2,726 results match your criteria Bioanalysis [Journal]


Toward comparability of anti-drug antibody assays: is the amount of anti-drug antibody-reagent complexes at cut-point (CP-ARC) the missing piece?

Bioanalysis 2020 Jul 7. Epub 2020 Jul 7.

Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Bioanalytical R&D, Roche Innovation Center Munich, Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany.

Immunogenicity testing is a mandatory and critical activity during the development of therapeutic proteins. Multiple regulatory guidelines provide clear recommendations on appropriate immunogenicity testing strategies and required bioanalytical assay performances. Unfortunately, it is still generally accepted that a comparison of the immunogenicity of different compounds is not possible due to apparent performance differences of the used bioanalytical methods. Read More

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http://dx.doi.org/10.4155/bio-2020-0143DOI Listing

Novel LC-MS/MS method for the determination of selumetinib (AZD6244) in whole blood collected with volumetric absorptive microsampling.

Bioanalysis 2020 Jul 6. Epub 2020 Jul 6.

Clinical Pharmacology & Safety Sciences, AstraZeneca, Da Vinci Building, Melbourn Science Park, Melbourn, Hertfordshire, SG8 6HB, UK.

A method has been developed and validated for quantitation of selumetinib in human whole blood collected using a Mitra™ volumetric absorptive microsampling device. This device is patient-friendly, affording less-invasive sampling with broad applicability to clinical and diagnostic applications - specifically in pediatric populations. In this method, drug is extracted from the Mitra device via sonication in methanol: Ammonium hydroxide, then analyzed by LC-MS/MS. Read More

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http://dx.doi.org/10.4155/bio-2020-0062DOI Listing

Kidney transplant recipient's perceptions of blood testing through microsampling and venepuncture.

Bioanalysis 2020 Jul 6. Epub 2020 Jul 6.

School of Pharmacy, University of Queensland, Brisbane, QLD 4102, Australia.

A survey of kidney transplant recipients receiving two innovative microsampling methods, dried blood spot and volumetric absorptive microsampling using patient reported methodology. A total of 39 adult transplant patients underwent venepuncture and finger prick-based blood draws on two occasions. They completed a survey of blood test understanding, tolerability, preferences and the burden associated with venepuncture compared with microsampling. Read More

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http://dx.doi.org/10.4155/bio-2020-0057DOI Listing

The development of patient-centric sampling as an enabling technology for clinical trials.

Authors:
Kevin P Bateman

Bioanalysis 2020 Jul 6. Epub 2020 Jul 6.

Pharmacokinetics, Pharmacodynamics & Drug Metabolism, Merck & Co., Inc. West Point, PA 19486, USA.

Accessing patient samples using a whenever/wherever paradigm is needed to enable a better understanding of human biology and disease. The technology for convenient self-collection of blood samples by patients at home is quickly becoming available. The potential benefits of patient-centric sampling far outweigh the short-term challenges associated with implementation of this disruptive approach. Read More

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http://dx.doi.org/10.4155/bio-2020-0075DOI Listing

Capillary microsampling in clinical studies: opportunities and challenges in two case studies.

Bioanalysis 2020 Jul 6. Epub 2020 Jul 6.

Development Bioanalysis, Janssen Research & Development, A division of Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium.

Capillary microsampling of 15 μl whole blood from fingersticks or heelsticks was used to collect pharmacokinetic (PK) samples from pediatric subjects in two projects. In a mebendazole multisite study in Ethiopia and Rwanda in subjects between 1 and 16 years old, complete PK profiles (7 timepoints) could be obtained, although some of the fingerstick samples were contaminated by the dosing formulation. In a multisite study with a respiratory syncytial virus drug in children between 1 and 24 months old, sparse PK sampling was done (2 samples). Read More

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http://dx.doi.org/10.4155/bio-2020-0054DOI Listing

High ionic strength dissociation assay (HISDA) for high drug tolerant immunogenicity testing.

Bioanalysis 2020 Jun 30. Epub 2020 Jun 30.

Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Bioanalytical R&D, Roche Innovation Center Munich, Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany.

