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https://www.readbyqxmd.com/read/28646659/analysis-of-recombinant-monoclonal-antibodies-in-hydrophilic-interaction-chromatography-a-generic-method-development-approach
#1
Balázs Bobály, Valentina D'Atri, Alain Beck, Davy Guillarme, Szabolcs Fekete
Hydrophilic interaction liquid chromatography (HILIC) is a well-established technique for the separation and analysis of small polar compounds. A recently introduced widepore stationary phase expanded HILIC applications to larger molecules, such as therapeutic proteins. In this paper, we present some generic HILIC conditions adapted for a wide range of FDA and EMA approved recombinant monoclonal antibody (mAb) species and for an antibody-drug conjugate (ADC). Seven approved mAbs possessing various isoelectric point (pI) and hydrophobicity as well as a cysteine conjugated ADC were used in this study...
June 15, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28645518/blood-gas-analyzer-accuracy-of-glucose-measurements
#2
Yafen Liang, Jonathan Wanderer, James H Nichols, David Klonoff, Mark J Rice
OBJECTIVE: To investigate the comparability of glucose levels measured with blood gas analyzers (BGAs) and by central laboratories (CLs). MATERIAL AND METHODS: Glucose measurements obtained between June 1, 2007, and March 1, 2016, at the Vanderbilt University Medical Center were reviewed. The agreement between CL and BGA results were assessed using Bland-Altman, consensus error grid (CEG), and surveillance error grid (SEG) analyses. We further analyzed the BGAs' performance against the US Food and Drug Administration (FDA) 2014 draft guidance and 2016 final guidance for blood glucose monitoring and the International Organization for Standardization (ISO) 15197:2013 standard...
June 7, 2017: Mayo Clinic Proceedings
https://www.readbyqxmd.com/read/28644704/numerical-analysis-of-time-dependent-inhibition-kinetics-comparison-between-rat-liver-microsomes-and-rat-hepatocyte-data-for-mechanistic-model-fitting
#3
Chuong Pham, Swati Nagar, Ken Korzekwa
Time dependent inhibition (TDI) may confound drug interaction predictions. Recently, models were generated for an array of TDI kinetic schemes using numerical analysis of microsomal assays. Additionally, a distinct terminal inactivation step was identified for certain mechanism based inhibitors (MBI) following reversible metabolite intermediate complex (MIC) formation. Longer hepatocyte incubations potentially allow analysis of slow TDI and terminal inactivation. In the experiments presented here, we compared the quality of TDI parameterization by numerical analysis between hepatocyte and microsomal data...
June 23, 2017: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
https://www.readbyqxmd.com/read/28643030/hospital-electronic-prescribing-system-implementation-impact-on-discharge-information-communication-and-prescribing-errors-a-before-and-after-study
#4
Pamela Ruth Mills, Anita Elaine Weidmann, Derek Stewart
PURPOSE: The study aimed to test the hypothesis that hospital electronic prescribing and medicine administration system (HEPMA) implementation impacted patient discharge letter quality, nature and frequency of prescribing errors. METHOD: A quasi experimental before and after retrospective case note review was conducted in one United Kingdom district general hospital. The total sample size was 318 (random samples of 159 before and after implementation), calculated to achieve a 10% error reduction with a power of 80% and p < 0...
June 22, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28642027/-monitoring-devices-and-their-alarms-incident-reports-suggest-problems-with-device-knowledge
#5
Kathrin Lange, Miriam Nowak, Claudia Neudörfl, Wolfgang Lauer
Missing or false device alarms pose a risk in clinical practice. Publications from the United States suggest that alarm errors are not only caused by technical issues but to a considerable degree result from user-device interaction problems. To safely operate a medical device, users have to thoroughly understand both device behavior and device functioning. They also need to foresee the exact consequences of their interactions with the device. This can be challenging, especially if a device has multiple functions, is applied in various use contexts or networked with other devices - as is often the case with patient monitors...
June 19, 2017: Zeitschrift Für Evidenz, Fortbildung und Qualität Im Gesundheitswesen
https://www.readbyqxmd.com/read/28640946/physicians-non-uniform-approach-to-prescribing-drugs-to-older-patients-a-qualitative-study
#6
Line Due Christensen, Janne Petersen, Ove Andersen, Susanne Kaae
Multi-morbidity and polypharmacy are common in older patients and increase their susceptibility to adverse drug events and hospitalizations. Rational drug prescription is critical, however, little is known about physicians' perspectives on how to prescribe drugs for older patients. The aim of this study was to explore physicians' approach to prescribe drugs to older patients, including identifying the drugs that physicians perceive to be risk drugs for older patients and comparing them with established lists of potentially inappropriate medications...
