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Bioanalysis

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https://www.readbyqxmd.com/read/28434245/simultaneous-quantitation-of-the-bace1-inhibitor-azd3293-and-its-metabolite-az13569724-in-human-matrices-by-lc-ms-ms
#1
Yan Li, Paul H Severin, Mark R Hoffmann, Dennis L Miller, Scott A Monk, Alan R Kugler
AIM: AZD3293 is a novel BACE1 inhibitor in Phase III development for Alzheimer's disease. Sensitive and robust bioanalytical methods were required to quantitate AZD3293 and its metabolite AZ13569724 in human biological matrices. METHODOLOGY/RESULTS: Human plasma was prepared by protein precipitation. Linearity for both analytes was in the range of 0.5-500 ng/ml with up to 100-fold dilution. Plasma ultrafiltrate samples were prepared using Centrifree(®) ultrafiltration device...
April 24, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28355126/plasma-protein-binding-monitoring-of-therapeutic-drugs-in-patients-using-single-set-of-hollow-fiber-centrifugal-ultrafiltration
#2
Xinyu Wang, Cen Li, Chaohui Du, Jing-Lin Gao, Ke-Xin Zhao, Rui Shi, Ye Jiang
AIM: Plasma protein binding (PPB), as a significant influenced factor of pharmacokinetic and pharmacodynamic properties of a medicine, is a suitable index for therapeutic drug monitoring (TDM) strategies. A suitable measurement technique of PPB of patients is in urgent need and attracts many analysts' attention. Results & methodology: In this study, a novel method was proposed to analyze free drug concentration and total drug concentration (Ct) successively in one unit with a sample. All RSDs were less than 3%...
March 29, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28339299/the-10th-gcc-closed-forum-rejected-data-gcp-in-bioanalysis-extract-stability-bav-processed-batch-acceptance-matrix-stability-critical-reagents-eln-and-data-integrity-and-counteracting-fraud
#3
Stephanie Cape, Rafiq Islam, Corey Nehls, John Allinson, Afshin Safavi, Patrick Bennett, James Hulse, Chris Beaver, Masood Khan, Shane Karnik, Maria Cruz Caturla, Steve Lowes, Adriana Iordachescu, Luigi Silvestro, Rabab Tayyem, Ron Shoup, Stephanie Mowery, Anahita Keyhani, Andrea Wakefield, Yinghe Li, Jennifer Zimmer, Javier Torres, Philippe Couerbe, Ardeshir Khadang, James Bourdage, Nicola Hughes, Kayode Awaiye, Brent Matthews, Saadya Fatmi, Rhonda Johnson, Christina Satterwhite, Mathilde Yu, Jenny Lin, Laura Cojocaru, Michele Fiscella, Eric Thomas, Kai Kurylak, John Kamerud, Zhongping John Lin, Wei Garofolo, Natasha Savoie, Mike Buonarati, Nadine Boudreau, Clark Williard, Yansheng Liu, Dominic Warrino, Prashant Kale, Neil Adcock, Radha Shekar, Edward O'Connor, Hanna Ritzen, Christina Sanchez, Roger Hayes, Mohammed Bouhajib, Simona Rizea Savu, Bruce Stouffer, Edward Tabler, Jing Tu, Chad Briscoe, Barry van der Strate, Paul Rhyne, Phyllis Conliffe, Ira DuBey, Jim Yamashita, Daniel Tang, Elizabeth Groeber, Jenifer Vija, Michele Malone, Mohamed Osman
The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud...
March 24, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28339283/development-optimization-and-implementation-of-a-centralized-metabolic-soft-spot-assay
#4
Anthony A Paiva, Cheryl Klakouski, Shu Li, Benjamin M Johnson, Yue-Zhong Shu, Jonathan Josephs, Tatyana Zvyaga, Ismael Zamora, Wilson Z Shou
AIM: High clearance is a commonly encountered issue in drug discovery. Here we present a centralized metabolic soft spot identification assay with adequate capacity and turnaround time to support the metabolic optimization needs of an entire discovery organization. METHODOLOGY: An integrated quan/qual approach utilizing both an orthogonal sample-pooling methodology and software-assisted structure elucidation was developed to enable the assay. Major metabolic soft spots in liver microsomes (rodent and human) were generated in a batch mode, along with kinetics of parent disappearance and metabolite formation, typically within 1 week of incubation...