Antidrug antibody (ADA) assessment may be challenged in studies that involve the administration of high doses of biotherapeutics and/or with long half-lives. In such cases, ADA assays with optimized drug tolerance are desired. We evaluated the use of MgCl to develop high ionic strength dissociation assays in two investigational examples (bridging enzyme-linked immunosorbent ADA assays) to attain high drug tolerance while maintaining best possible structural integrity of ADAs. Read More

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http://dx.doi.org/10.4155/bio-2020-0138DOI Listing

Bioanalytical research and training in academia during the COVID-19 pandemic.

Bioanalysis 2020 Jun 26. Epub 2020 Jun 26.

Life Sciences Mass Spectrometry, Inorganic & Analytical Chemistry, University of Geneva, Geneva, Switzerland.

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http://dx.doi.org/10.4155/bio-2020-0152DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7319492PMC

Laboratory considerations amidst the coronavirus disease 2019 outbreak: the Spedali Civili in Brescia experience.

Bioanalysis 2020 Jun 23. Epub 2020 Jun 23.

Department of Economics & Management, University of Brescia, Brescia, Italy.

Coronavirus disease 2019 emergency has created an enormous stress on providers that have been transformed into coronavirus disease hospitals. This article presents the experience of the clinical laboratory of Spedali Civili in Brescia (a teaching hospital in Lombardy with over 1500 beds) in managing the crisis, and to offer practical considerations for laboratory testing for this cohort of patients. Our contribution is threefold: by comparing the demand for tests in two representative period before and within the crisis, we show the change in compositions of the analytes that other labs may expect; we present the new panels of tests that hospital staff can order with different advantage for wards and laboratory; and we show how to reorganize staff on the basis of changes mentioned above. Read More

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http://dx.doi.org/10.4155/bio-2020-0109DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7315825PMC

Mass spectrometry analysis of urinary methylmalonic acid to screen for metabolic vitamin B deficiency in older adults.

Bioanalysis 2020 May 19;12(10):693-705. Epub 2020 Jun 19.

Division of Medical Genetics, Department of Pediatrics, Centre de Recherche-CHUS, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke J1H 5N4, QC, Canada.

Vitamin B deficiency is characterized metabolically by increased serum and urine methylmalonic acid (MMA). Urinary MMA/creatinine ratio is suggested for screening for metabolic vitamin B deficiency in older populations. A UPLC-MS/MS method for the analysis of urinary MMA and creatinine was developed/validated. Read More

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http://dx.doi.org/10.4155/bio-2020-0106DOI Listing

Therapeutic drug monitoring of polymyxin B by LC-MS/MS in plasma and urine.

Bioanalysis 2020 Jun 19. Epub 2020 Jun 19.

Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai 200040, PR China.

A robust and rapid method for therapeutic drug monitoring (TDM) is urgently needed for polymyxin B, which is a last-line antibiotic for multidrug-resistant gram-negative bacteria infection. A 3-min run of LC-MS/MS method was established to determine the main components of polymyxin B (polymyxin B1 and B2) in human plasma or urine. Solid-phase extraction was employed to eliminate the matrix effect from complicated samples from patients. Read More

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http://dx.doi.org/10.4155/bio-2020-0051DOI Listing

Recommendations for singlet-based approach in ligand binding assays: an IQ Consortium perspective.

Bioanalysis 2020 Jun 19. Epub 2020 Jun 19.

Bristol-Myers Squibb Company, Princeton, NJ 08543, USA.

Historically, ligand-binding assays for pharmacokinetic samples employed duplicate rather than singlet-based analysis. Herein, the Translational and absorption, distribution, metabolism and excretion (ADME) Sciences Leadership Group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) presents a study aiming to determine the value of duplicate versus singlet-based testing. Based on analysis of data collected from eight organizations for 20 drug candidates representing seven molecular types and four analytical platforms, statistical comparisons of validation and in-study quality controls and study unknown samples demonstrated good agreement across duplicate sets. Read More

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http://dx.doi.org/10.4155/bio-2020-0094DOI Listing

Gene doping and genomic science in sports: where are we?

Bioanalysis 2020 Jun 19;12(11):801-811. Epub 2020 Jun 19.

