Pertinence of microsampling in various nonclinical and clinical studies: the ICH perspective

Londhe, Vaishali; Rajadhyaksha, Madhura

doi:10.4155/bio-2022-0163

Cited by 3 publications

(2 citation statements)

References 3 publications

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“…Making animal studies more ethical through the 3Rs can be achieved with microsampling, as it reduces stress, sampling time and the number of animals needed for studies 90 . Guidelines that consolidate the regulatory perspectives on microsampling and support its use in blood sampling have also been added to and reviewed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use 91 …”

Section: Applicationsmentioning

confidence: 99%

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Blood microsampling technologies: Innovations and applications in 2022

Thangavelu

Wouters

Kindt

et al. 2023

Analytical Science Advances

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With the development of highly sensitive bioanalytical techniques, the volume of samples necessary for accurate analysis has reduced. Microsampling, the process of obtaining small amounts of blood, has thus gained popularity as it offers minimal‐invasiveness, reduced logistical costs and biohazard risks while simultaneously showing increased sample stability and a potential for the decentralization of the approach and at‐home self‐sampling. Although the benefits of microsampling have been recognised, its adoption in clinical practice has been slow. Several microsampling technologies and devices are currently available and employed in research studies for various biomedical applications. This review provides an overview of the state‐of‐the‐art in microsampling technology with a focus on the latest developments and advancements in the field of microsampling. Research published in the year 2022, including studies (i) developing strategies for the quantitation of analytes in microsamples and (ii) bridging and comparing the interchangeability between matrices and choice of technology for a given application, is reviewed to assess the advantages, challenges and limitations of the current state of microsampling. Successful implementation of microsampling in routine clinical care requires continued efforts for standardization and harmonization. Microsampling has been shown to facilitate data‐rich studies and a patient‐centric approach to healthcare and is foreseen to play a central role in the future digital revolution of healthcare through continuous monitoring to improve the quality of life.

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Section: Applicationsmentioning

confidence: 99%

“… 90 Guidelines that consolidate the regulatory perspectives on microsampling and support its use in blood sampling have also been added to and reviewed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. 91 …”

Section: Applicationsmentioning

confidence: 99%

Blood microsampling technologies: Innovations and applications in 2022

Thangavelu

Wouters

Kindt

et al. 2023

Analytical Science Advances

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Pitfalls in bioanalytical work with a Japanese CRO or sponsor: from a project risk management perspective

2022

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Development, validation and application of a liquid chromatography–tandem mass spectrometry method for quantifying lurasidone in dried blood spot samples

Rajadhyaksha,

Londhe

2023

Bioanalysis

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Background: A liquid chromatography–tandem mass spectrometry method for quantifying lurasidone in rat dried blood spot (DBS) samples was developed. Method: The analyte was extracted from DBSs using the liquid–liquid extraction method. Chromatographic separation was achieved using a C18, Phenomenex, 150 × 4.6 mm, 3.0 μm column. The mobile phase composed of methanol, acetonitrile and water (70:10:20 v/v/v) with 0.1% heptafluorobutyric acid performed well in terms of reducing the matrix effect and achieving shorter retention time. Result: The method was validated over a concentration range of 5.0 to 1200.0 ng/ml and supported by the evaluation of various validation parameters. Conclusion: This simple, sensitive and specific method proved to be a viable alternative sampling method with reduced logistics and blood sample storage expenses despite analytical challenges.

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Pertinence of microsampling in various nonclinical and clinical studies: the ICH perspective

Cited by 3 publications

References 3 publications

Blood microsampling technologies: Innovations and applications in 2022

Blood microsampling technologies: Innovations and applications in 2022

Pitfalls in bioanalytical work with a Japanese CRO or sponsor: from a project risk management perspective

Development, validation and application of a liquid chromatography–tandem mass spectrometry method for quantifying lurasidone in dried blood spot samples

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