June 22, 2017: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/28640025/performance-of-a-modern-glucose-meter-in-icu-and-general-hospital-inpatients-3-years-of-real-world-paired-meter-and-central-laboratory-results
#7
Ray Zhang, Warren Isakow, Marin H Kollef, Mitchell G Scott
OBJECTIVE: Due to accuracy concerns, the Food and Drug Administration issued guidances to manufacturers that resulted in Center for Medicare and Medicaid Services stating that the use of meters in critically ill patients is "off-label" and constitutes "high complexity" testing. This is causing significant workflow problems in ICUs nationally. We wished to determine whether real-world accuracy of modern glucose meters is worse in ICU patients compared with non-ICU inpatients. DESIGN: We reviewed glucose results over the preceding 3 years, comparing results from paired glucose meter and central laboratory tests performed within 60 minutes of each other in ICU versus non-ICU settings...
June 21, 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/28634583/circular-rnas-biogenesis-function-and-role-in-human-diseases
#8
REVIEW
John Greene, Anne-Marie Baird, Lauren Brady, Marvin Lim, Steven G Gray, Raymond McDermott, Stephen P Finn
Circular RNAs (circRNAs) are currently classed as non-coding RNA (ncRNA) that, unlike linear RNAs, form covalently closed continuous loops and act as gene regulators in mammals. They were originally thought to represent errors in splicing and considered to be of low abundance, however, there is now an increased appreciation of their important function in gene regulation. circRNAs are differentially generated by backsplicing of exons or from lariat introns. Unlike linear RNA, the 3' and 5' ends normally present in an RNA molecule have been joined together by covalent bonds leading to circularization...
2017: Frontiers in Molecular Biosciences
https://www.readbyqxmd.com/read/28634136/tongxie-formula-reduces-symptoms-of-irritable-bowel-syndrome
#9
Heng Fan, Liang Zheng, Yaoliang Lai, Weimin Lu, Zhixiang Yan, Qi Xiao, Baiwen Li, Min Tang, Dawei Huang, Yuanyuan Wang, Zhen Li, Yuwei Mei, Zhengyan Jiang, Xingxing Liu, Qing Tang, Dongmei Zuo, Jingyi Ye, Yongqiang Yang, Huisuo Huang, Zongxiang Tang, Jun Xiao
BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is the most common chronic gastrointestinal disorder, yet few drugs are effective in reducing symptoms. Approximately 50% of patients with IBS attempt herbal therapy at least once. We performed a randomized controlled trial to compare the efficacy of the herb formulation tongxie vs placebo or pinaverium (an antispasmodic agent) in reducing symptoms of IBS. METHODS: We performed a trial of 1044 adult patients with IBS (based on Rome III criteria) at 5 hospitals in China, from August 2012 through January 2015...
June 17, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28633695/how-should-discordance-between-molecular-and-growth-based-assays-for-rifampicin-resistance-be-investigated
#10
S Hofmann-Thiel, H Hoffmann, D Hillemann, L Rigouts, A Van Deun, K Kranzer
Molecular tests to detect the presence of Mycobacterium tuberculosis and genetic polymorphisms in the rpoB gene conferring resistance to rifampicin (RMP) have become integral parts of tuberculosis diagnostics worldwide. These assays are often performed sequentially or in parallel to phenotypic drug susceptibility testing. Discordances between molecular and phenotypic tests invariably occur. Root causes range from pre-, post- and analytic errors to co-existence of non-tuberculous mycobacteria, silent mutations, mutations outside the 81 base-pair RMP resistance-determining region, non-canonical mutations conferring increased minimal inhibitory concentrations below the critical concentration in some phenotypic drug susceptibility tests, and heteroresistance...
