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  1. Article ; Online: Development, validation and application of a liquid chromatography-tandem mass spectrometry method for quantifying lurasidone in dried blood spot samples.

    Rajadhyaksha, Madhura / Londhe, Vaishali

    Bioanalysis

    2023  Volume 15, Issue 24, Page(s) 1503–1517

    Abstract: Background: ...

    Abstract Background:
    MeSH term(s) Rats ; Animals ; Lurasidone Hydrochloride ; Tandem Mass Spectrometry/methods ; Dried Blood Spot Testing/methods ; Reproducibility of Results ; Chromatography, Liquid/methods ; Chromatography, High Pressure Liquid
    Chemical Substances Lurasidone Hydrochloride (O0P4I5851I)
    Language English
    Publishing date 2023-11-22
    Publishing country England
    Document type Journal Article
    ISSN 1757-6199
    ISSN (online) 1757-6199
    DOI 10.4155/bio-2023-0142
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Bioanalytical liquid chromatography-tandem mass spectrometry method development and validation for quantification of lurasidone in rat plasma using ion pairing agent.

    Rajadhyaksha, Madhura / Londhe, Vaishali

    Biomedical chromatography : BMC

    2023  Volume 38, Issue 1, Page(s) e5764

    Abstract: A bioanalytical method was developed and validated for determining lurasidone (LUR) in rat plasma. The analyte and internal standard were extracted from rat plasma using a liquid-liquid extraction method. The mobile phase consisted of methanol, ... ...

    Abstract A bioanalytical method was developed and validated for determining lurasidone (LUR) in rat plasma. The analyte and internal standard were extracted from rat plasma using a liquid-liquid extraction method. The mobile phase consisted of methanol, acetonitrile and water, with an ion pairing agent, 0.1% heptafluorobutyric acid, added to minimise the matrix effect. The detection was achieved using a tandem mass spectrometer (API 2000) in positive ion multiple reaction monitoring mode. All parameters were validated, including selectivity, specificity, carry-over effect, linearity, precision, accuracy, matrix effect, sensitivity and stability. The linearity range was from 5.0 to 1200.0 ng/mL with a correlation coefficient of >0.99. The accuracy ranged from 100.00% to 110.22% across the quality control range. The mean absolute recovery from matrix samples for LUR and the internal standard was found to be 68.46% and 67.25%, respectively, and the relative recovery was found to be 73.89% and 77.44%, respectively. This method can determine LUR concentrations in rat plasma samples up to 12 h after oral administration, aiding in LUR pharmacokinetic (PK) investigations in rats. The method's reproducibility on a conventional LC-MS/MS system and a shorter run time of 3.0 min make it an appealing bioanalytical method for quantifying LUR in PK studies.
    MeSH term(s) Rats ; Animals ; Chromatography, Liquid ; Tandem Mass Spectrometry/methods ; Lurasidone Hydrochloride ; Chromatography, High Pressure Liquid/methods ; Reproducibility of Results
    Chemical Substances Lurasidone Hydrochloride (O0P4I5851I)
    Language English
    Publishing date 2023-11-08
    Publishing country England
    Document type Journal Article
    ZDB-ID 632848-9
    ISSN 1099-0801 ; 0269-3879
    ISSN (online) 1099-0801
    ISSN 0269-3879
    DOI 10.1002/bmc.5764
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 2166: Show issues Location:
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  3. Article ; Online: Pertinence of microsampling in various nonclinical and clinical studies: the ICH perspective.

    Londhe, Vaishali / Rajadhyaksha, Madhura

    Bioanalysis

    2022  Volume 14, Issue 17, Page(s) 1137–1139

    MeSH term(s) Dried Blood Spot Testing ; Blood Specimen Collection
    Language English
    Publishing date 2022-09-16
    Publishing country England
    Document type Editorial
    ISSN 1757-6199
    ISSN (online) 1757-6199
    DOI 10.4155/bio-2022-0163
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Microsampling: A role to play in Covid-19 diagnosis, surveillance, treatment and clinical trials.

    Rajadhyaksha, Madhura / Londhe, Vaishali

    Drug testing and analysis

    2021  Volume 13, Issue 7, Page(s) 1238–1248

    Abstract: The outbreak of the new coronavirus disease changed the world upside down. Every day, millions of people were subjected to diagnostic testing for Covid-19, all over the world. Molecular tests helped in the diagnosis of current infection by detecting the ... ...