March 24, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28300424/the-application-of-capillary-microsampling-in-glp-toxicology-studies
#5
Tom Verhaeghe, Lieve Dillen, Hans Stieltjes, Loeckie de Zwart, Bianca Feyen, Luc Diels, Ann Vroman, Philip Timmerman
AIM: Capillary microsampling (CMS) to collect microplasma volumes is gradually replacing traditional, larger volume sampling from rats in GLP toxicology studies. METHODOLOGY: About 32 µl of blood is collected with a capillary, processed to plasma and stored in a 10- or 4-µl capillary which is washed out further downstream in the laboratory. CMS has been standardized with respect to materials, assay validation experiments and application for sample analysis. CONCLUSION: The implementation of CMS has resulted in blood volume reductions in the rat from 300 to 32 µl per timepoint and the elimination of toxicokinetic satellite groups in the majority of the rat GLP toxicology studies...
March 16, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28300423/ensuring-quality-and-compliance-in-outsourcing-of-bioanalysis-of-clinical-biomarkers
#6
Tianke Wang, Arkady I Gusev
No abstract text is available yet for this article.
March 16, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28300420/a-new-lc-ms-ms-bioanalytical-method-for-atenolol-in-human-plasma-and-milk
#7
Ei Mon Phyo Lwin, Cobus Gerber, Yunmei Song, Catherine Leggett, Usha Ritchie, Sean Turner, Sanjay Garg
AIM: A new sensitive LC-MS/MS method for the quantification of atenolol in human plasma and milk has been developed for clinical lactation studies. METHODS & RESULTS: Atenolol and the internal standard, phenazone, were extracted from biological matrices by protein precipitation. A Phenomenex(®) C-18 column and gradient chromatographic conditions were used for separation of the analyte, followed by detection with MS. Stability of samples was confirmed for atenolol in human plasma and milk for up to 3 months...
March 16, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28300419/dried-blood-spot-validation-of-five-immunosuppressants-without-hematocrit-correction-on-two-lc-ms-ms-systems
#8
Remco A Koster, Herman Veenhof, Rixt Botma, Alle Tjipke Hoekstra, Stefan P Berger, Stephan Jl Bakker, Jan-Willem C Alffenaar, Daan J Touw
AIM: Hematocrit (Ht) effects remain a challenge in dried blood spot (DBS) sampling. The aim was to develop an immunosuppressant DBS assay on two LC-MS/MS systems covering a clinically relevant Ht range without Ht correction. RESULTS: The method was partially validated for tacrolimus, sirolimus, everolimus, cyclosporin A and fully validated for mycophenolic acid on an Agilent and Thermo LC-MS/MS system. Bias caused by Ht effects were within 15% for all immunosuppressants between Ht levels of 0...
March 16, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28300418/incurred-sample-reanalysis-of-fingolimod-and-fingolimod-phosphate-in-blood-stability-evaluation-and-application-to-a-rat-pharmacokinetic-study
#9
Ramakrishna Nirogi, Nagasurya Prakash Padala, Devender Reddy Ajjala, Rajesh Kumar Boggavarapu, Praveen Kunduru
BACKGROUND: Incurred sample reanalysis (ISR) is an in-study validation parameter, which reinforces that the validated bioanalytical methods are reproducible. ISR of whole blood samples is complex when the test compounds can interconvert, ex vivo. Fingolimod and fingolimod phosphate are highly distributed in the blood cellular components and undergo rapid interconversion, both in vivo and ex vivo. An LC-MS/MS method capable of simultaneous quantification of fingolimod and fingolimod phosphate with the controlled sample preparation procedure is essential...
March 16, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28290705/erratum
#10
(no author information available yet)
No abstract text is available yet for this article.
March 14, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28207284/characterization-and-qc-of-biopharmaceuticals-by-ms-based-multi-attribute-method-advantages-and-challenges
#11
Yun Zhang, Jingzhong Guo
No abstract text is available yet for this article.
