a comparison with routinely used liquid chromatography‐mass spectrometry was performed with 250 of the 1000 samples and a number of past positive anti‐doping samples. It revealed some features where supercritical fluid chromatography‐tandem mass spectrometry was found to be complementary or advantageous to liquid chromatography‐mass spectrometry for anti‐doping purposes, such as better retention of analytes that are poorly retained in reversed‐phase liquid chromatography. Our results suggest that supercritical fluid chromatography‐tandem mass spectrometry is sensitive (limit of detection <50% relevant minimum required performance level required by the World Anti‐Doping Agency for anti‐doping analysis), reproducible, robust, precise (analytes of interest area coefficient of variation <5%; retention time difference coefficient of variation <1%) and complementary to existing techniques currently used for routine analysis in the World Anti‐Doping Agency accredited laboratories.

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Analytical lifecycle management approach: Application to development of a reliable LC method for estimation of lacidipine

Panda

Bera

Acharjya

et al. 2019

Separation Science Plus

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Lack of quality analytical methods with assured robustness and reliability has always been a serious concern for drug regulatory agencies. In the present study, a contemporary approach of analytical life‐cycle management resulted in the robust and reliable chromatographic analysis of lacidipine at a retention time of 5.1 min on a C‐18 column. Method variables such as %acetonitrile, flow rate, and pH were optimized using the design of experiment approach and their effect on critical quality attributes was studied. The attributes of the present study were significantly influenced by %acetonitrile and flow of the mobile phase. The newly optimized method was validated for various parameters with values in accordance with federal guidance. The lifecycle approach proved to be beneficial for routine application with a potential of future bio‐analytical utility.

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Life cycle management of analytical methods

Cited by 84 publications

References 128 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

Analysis of doping control samples using supercritical fluid chromatography‐tandem mass spectrometry: Ready for routine use

Analytical lifecycle management approach: Application to development of a reliable LC method for estimation of lacidipine

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