July 1, 2017: International Journal of Tuberculosis and Lung Disease
https://www.readbyqxmd.com/read/28630838/a-case-report-of-an-unusual-case-of-tuberculous-osteomyelitis-causing-spontaneous-pathological-fracture-of-humerus-in-a-middle-aged-female
#11
Umesh Birole, Ashish Ranade, Mahesh Mone
INTRODUCTION: Tuberculosis is a major health problem worldwide. Extrapulmonary tuberculosis is often secondary to some primary foci in lungs. There are reports of tuberculous osteomyelitis involving maxilla, ulna, femur, and shoulder joint but none have reported pathological fracture in humeral diaphysis due to tuberculosis osteomyelitis without shoulder joint involvement. We report a case of pathological fracture of humerus diaphysis due to tuberculous osteomyelitis with normal articular space...
January 2017: Journal of Orthopaedic Case Reports
https://www.readbyqxmd.com/read/28629581/impact-of-a-teamstepps-trauma-nurse-academy-at-a-level-1-trauma-center
#12
V Kristen Peters, Ellen M Harvey, Andi Wright, Jennifer Bath, Dan Freeman, Bryan Collier
PROBLEM: Nurses are crucial members of the team caring for the acutely injured trauma patient. Until recently, nurses and physicians gained an understanding of leadership and supportive roles separately. With the advent of a multidisciplinary team approach to trauma care, formal team training and simulation has transpired. METHODS: Since 2007, our Level I trauma system has integrated TeamSTEPPS (Team Strategies & Tools to Enhance Performance & Patient Safety; Agency for Healthcare Research and Quality, Rockville, MD) into our clinical care, joint training of nurses and physicians, using simulations with participation of all health care providers...
June 16, 2017: Journal of Emergency Nursing: JEN: Official Publication of the Emergency Department Nurses Association
https://www.readbyqxmd.com/read/28628201/designing-drug-response-experiments-and-quantifying-their-results
#13
Marc Hafner, Mario Niepel, Kartik Subramanian, Peter K Sorger
We developed a Python package to help in performing drug-response experiments at medium and high throughput and evaluating sensitivity metrics from the resulting data. In this article, we describe the steps involved in (1) generating files necessary for treating cells with the HP D300 drug dispenser, by pin transfer or by manual pipetting; (2) merging the data generated by high-throughput slide scanners, such as the Perkin Elmer Operetta, with treatment annotations; and (3) analyzing the results to obtain data normalized to untreated controls and sensitivity metrics such as IC50 or GR50 ...
June 19, 2017: Current Protocols in Chemical Biology
https://www.readbyqxmd.com/read/28625429/automated-anesthesia-carts-reduce-drug-recording-errors-in-medication-administrations-a-single-center-study-in-the-largest-tertiary-referral-hospital-in-china
#14
Ying Wang, Yingying Du, Yingying Zhao, Yang Ren, Wei Zhang
AIM: To clinically evaluate a type of patented automated anesthesia cart in medication administrations in anesthesia. MATERIALS AND METHODS: This was a prospectively randomized open label clinical trial. In 10 designated operating suits in the First Affiliated Hospital of Zhengzhou University, in China. 1066 cases originated from 10,812 medication administrations in anesthesia were randomized. 78 registered anesthesiologists managed the medication. The patients received medication administrations in anesthesia with either an automated or a conventional manual cart...
August 2017: Journal of Clinical Anesthesia
https://www.readbyqxmd.com/read/28623612/challenges-in-longitudinal-exposure-response-modeling-of-data-from-complex-study-designs-a-case-study-of-modeling-cdai-score-for-ustekinumab-in-patients-with-crohn-s-disease
#15
Chuanpu Hu, Omoniyi J Adedokun, Yang Chen, Philippe O Szapary, Christopher Gasink, Amarnath Sharma, Honghui Zhou
Informative exposure-response modeling of clinical endpoints is important in drug development to identify optimum dose and dosing regimens. Despite much recent progress in mechanism-based longitudinal modeling of clinical data, challenges remain in clinical trials of diseases such as Crohn's disease, where a commonly used composite endpoint Crohn's Disease Activity Index (CDAI) has considerable variation in its administration and scoring between different assessors and complex study designs typically include maintenance phases with randomized withdrawal re-randomizations and other response driven dose adjustments...