February 16, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28229619/measurement-of-hepcidin-isoforms-in-human-serum-by-liquid-chromatography-with-high-resolution-mass-spectrometry
#12
Simon Handley, Lewis Couchman, Paul Sharp, Iain Macdougall, Cajetan Moniz
AIM: Hepcidin-25 is the master regulator of iron homeostasis. N-truncated isoforms of hepcidin-25 have been identified (hepcidin-20, -22, -24), although data on the concentrations of these isoforms are sparse. MATERIALS & METHODS: Serum was mixed with aqueous formic acid, and the supernatant loaded onto a 96-well-SPE-plate. Eluted analytes were analyzed using LC-HR-MS. Forty-seven paired dipotassium-EDTA human plasma and serum samples were analyzed. RESULTS: The LLOQ was 1 μg/l (all analytes)...
March 2017: Bioanalysis
https://www.readbyqxmd.com/read/28225304/column-switching-uhplc-ms-ms-with-restricted-access-material-for-the-determination-of-cns-drugs-in-plasma-samples
#13
Vinicius Ricardo Acquaro, Diego Soares Domingues, Maria Eugênia Costa Queiroz
BACKGROUND: Polypharmacy is a common practice in schizophrenia. Consequently, therapeutic drug monitoring is usually adopted to maintain the concentrations of the drugs in the plasma within a targeted therapeutic range, to maximize therapeutic efficiency and to diminish adverse side effects. METHODOLOGY: This study reports on a column switching UHPLC-MS/MS method to determine psychotropic drugs in plasma samples simultaneously. RESULTS: The method was linear from 0...
March 2017: Bioanalysis
https://www.readbyqxmd.com/read/28225302/rapid-immunoassay-exploiting-nanoparticles-and-micromagnets-proof-of-concept-using-ovalbumin-model
#14
Sarah Delshadi, Guillaume Blaire, Paul Kauffmann, Mario Fratzl, Thibaut Devillers, Didier Delabouglise, Marianne Weidenhaupt, Nora M Dempsey, Orphée Cugat, Franz Bruckert, Patrice N Marche
AIM: We present a fast magnetic immunoassay, combining magnetic nanoparticles and micromagnets. High magnetic field gradients from micromagnets are used to develop a new approach to the standard ELISA. Materials & methods/results: A proof-of-concept based on colorimetric quantification of antiovalbumin antibody in buffer is performed and compared with an ELISA. After optimization, the magnetic immunoassay exhibits a limit of detection (40 ng/ml) and a dynamic range (40-2500 ng/ml) similar to that of ELISAs developed using same biochemical tools...
March 2017: Bioanalysis
https://www.readbyqxmd.com/read/28225297/development-of-an-uplc-ms-ms-micromethod-for-quantitation-of-cinitapride-in-plasma-and-its-application-in-a-pharmacokinetic-interaction-trial
#15
RANDOMIZED CONTROLLED TRIAL
Gabriel Marcelín-Jiménez, Leticia Contreras, Javier Esquivel, Óscar Ávila, Dany Batista, Alionka P Ángeles, Alberto García-González
AIM: Cinitapride (CIN) is a benzamide-derived molecule used for the treatment of gastroesophageal reflux and dyspepsia. Its pharmacokinetics are controversial due to the use of supratherapeutic doses and the lack of sensitive methodology. Therefore, a sensitive and accurate micromethod was developed for its quantitation in human plasma. RESULTS: CIN was extracted from 300 µl of heparinized plasma by liquid-liquid extraction using cisapride as internal standard, and analyzed with an ultra performance liquid chromatograph employing positive multiple-reaction monitoring-MS...