Laboratório de Biologia Molecular e Proteômica do Sangue (LABMOPS - LADETEC), Instituto de Química, Universidade Federal do Rio de Janeiro, UFRJ, Rio de Janeiro-RJ, Brasil.

The misuse of sport-related gene transfer methods in elite athletes is a real and growing concern. The success of gene therapy in the treatment of hereditary diseases has been most evident since targets in gene therapy products can be used in healthy individuals to improve sports performance. Performing these practices threatens the sporting character of competitions and may pose potential health hazards. Read More

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http://dx.doi.org/10.4155/bio-2020-0093DOI Listing

Innovation dynamics and globalization trends of high-throughput bioanalytical methods from a literature survey.

Bioanalysis 2020 Jun 19. Epub 2020 Jun 19.

Life Innovation Design Laboratory, Graduate School of Technology Management - MOT, Ritsumeikan University. 2-150, Iwakura-cho, Ibaraki-city, Osaka 5678570, Japan.

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http://dx.doi.org/10.4155/bio-2020-0100DOI Listing

Tranexamic acid quantification in human whole blood using liquid samples or volumetric absorptive microsampling devices.

Bioanalysis 2020 Jun 19. Epub 2020 Jun 19.

Département de Biotechnologie de la Santé, Université Paris-Saclay, UVSQ, INSERM, Infection et Inflammation, Montigny le Bretonneux, France.

Recent clinical trials demonstrate the benefits of the antifibrinolytic drug tranexamic acid but its pharmacokinetics remain to be investigated more in depth. Although pharmacokinetics studies are usually performed with plasma, volumetric absorptive microsampling devices allow us to analyze dried whole blood samples with several advantages. High-sensitivity LC-MS/MS methods for the quantification of tranexamic acid in human whole blood using liquid samples or dry samples on volumetric absorptive microsampling devices were developed and validated based on International Association from Therapeutic Drug Monitoring and Clinical Toxicology, European Medicines Agency and US Food and Drug Administration guidance. Read More

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http://dx.doi.org/10.4155/bio-2020-0088DOI Listing

Microsampling and LC-MS/MS for antidoping testing of glucocorticoids in urine.

Bioanalysis 2020 Jun 12;12(11):769-782. Epub 2020 Jun 12.

Research Group of Pharmaco-Toxicological Analysis (PTA Lab), Department of Pharmacy & Biotechnology (FaBiT), Alma Mater Studiorum -University of Bologna, Via Belmeloro 6, Bologna 40126, Italy.

Systemic glucocorticoids are prohibited in-competition by the World Anti-Doping Agency. Here, we describe an original microsampling workflow for the quantitation of three endogenous (cortisol, corticosterone and cortisone) and three exogenous (dexamethasone, methylprednisolone and fludrocortisone) corticosteroids in 30 μl of human urine. Microsampling was carried out by dried urine spot (DUS) sampling and volumetric absorptive microsampling (VAMS), followed by solvent extraction and LC-MS/MS analysis. Read More

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http://dx.doi.org/10.4155/bio-2020-0044DOI Listing

Virtual drug testing: redefining sample collection in a global pandemic.

Bioanalysis 2020 Jun 12;12(11):715-718. Epub 2020 Jun 12.

United States Anti-Doping Agency (USADA), Colorado Springs, CO 80919-9918, USA.

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http://dx.doi.org/10.4155/bio-2020-0119DOI Listing

Metabolomics and doping analysis: promises and pitfalls.

Bioanalysis 2020 Jun 12;12(11):719-722. Epub 2020 Jun 12.

Biomedical Research Center (BRC), Qatar University, Doha, Qatar.

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http://dx.doi.org/10.4155/bio-2020-0137DOI Listing

Erratum.

Authors:

Bioanalysis 2020 05;12(9):641

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http://dx.doi.org/10.4155/bio-2019-0267e1DOI Listing

Bioanalysis: waiting for Napoleon?

Authors:
Anthony B Jones

Bioanalysis 2020 May 5;12(10):649-653. Epub 2020 Jun 5.

Syneos Health, 301D College Road East, Princeton, NJ 08540, USA.