June 16, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28621487/simultaneous-quantification-of-imatinib-and-its-main-metabolite-n-demethyl-imatinib-in-human-plasma-by-liquid-chromatography-tandem-mass-spectrometry-and-its-application-to-therapeutic-drug-monitoring-in-patients-with-gastrointestinal-stromal-tumor
#16
Wei Zhuang, Hai-Bo Qiu, Xin-Meng Chen, Xiu-Hong Yuan, Li-Fang Yang, Xiao-Wei Sun, Xiao-Jun Zhou, Min Huang, Xue-Ding Wang, Zhi-Wei Zhou
AIM: To improve and validate a more stable and less time-consuming method based on liquid chromatography and tandem mass spectrometry (LC- MS/MS) for the quantitative measurement of Imatinib and its metabolite N-demethyl-Imatinib (NDI) in human plasma. METHODS: Separation of analytes was performed on a Waters XTerra RP18 column (50mm×2.1 mm i.d., 3.5 μm) with a mobile phase consisting of methanol/acetonitrile/ water (65:20:15, v/v/v) with 0.05% formic acid at a flow-rate of 0...
June 16, 2017: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/28620979/an-application-of-cifap-for-predicting-the-binding-affinity-of-chk1-inhibitors-derived-from-2-aminothiazole-4-carboxamide
#17
Dilan Konyar, Ozlem Erdas, Ferda Nur Alpaslan, Erdem Buyukbingol
Investigation of protein-ligand interactions obtained from experiments has a crucial part in the design of newly discovered and effective drugs. Analyzing the data extracted from known interactions could help scientists to predict the binding affinities of promising ligands before conducting experiments. The objective of this study is to advance the CIFAP (compressed images for affinity prediction) method, which is relevant to a protein-ligand model, identifying 2D electrostatic potential images by separating the binding site of protein-ligand complexes and using the images for predicting the computational affinity information represented by pIC50 values...
June 16, 2017: Journal of Molecular Recognition: JMR
https://www.readbyqxmd.com/read/28620937/testing-for-bioequivalence-of-highly-variable-drugs-from-tr-rt-crossover-designs-with-heterogeneous-residual-variances
#18
Qing Kang, Christopher I Vahl
Traditional bioavailability studies assess average bioequivalence (ABE) between the test (T) and reference (R) products under the crossover design with TR and RT sequences. With highly variable (HV) drugs whose intrasubject coefficient of variation in pharmacokinetic measures is 30% or greater, assertion of ABE becomes difficult due to the large sample sizes needed to achieve adequate power. In 2011, the FDA adopted a more relaxed, yet complex, ABE criterion and supplied a procedure to assess this criterion exclusively under TRR-RTR-RRT and TRTR-RTRT designs...
June 16, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/28616433/medication-errors-in-patients-with-enteral-feeding-tubes-in-the-intensive-care-unit
#19
Seyed Mojtaba Sohrevardi, Mohammad Hossein Jarahzadeh, Ehsan Mirzaei, Mahtabalsadat Mirjalili, Arefeh Dehghani Tafti, Behrooz Heydari
OBJECTIVE: Most patients admitted to Intensive Care Units (ICU) have problems in using oral medication or ingesting solid forms of drugs. Selecting the most suitable dosage form in such patients is a challenge. The current study was conducted to assess the frequency and types of errors of oral medication administration in patients with enteral feeding tubes or suffering swallowing problems. METHODS: A cross-sectional study was performed in the ICU of Shahid Sadoughi Hospital, Yazd, Iran...
April 2017: Journal of Research in Pharmacy Practice
https://www.readbyqxmd.com/read/28614668/cryptic-micro-heteroresistance-explains-m-tuberculosis-phenotypic-resistance
#20
John Z Metcalfe, Elizabeth Streicher, Grant Theron, Rebecca E Colman, Christopher Allender, Darrin Lemmer, Rob Warren, David M Engelthaler
BACKGROUND: Minority resistant M. tuberculosis subpopulations can be associated with phenotypic resistance, but are poorly detected by Sanger sequencing or commercial molecular diagnostic assays. The role of targeted next generation sequencing (NGS) in resolving these minor variant subpopulations is unclear. METHODS: We utilized Single Molecule-Overlapping Reads (SMOR), a targeted NGS approach that dramatically reduces sequencing error, to analyze primary cultured isolates phenotypically resistant to rifampin, fluoroquinolones, or aminoglycosides, but for which Sanger sequencing found no resistance-associated variants (RAVs) within respective resistance determining regions (RDRs) (Study Group)...
June 14, 2017: American Journal of Respiratory and Critical Care Medicine
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