    Abstract The outbreak of the new coronavirus disease changed the world upside down. Every day, millions of people were subjected to diagnostic testing for Covid-19, all over the world. Molecular tests helped in the diagnosis of current infection by detecting the presence of viral genome whereas serological tests helped in detecting the presence of antibody in blood as well as contributed to vaccine development. This testing helped in understanding the immunogenicity, community prevalence, geographical spread and conditions post-infection. However, with the contagious nature of the virus, biological specimen sampling involved the risk of transmission and spread of infection. Clinic or pathology visit was the most concerning part. Trained personnel and resources was another barrier. In this scenario, microsampling played an important role due to its most important advantage of remote, contactless, small volume and self-sampling. Minimum requirements for sample storage and ease of shipment added value in this situation. The highly sensitive instruments and validated assay formats assured the accuracy of results and stability of samples. Microsampling techniques are contributing effectively to the Covid-19 pandemic by reducing the demand for clinical staff in population-level testing. The validated and established applications supported the use of microsampling in diagnosis, therapeutic drug monitoring, development of treatment or vaccines and clinical trials for Covid-19.
    MeSH term(s) Antiviral Agents/therapeutic use ; COVID-19/diagnosis ; COVID-19/drug therapy ; COVID-19 Testing ; COVID-19 Vaccines/therapeutic use ; Clinical Trials as Topic ; Drug Monitoring ; Humans ; Population Surveillance ; Predictive Value of Tests ; Specimen Handling
    Chemical Substances Antiviral Agents ; COVID-19 Vaccines
    Language English
    Publishing date 2021-06-15
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2462336-2
    ISSN 1942-7611 ; 1942-7603
    ISSN (online) 1942-7611
    ISSN 1942-7603
    DOI 10.1002/dta.3107
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 6792: Show issues Location:
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  5. Article ; Online: Opportunities and obstacles for microsampling techniques in bioanalysis: Special focus on DBS and VAMS.

    Londhe, Vaishali / Rajadhyaksha, Madhura

    Journal of pharmaceutical and biomedical analysis

    2020  Volume 182, Page(s) 113102

    Abstract: Microsampling, a reduced volume (< 50 μl) sampling method has successfully gained attention at the International Conference on Harmonization (ICH) level. It has been reflected in a few guidelines like ICH SA3, S11 and M10. The established benefits of ... ...

    Abstract Microsampling, a reduced volume (< 50 μl) sampling method has successfully gained attention at the International Conference on Harmonization (ICH) level. It has been reflected in a few guidelines like ICH SA3, S11 and M10. The established benefits of microsampling support its use in Toxicokinetic (TK) and Pharmacokinetic (PK) studies, clinical studies, neonate sampling and remote sampling. When designing the TK component of a juvenile animal study, microsampling and sparse sampling (if justified) are strongly encouraged from the view of 3Rs (Replace, Refine, and Reduce). The novel sampling techniques arose with benefits over conventional sampling in terms of ease of sampling, storage, and shipment. These improved sampling techniques are less invasive and preferred by patients and trial participants. For the acceptance of these techniques in regulated bioanalysis, it is essential to prove its suitability with a robust and reliable method. Though there are many opportunities for the newer and smarter microsampling devices, the major obstacles are hematocrit influence, homogeneity of samples, repeats, incurred samples reanalysis and regulatory acceptance. With the advancement in techniques, opportunities are marching ahead of obstacles. The two microsampling techniques Dried Blood Spot (DBS) and Volumetric Absorption Microsampling (VAMS) are studied and elaborated in this article with respect to bioanalytical consideration, method validation and regulatory perspectives on its acceptance in regulated bioanalysis.
    MeSH term(s) Animals ; Blood Specimen Collection/methods ; Dried Blood Spot Testing/methods ; Humans ; Infant, Newborn ; Pharmacokinetics ; Research Design ; Specimen Handling/methods ; Toxicokinetics
    Language English
    Publishing date 2020-01-25
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 604917-5
    ISSN 1873-264X ; 0731-7085
    ISSN (online) 1873-264X
    ISSN 0731-7085
    DOI 10.1016/j.jpba.2020.113102
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 1850: Show issues Location:
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