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http://dx.doi.org/10.4155/bio-2020-0135DOI Listing

Introducing automation to a regulated laboratory - an experience report.

Authors:
Michael Gröschl

Bioanalysis 2020 May 5;12(10):643-647. Epub 2020 Jun 5.

Celerion Switzerland AG, Allmendstrasse 32, Fehraltorf 8320, Switzerland.

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http://dx.doi.org/10.4155/bio-2020-0118DOI Listing

Extending flow cytometry sample stability by freezing lysed whole blood for clinical monitoring of Treg.

Bioanalysis 2020 May 3;12(10):655-663. Epub 2020 Jun 3.

PRA Health Sciences, 10836 Strang Line Road, Lenexa, KS 66215, USA.

A major challenge for flow cytometry assays supporting clinical trials is postcollection sample stability. Here we present an approach that could mitigate the stability issue while preserving sample integrity and cellular markers, especially when enumerating rare populations such as Tregs. Stability was evaluated using whole blood stored at room temperature and lysed whole blood stored at -80°C. Read More

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http://dx.doi.org/10.4155/bio-2020-0080DOI Listing
May 2020
3.003 Impact Factor

A validated LC-MS/MS method for the low-level determination of pemafibrate, a novel SPPARMα, in plasma.

Bioanalysis 2020 May 3;12(10):683-692. Epub 2020 Jun 3.

Department of Pharmacokinetics, Kyoto Pharmaceutical University, Kyoto 607 8414, Japan.

Pemafibrate, a novel selective peroxisome proliferator-activated receptor-α modulator, is prescribed for patients with dyslipidemia. To investigate other potential nonlipid-related effects of pemafibrate, the sensitive and rapid quantitation method for pemafibrate was required. The developed LC-MS/MS assay method exhibited excellent accuracy, precision, sensitivity, stability, no matrix effect and high recovery. Read More

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http://dx.doi.org/10.4155/bio-2020-0081DOI Listing

Fluispotter, a novel automated and wearable device for accurate volume serial dried blood spot sampling.

Bioanalysis 2020 May 3;12(10):665-681. Epub 2020 Jun 3.

Department of Clinical Biochemistry, KB3011, Rigshospitalet, Copenhagen, Denmark.

A novel automated serial dried blood spot (DBS) sampler, 'Fluispotter', was tested for its sampling performance. An LC-MS/MS method was developed for the analysis of cortisol in DBS samples serially spotted by Fluispotter. The cortisol concentrations in 148 paired DBS and plasma samples were compared across a hematocrit (HCT) range of 22-55%. Read More

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http://dx.doi.org/10.4155/bio-2020-0048DOI Listing

Development and validation of an UHPLC-MS/MS method for extended serum steroid profiling in female populations.

Bioanalysis 2020 Jun 1;12(11):753-768. Epub 2020 Jun 1.

Swiss Laboratory for Doping Analyses, University Center of Legal Medicine, Lausanne & Geneva, Lausanne University Hospital & University of Lausanne, Switzerland.

Quantitative endogenous steroid profiling in blood appears as a complementary approach to the urinary module of the World Anti-Doping Agency's Athlete Biological Passport Steroidal Module for the detection of testosterone doping. To refine this approach further, a UHPLC-MS/MS method was developed for the simultaneous determination of 14 free and 14 conjugated steroids in serum. The method was validated for quantitative purposes with satisfactory results in terms of selectivity, linearity range, trueness, precision and combined uncertainty (<20%). Read More

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http://dx.doi.org/10.4155/bio-2020-0046DOI Listing

Use of capillary dried blood for quantification of intact IGF-I by LC-HRMS for antidoping analysis.

Bioanalysis 2020 Jun 1;12(11):737-752. Epub 2020 Jun 1.

AFLD - Agence Française de Lutte contre le Dopage, Département des analyses, Châtenay-Malabry, France.

