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Aim: This study aimed to develop a colorimetric approach for quantifying ethanol using smartphone image analysis. Method: This research presents a straightforward smartphone-based colorimetric sensor that efficiently measures ethanol levels in exhaled breath condensate (EBC) samples. The process involved changing the acidic dichromate color in an ethanolic solution, followed by image analysis. Results: The results […]

The EU In Vitro Diagnostic Medical Devices Regulation (IVDR) [1] was published on 5 April 2017, becoming applicable on 26 May 2022. At first, the European Bioanalysis Forum (EBF) was not concerned whether the regulations would impact the work in regulated bioanalytical laboratories, as it was our interpretation that the regulated bioanalysis community would only

Background: The Bicycle® toxin conjugate BT5528 is a novel peptide therapeutic conjugated to the cytotoxic agent monomethyl auristatin E (MMAE). A bioanalytical assay was developed to quantify BT5528 and unconjugated MMAE in human plasma. Methodology: BT5528 quantitation used a protein precipitation procedure followed by LC–MS/MS detection. Quantitation of MMAE required a selective offline and online solid-phase extraction with detection

Chongwoo Yu , Wenlei Jiang , Murali Matta  Rong Wang , Sam Haidar& Hyeonglim Seo  Abstract Endogenous therapeutic analytes include hormones, neurotransmitters, vitamins, fatty acids and inorganic elements that are naturally present in the body because either the body produces them or they are present in the normal diet. The accurate measurement of endogenous therapeutic analytes poses a challenge when the administered exogenous

Joseph A Tweed , Fern Adams-Dam , Jane Allanson , Kevin Holmes , Ryan Senior , Hongmei Xu  Mengyao Li , Gavin Bennett & Phil Jeffrey  Abstract Background: The Bicycle® toxin conjugate BT5528 is a novel peptide therapeutic conjugated to the cytotoxic agent monomethyl auristatin E (MMAE). A bioanalytical assay was developed to quantify BT5528 and unconjugated MMAE in human plasma. Methodology: BT5528 quantitation used a protein precipitation procedure followed by LC–MS/MS detection. Quantitation

Divya Chauhan , Shailesh Dadge, Pavan K Yadav , Nazneen Sultana , Arun Agarwal, Sachin Vishwakarma, Shivam Rathaur, Shubhi Yadav, Manish K Chourasia & Jiaur R Gayen  Abstract Aim: A newer LC–MS/MS method was developed and validated for the simultaneous quantification of raloxifene (RL) and cladrin (CL). Methodology: Both drugs were resolved in RP-18 (4.6 × 50 mm, 5 μ) Xbridge Shield column using acetonitrile and 0.1% aqueous solution of formic acid (FA) (70:30% v/v) as mobile phase

Alejandro R Foley , Gizette Sperinde& Saloumeh K Fischer Abstract Antibody therapeutic levels in neurodegenerative diseases are often measured in both serum and cerebrospinal fluid (CSF). Due to 0.1% drug partition from serum to CSF and the higher sensitivity needs, usually two different assays are required. The different Gyrolab Bioaffy compact discs can extend the dynamic range of

Yasaman Sefid-Sefidehkhan , Maryam Khoshkam , Samineh Raha, Fariba Pourkarim , Abolghasem Jouyban , Maryam Khoubnasabjafari , Vahid Jouyban-Gharamaleki & Elaheh Rahimpour  Abstract Aim: This study aimed to develop a colorimetric approach for quantifying ethanol using smartphone image analysis. Method: This research presents a straightforward smartphone-based colorimetric sensor that efficiently measures ethanol levels in exhaled breath condensate (EBC) samples. The process involved changing the acidic dichromate color in an ethanolic solution,

Philip Timmerman, Anna Laurén, Robert Nelson & Matthew Barfield Keywords: The EU In Vitro Diagnostic Medical Devices Regulation (IVDR) [1] was published on 5 April 2017, becoming applicable on 26 May 2022. At first, the European Bioanalysis Forum (EBF) was not concerned whether the regulations would impact the work in regulated bioanalytical laboratories, as it was our interpretation that the regulated

Philip Denniff& Neil Spooner Abstract Background: As hematocrit levels are known to vary between individuals and with disease state, its effect on the physical characteristics of dried blood spot (DBS) samples and on the accurate quantification of analytes within these samples is examined. Results: The area of DBS samples decreases with increasing hematocrit levels in a linear manner on