March 2017: Bioanalysis
https://www.readbyqxmd.com/read/28225296/development-and-validation-of-an-lc-ms-ms-method-for-simultaneously-determining-doxapram-and-keto-doxapram-in-human-serum
#16
Yuki Suzuki, Noboru Kamada, Hitoshi Ohno, Yoshikazu Abe, Takuro Endo, Mamoru Kobayashi
AIM: Doxapram, a respiratory stimulant, is used to treat apnea. A reliable method of determining doxapram in blood is required for monitoring purposes. RESULTS: Doxapram, keto-doxapram (active metabolite) and propranolol (internal standard) were extracted from human serum by protein precipitation and plate filtration. Molecular ions were generated by electrospray ionization in positive ion mode, and the ions were analyzed using a triple-quadrupole mass spectrometer...
March 2017: Bioanalysis
https://www.readbyqxmd.com/read/28220712/a-novel-quantitative-method-for-recovering-precipitated-uric-acid-in-urine-and-analysis-by-lc-ms-ms
#17
Lifang Sun, Dongmei Zhou, David M Wilson
AIM: Precipitation of uric acid (UA) in human urine had caused poor recovery and underestimation of UA in study samples. RESULTS: A UA recovery method was developed for analyzing frozen urine samples that potentially contain precipitated UA. Samples were treated with 3% v/v of a solution containing 8 M potassium hydroxide and 20% v/v of ammonium thioglycolate. The high pH enables rapid dissolution of UA crystals, while the thioglycolate protects UA from oxidation at high pH...
March 2017: Bioanalysis
https://www.readbyqxmd.com/read/28220711/comparison-of-hba1c-detection-in-whole-blood-and-dried-blood-spots-using-an-automated-ion-exchange-hplc-system
#18
COMPARATIVE STUDY
Aleksandra Maleska, Christophe Hirtz, Elise Casteleyn, Orianne Villard, Jacques Ducos, Antoine Avignon, Ariane Sultan, Sylvain Lehmann
AIM: Hemoglobin A1c (HbA1c) is a widely recognized analyte for diagnosing and monitoring diabetes. Dried blood spot (DBS) constitutes a useful alternative to blood collection by venipuncture. Analytical and clinical validation of DBS use is, however, necessary before implementation. Results/methodology: HbA1c levels from whole blood or DBS from a cohort patients with diabetes were compared. DBS specimens were stable at ambient temperature. HbA1c detection on DBS was accurate, robust, and the correlation and agreement with whole blood values was excellent...
March 2017: Bioanalysis
https://www.readbyqxmd.com/read/28207286/lc-ms-ms-simultaneous-analysis-of-allopregnanolone-epiallopregnanolone-pregnanolone-dehydroepiandrosterone-and-dehydroepiandrosterone-3-sulfate-in-human-plasma
#19
Luana Lionetto, Fernando De Andrés, Matilde Capi, Martina Curto, Donata Sabato, Maurizio Simmaco, Paola Bossù, Eleonora Sacchinelli, Maria Donata Orfei, Federica Piras, Nerisa Banaj, Gianfranco Spalletta
AIM: Several neuropsychopharmacological properties have been attributed to the 3α-reduced pregnane steroids, allopregnanolone and pregnanolone, as well as to dehydroepiandrosterone sulfate because of their ability to modulate γ-aminobutyric acid (GABAA) receptors in the CNS. In order to understand better their role in several mechanisms in CNS, a new methodology is proposed to monitor these compounds in human plasma. Methodology & results: The analytes were first derivatized with 2-hydrazinopyridine and extracted from plasma using SPE...
March 2017: Bioanalysis
https://www.readbyqxmd.com/read/28176545/rapid-quantification-of-free-and-glucuronidated-thccooh-in-urine-using-coated-well-plates-and-lc-ms-ms-analysis
#20
Marianne Hädener, Wolfgang Weinmann, Dave R van Staveren, Stefan König
AIM: Generally, urine drug testing for cannabis abuse involves measuring total concentrations of 11-nor-9-carboxy-Δ(9)-tetrahydrocannabinol (THCCOOH) obtained by enzymatic and/or alkaline hydrolysis of THCCOOH-glucuronide. As hydrolysis can be inconsistent and incomplete, direct measurement of the two metabolites is preferable. Methodology & results: We developed a high-throughput LC-MS/MS method for simultaneous quantification of free and glucuronidated THCCOOH in urine using coated 96-well plates for analyte extraction and column-switching chromatography...
March 2017: Bioanalysis
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