 IGF-I is used as a biomarker to detect Growth Hormone doping in athletes' blood samples. Our aim was to develop and validate a fast, high-throughput and accurate quantification of intact IGF-I from volumetric absorptive microsampling (VAMS) dried blood using LC coupled to high resolution mass spectrometry (LC-HRMS). IGF-I was extracted from the VAMS, released from its binding proteins, concentrated using microelution SPE and analyzed by LC-HRMS. Read More

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http://dx.doi.org/10.4155/bio-2020-0013DOI Listing

Biomarkers of doping: uses, discovery and validation.

Bioanalysis 2020 Jun 1;12(11):791-800. Epub 2020 Jun 1.

World Anti-Doping Agency, 800 Rue du Square-Victoria Suite 1700, Montreal, QC H4Z 1B7, Canada.

A biomarker of doping indicates the biological response to the use of a prohibited substance or method. Uncovering novel biomarkers of doping is a key objective in order to improve antidoping outcomes such as the detection of doping and changing athlete behavior toward doping practices. While the antidoping field has been successful in validating novel metabolites of prohibited substances, there has been less success in developing new biomarkers of doping. Read More

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http://dx.doi.org/10.4155/bio-2020-0035DOI Listing

A UHPLC-MS/MS method to determine FLZ major active metabolites in human plasma: application to a pharmacokinetic study.

Bioanalysis 2020 May 29;12(9):583-596. Epub 2020 May 29.

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical PK & PD Investigation for Innovative Drugs, No. 41 Damucang Hutong, Xicheng District, Beijing 100032, PR China.

FLZ, a novel promising dopamine neuroprotective agent, is designed to treat Parkinson's disease. F7G and F21G are FLZ major active Phase II metabolites whose exposure are nearly 100-times higher than FLZ, may chiefly produce effectiveness in human. Measurement of F7G and F21G in plasma samples is critical for investigating its pharmacokinetics in clinical studies. Read More

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http://dx.doi.org/10.4155/bio-2020-0033DOI Listing

Simultaneous determination of canrenone, digoxin and tolvaptan by UHPLC-MS/MS: application in heart failure patients.

Bioanalysis 2020 May 29;12(9):569-582. Epub 2020 May 29.

Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou City, Guangdong Province 510006, PR China.

Heart failure patients are frequently given comedication of digoxin and diuretics like spironolactone and tolvaptan. A UHPLC-MS/MS assay for determining canrenone (main active metabolite of spironolactone), digoxin and tolvaptan simultaneously should be developed so as to support related drug-drug interaction studies. A UHPLC-MS/MS method for simultaneous determination of these three drugs in human plasma was established and fully verified as per CFDA guidelines. Read More

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http://dx.doi.org/10.4155/bio-2020-0037DOI Listing

Rapid and robust bioanalytical assays are critical for SARS-CoV-2 therapeutic and vaccine development and beyond.

Bioanalysis 2020 May 26. Epub 2020 May 26.

Bioanalytical Sciences, Celerion Inc. 621 Rose St, Lincoln, NE 68502, USA.

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http://dx.doi.org/10.4155/bio-2020-0116DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7255425PMC

Ecofriendly chromatographic methods for determination of co-prescribed drugs, olanzapine and metformin, in rat plasma.

Bioanalysis 2020 May 22;12(9):597-613. Epub 2020 May 22.

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmed Hegazy St. Beni-Suef 62514, Beni-Suef, Egypt.

Olanzapine (OLZ) is one of most recommended drugs for the treatment of schizophrenia while metformin (MET) is the most commonly used hypoglycemic agent. Development and validation of two green, sensitive and accurate chromatographic methods for the simultaneous determination of OLZ along with the co-prescribed, MET. TLC-densitometric method with a developing system consisting of methylene chloride:methanol:ethyl acetate:triethylamine (4:4:5:0. Read More

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http://dx.doi.org/10.4155/bio-2020-0009DOI Listing

Enantiomeric analysis of clenbuterol in Chinese people by LC-MS/MS to distinguish doping abuse from meat contamination.

Bioanalysis 2020 Jun 22;12(11):783-790. Epub 2020 May 22.

Drug & Food Anti-Doping laboratory, China Anti-Doping Agency, 1st Anding Road, Chaoyang District, Beijing 100029, PR China.

Follow-up investigations are often required for clenbuterol-positive cases. A method to distinguish doping abuse from meat contamination was developed. A total of 26 volunteers were recruited to ingest clenbuterol contaminated-pork and clenbuterol tablets. Read More

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http://dx.doi.org/10.4155/bio-2020-0003DOI Listing

Challenges and recommendations in developing LC-MS/MS bioanalytical assays of labile glucuronides and parent compounds in the presence of glucuronide metabolites.

Bioanalysis 2020 May 22;12(9):615-624. Epub 2020 May 22.

Nonclinical Disposition & Bioanalysis, Bristol-Myers Squibb Co., Princeton, NJ 08543, USA.

Glucuronides, especially acyl glucuronides, were often found to be unstable and Acyl glucuronide metabolites can convert back to the parent drugs at physiological pH through hydrolysis. Glucuronides can also undergo in-source fragmentation during MS ionization to form the same ions as those of the parent compounds, which could cause interference to the analysis of the parent compounds. All of these may cause significant challenges in developing LC-MS/MS bioanalytical assays of labile glucuronides or parent compounds in the presence of glucuronide metabolites. Read More

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http://dx.doi.org/10.4155/bio-2020-0055DOI Listing

Chromatographic separation technologies: an overview of the Bioanalysis Zone survey.

Authors:
Alex Hyde

Bioanalysis 2020 Apr;12(8):505-508

Future Science Group, Unitec House, 2 Albert Place, London N3 1QB, UK.

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http://dx.doi.org/10.4155/bio-2020-0111DOI Listing

Automation of RNA-based biomarker extraction from dried blood spots for the detection of blood doping.

Bioanalysis 2020 Jun 15;12(11):729-736. Epub 2020 May 15.

Swiss Laboratory for Doping Analyses, University Center of Legal Medicine, Lausanne & Geneva, Lausanne University Hospital & University of Lausanne, Switzerland.

Transcriptomic biomarkers originating from reticulocytes measured in dried blood spots (DBSs) may be reliable indicators of blood doping. Here, we examined changes in the expression levels of the erythropoiesis-related ,  and  genes in DBS samples from elite athletes and volunteers of clinical study with recombinant erythropoietin dose. By comparing the mean intraday coefficients of variation for , ,  and between manual and automated RNA extractions, an average improvement was observed, whereas the assessment of interday variability provided comparable results for both manual and automated approaches. Read More

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http://dx.doi.org/10.4155/bio-2020-0041DOI Listing

Quantification of fat-soluble vitamins and their metabolites in biological matrices: an updated review.

Bioanalysis 2020 May 15;12(9):625-640. Epub 2020 May 15.

Clinical Pharmacology Laboratory, Department of Pharmacy Practice & Science, University of Nebraska Medical Center, Omaha, NE 68198, USA.

Fat-soluble vitamins (FSVs) are micronutrients essential in maintaining normal physiological function, metabolism and human growth. Ongoing increased awareness regarding FSV concentrations and their impact on human growth along with disease progression warrant the need of developing selective and sensitive analytical methods. LC-MS/MS is currently the method of choice for accurate quantitation of FSVs. Read More

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http://dx.doi.org/10.4155/bio-2020-0069DOI Listing
May 2020
3.003 Impact Factor

Metabolism of steroids and sport drug testing.

Bioanalysis 2020 May 15;12(9):561-563. Epub 2020 May 15.

Doping Control Laboratory, Seibersdorf Labor GmbH, Seibersdorf, Austria.

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http://dx.doi.org/10.4155/bio-2020-0077DOI Listing

Bioanalytical methods for quantification of novel sodium-glucose cotransporter 2 inhibitors: toward greener approach in separation science.

Bioanalysis 2020 May 15;12(9):565-568. Epub 2020 May 15.

Bioanalytical Research Department, Veeda Clinical Research, Ahmedabad 380009, Gujarat, India.

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http://dx.doi.org/10.4155/bio-2020-0103DOI Listing

Sensitive UHPLC-MS/MS method for the determination of tacrolimus in minipig whole blood.

Bioanalysis 2020 Apr 30;12(8):519-532. Epub 2020 Apr 30.

Department of DMPK Development, Almirall, S.A., Laureà Miró 408-410, 08980 Sant Feliu de Llobregat, Barcelona, Spain.

Tacrolimus, a potent immunosuppressant drug widely used systemically to reduce the risk of organ rejection in transplants, has been repositioned for topical treatment of atopic dermatitis. This work describes the optimization of a new method for the determination of tacrolimus in whole blood after topical administration. Sample treatment consisted of an automated procedure based on protein precipitation followed by solid-phase extraction. Read More

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http://dx.doi.org/10.4155/bio-2020-0039DOI Listing

Evaluation, identification and impact assessment of abnormal internal standard response variability in regulated LC-MS bioanalysis.

Bioanalysis 2020 Apr 30;12(8):545-559. Epub 2020 Apr 30.

Pharmacokinetic Sciences, Novartis Institutes for BioMedical Research, East Hanover, NJ 07936, USA.

Internal standard (IS) plays an important role in LC-MS bioanalysis by compensating for the variability of the analyte of interest in bioanalytical workflow. Due to the complexity of biological sample compositions and bioanalytical processes, a certain level of IS response variability across a run or a study is anticipated. However, an extensive variability may raise doubts to the accuracy of the measured results and also suggest nonoptimal analytical method. Read More

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http://dx.doi.org/10.4155/bio-2020-0058DOI Listing

Metabolic profiling in the arena of gut-brain interaction studies for Alzheimer's disease.

Bioanalysis 2020 Apr 30;12(8):501-504. Epub 2020 Apr 30.

Laboratory of Forensic Medicine & Toxicology, Department of Medicine, Aristotle University of Thessaloniki, Thessaloniki 54124, Greece.

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http://dx.doi.org/10.4155/bio-2020-0066DOI Listing

Novel bioanalytical method for the characterization of the immune response directed against a bispecific F(ab) fragment.

Bioanalysis 2020 Apr 30;12(8):509-517. Epub 2020 Apr 30.

Roche Pharma Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Im Nonnenwald 2, 82377 Penzberg, Germany.

The work was aimed at developing a bioanalytical approach to identify immunogenic parts of a bispecific F(ab) fragment and to characterize the immune response seen in a preclinical study. The bioanalytical method consists of a set of domain detection assays that use germlined variants of the drug. The method demonstrated that anti-drug antibodies (ADAs) were predominantly directed against both antigen-binding sites of the drug. Read More

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http://dx.doi.org/10.4155/bio-2020-0064DOI Listing

LC-MS/MS method for the quantification of SUVN-G3031, a novel H3 receptor inverse agonist for narcolepsy treatment.

Bioanalysis 2020 Apr 30;12(8):533-544. Epub 2020 Apr 30.

Biopharmaceutical Research, Suven Life Sciences Ltd, Serene Chambers, Road-5, Avenue-7, Banjara Hills, Hyderabad 500 034, India.

A LC-MS/MS method was validated for the quantification of SUVN-G3031, a novel H3 receptor inverse agonist in clinical development for the treatment of patients with narcolepsy, with and without cataplexy. SUVN-G3031 was extracted from plasma following acetonitrile protein precipitation, separated by Ultra HPLC and quantified using positive ESI-MS/MS. The method was linear across the range of 0. Read More

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http://dx.doi.org/10.4155/bio-2020-0020DOI Listing

Flow-based method for the determination of biomarkers urea and ammoniacal nitrogen in saliva.

Bioanalysis 2020 Apr 28;12(7):455-465. Epub 2020 Apr 28.

Universidade Católica Portuguesa, CBQF - Centro de Biotecnologia e Química Fina - Laboratório Associado, Escola Superior de Biotecnologia, Rua Diogo Botelho 1327, 4169 -005 Porto, Portugal.

Salivary urea and ammonium levels are potential biomarkers for chronic kidney disease. A fast and efficient assessment of these compounds in the saliva of healthy and diseased individuals may be a useful tool to monitor kidney function. Ammonium ions were measured with an ammonia selective electrode after conversion to ammonia gas. Read More

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http://dx.doi.org/10.4155/bio-2020-0036DOI Listing

Strategies for effective development of ultra-sensitive LC-MS/MS assays: application to a novel STING agonist.

Bioanalysis 2020 Apr 28;12(7):467-484. Epub 2020 Apr 28.

Bioanalysis, Immunogenicity & Biomarkers, IVIVT, GlaxoSmithKline Pharmaceuticals, 1250 S. Collegeville Rd, Collegeville, PA 19426, USA.

The continual need for the development and validation of ultra-sensitive (low pg/ml) LC-MS/MS assays in the pharmaceutical industry is largely driven by the ultra-low analyte exposure or very low sample volume. Strategies and systematic approaches for sensitivity enhancement are provided which cover all aspects of a LC-MS/MS bioanalysis. A case study where such strategies were applied for the validation of a 5. Read More

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http://dx.doi.org/10.4155/bio-2020-0038DOI Listing

Visualizing bioanalytical methods - a near or distant future?

Bioanalysis 2020 Apr 28;12(7):427-429. Epub 2020 Apr 28.

Łukasiewicz Research Network - Pharmaceutical Research Institute, Pharmacokinetics Department, 8 Rydygiera Street, 01-793 Warsaw, Poland.

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http://dx.doi.org/10.4155/bio-2020-0060DOI Listing

The analysis of acetaminophen (paracetamol) and seven metabolites in rat, pig and human plasma by U(H)PLC-MS.

Bioanalysis 2020 Apr 28;12(7):485-500. Epub 2020 Apr 28.

Division of Systems Medicine, Department of Metabolism, Digestion & Reproduction, Imperial College London, Exhibition Road, South Kensington, London SW7 2AZ, UK.

A U(H)PLC-MS/MS method is described for the analysis of acetaminophen and its sulphate, glucuronide, glutathione, cysteinyl and N-acetylcysteinyl metabolites in plasma using stable isotope-labeled internal standards. -Aminophenol glucuronide and 3-methoxyacetaminophen were monitored and semi-quantified using external standards. The assay takes 7. Read More

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http://dx.doi.org/10.4155/bio-2020-0015DOI Listing

A robust LC-MS/MS method for amikacin: application to cellular uptake and pharmacokinetic studies.

Bioanalysis 2020 Apr 28;12(7):445-454. Epub 2020 Apr 28.

Department of Pharmacological & Pharmaceutical Sciences, University of Houston College of Pharmacy, 4849 Calhoun Road, Houston, TX 77204, USA.

Aminoglycosides are last-resort antibiotics for bacterial infections due to concerns of nephrotoxicity. A robust method is needed to correlate the magnitude of drug accumulation in the kidneys and the onset of nephrotoxicity.  A LC-MS/MS assay was developed, circumventing common limitations associated with conventional assays. Read More

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http://dx.doi.org/10.4155/bio-2020-0007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7270885PMC

Strategies for method comparison when changes in the immunogenicity method are needed within a clinical program.

Bioanalysis 2020 Apr 28;12(7):431-443. Epub 2020 Apr 28.

Immunochemistry Department, PPD Laboratories, Richmond, VA, USA.

To present the reader with different approaches used to compare immunogenicity methods when changes are needed during a clinical program. Five case studies are presented, in the first two case studies, the approach utilized a small sample size for the comparison. In the third case, all samples from a study were analyzed by both methods. Read More

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http://dx.doi.org/10.4155/bio-2019-0300DOI Listing

Validation and clinical application of dried blood spot assay for quantitative assessment of edoxaban in healthy adults.

Bioanalysis 2020 Mar;12(6):393-407

Daiichi Sankyo, Inc., 211 Mt. Airy Road, Basking Ridge, NJ 07920, USA.

Dried blood spot (DBS) is a sampling approach that offers several advantages over plasma and whole blood (WB) sampling, but several factors, such as hematocrit and temperature, can adversely affect quantitation. In an open-label, three-way crossover study in healthy subjects, we explored the correlation between DBS, WB and plasma samples, and between DBS samples from finger-prick and venipuncture blood for measuring edoxaban and its metabolite M-4 using LC-MS/MS. The methods were validated comprehensively. Read More

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http://dx.doi.org/10.4155/bio-2019-0180DOI Listing