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https://www.readbyqxmd.com/read/28654780/development-and-validation-of-an-icp-ms-method-for-the-determination-of-elemental-impurities-in-tp-6076-active-pharmaceutical-ingredient-api-according-to-usp-%C3%A2-232%C3%A2-%C2%AA-%C3%A2-233%C3%A2-%C2%AA
#1
Osama Chahrour, John Malone, Mark Collins, Vrushali Salmon, Catherine Greenan, Amy Bombardier, Zhongze Ma, Nick Dunwoody
The new guidelines of the United States pharmacopeia (USP), European pharmacopeia (EP) and international conference on harmonization (ICH) regulating elemental impurities limits in pharmaceuticals signify the end of unspecific analysis of metals as outlined in USP 〈231〉. The new guidelines specify both daily doses and concentration/limits of elemental impurities in pharmaceutical final products, active pharmaceutical ingredients (API) and excipients. In chapter USP 〈233〉 method implementation, validation and quality control during the analytical process are described...
June 20, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28654672/cost-effectiveness-analysis-of-oral-fentanyl-formulations-for-breakthrough-cancer-pain-treatment
#2
Paolo Angelo Cortesi, Lucia Sara D'Angiolella, Renato Vellucci, Massimo Allegri, Giuseppe Casale, Carlo Favaretti, Flavia Kheiraoui, Giancarlo Cesana, Lorenzo Giovanni Mantovani
Breakthrough cancer Pain (BTcP) has a high prevalence in cancer population. Patients with BTcP reported relevant health care costs and poor quality of life. The study assessed the cost-effectiveness of the available Oral Fentanyl Formulations (OFFs) for BTcP in Italy. A decision-analytical model was developed to estimate costs and benefits associated with treatments, from the Italian NHS perspective. Expected reductions in pain intensity per BTcP episodes were translated into, percentage of BTcP reduction, resource use and Quality-Adjusted-Life-Years (QALYs)...
2017: PloS One
https://www.readbyqxmd.com/read/28653408/evaluating-principal-surrogate-markers-in-vaccine-trials-in-the-presence-of-multiphase-sampling
#3
Ying Huang
This article focuses on the evaluation of vaccine-induced immune responses as principal surrogate markers for predicting a given vaccine's effect on the clinical endpoint of interest. To address the problem of missing potential outcomes under the principal surrogate framework, we can utilize baseline predictors of the immune biomarker(s) or vaccinate uninfected placebo recipients at the end of the trial and measure their immune biomarkers. Examples of good baseline predictors are baseline immune responses when subjects enrolled in the trial have been previously exposed to the same antigen, as in our motivating application of the Zostavax Efficacy and Safety Trial (ZEST)...
June 26, 2017: Biometrics
https://www.readbyqxmd.com/read/28653032/paraneoplastic-antigens-as-biomarkers-for-early-diagnosis-of-ovarian-cancer
#4
REVIEW
Madhumita Chatterjee, Laura C Hurley, Michael A Tainsky
Paraneoplastic syndromes are a group of rare disorders that can be triggered by an abnormal immune response to proteins from tumors of the lung, ovary, lymphatics, or breast. Paraneoplastic clinical syndromes affect < 1% of patients with cancer; however, the frequency of subclinical levels of paraneoplastic autoantibodies in asymptomatic patients with cancer is unknown. Numerous studies have reported that ovarian cancer patients show signs of paraneoplastic neurological syndromes (PNSs) before or after their cancers are diagnosed...
August 2017: Gynecologic Oncology Reports
https://www.readbyqxmd.com/read/28652474/rapid-screening-of-primary-aldosteronism-by-a-novel-chemiluminescent-immunoassay
#5
Ryo Morimoto, Yoshikiyo Ono, Yuta Tezuka, Masataka Kudo, Sachiko Yamamoto, Toshiaki Arai, Celso E Gomez-Sanchez, Hironobu Sasano, Sadayoshi Ito, Fumitoshi Satoh
Measurement of plasma aldosterone and renin concentration, or activity, is useful for selecting antihypertensive agents and detecting hyperaldosteronism in hypertensive patients. However, it takes several days to get results when measured by radioimmunoassay and development of more rapid assays has been long expected. We have developed chemiluminescent enzyme immunoassays enabling the simultaneous measurement of both aldosterone and renin concentrations in 10 minutes by a fully automated assay using antibody-immobilized magnetic particles with quick aggregation and dispersion...
June 26, 2017: Hypertension
https://www.readbyqxmd.com/read/28652294/internet-and-mobile-based-aftercare-and-follow-up-for-mental-disorders-protocol-of-a-systematic-review-and-meta-analysis
#6
Severin Hennemann, Sylvia Farnsteiner, Lasse Sander
INTRODUCTION: Mental disorders are characterised by a high likelihood of symptom recurrence or chronicity. Thus, in the vulnerable post-discharge phase, aftercare and follow-up aim at stabilising treatment effects, promoting functionality and preventing relapse or readmission. Internet- and mobile-based interventions may represent low threshold and effective extensions to aftercare in tertiary prevention of mental disorders. OBJECTIVES: The planned systematic review and meta-analysis aims to synthesise and analyse existing evidence on the effectiveness of psychological internet- and mobile-based aftercare or follow-up in maintaining treatment effects and/or preventing recurrence in adults with mental disorders...
June 26, 2017: BMJ Open
https://www.readbyqxmd.com/read/28652020/development-of-a-realtime-rt-pcr-assay-for-the-rapid-detection-of-influenza-a-h2-viruses
#7
Komissarov Andrey, Fadeev Artem, Kosheleva Anna, Grudinin Mikhail
Influenza and other acute respiratory infections are of great concern for public health, causing excessive morbidity and mortality throughout the world. Influenza virus A(H2N2), which caused a pandemic of so called "Asian flu" in 1957 was expelled from the human population by the new pandemic virus subtype H3N2 in 1968, however, influenza A(H2) viruses continue to circulate in wild birds and poultry. The lack of immunity in human population and the continued circulation of influenza A(H2) among animals makes emergence of a new pandemic virus possible...
June 23, 2017: Molecular and Cellular Probes
https://www.readbyqxmd.com/read/28652015/landscape-of-innovation-for-cardiovascular-pharmaceuticals-from-basic-science-to-new-molecular-entities
#8
Jennifer M Beierlein, Laura M McNamee, Michael J Walsh, Kenneth I Kaitin, Joseph A DiMasi, Fred D Ledley
PURPOSE: This study examines the complete timelines of translational science for new cardiovascular therapeutics from the initiation of basic research leading to identification of new drug targets through clinical development and US Food and Drug Administration (FDA) approval of new molecular entities (NMEs) based on this research. METHODS: This work extends previous studies by examining the association between the growth of research on drug targets and approval of NMEs associated with these targets...
June 23, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28652005/recent-trends-in-determination-of-thiamine-and-its-derivatives-in-clinical-practice
#9
REVIEW
Jaroslav Jenčo, Lenka Kujovská Krčmová, Dagmar Solichová, Petr Solich
Over the last five decades, many methods to analyze thiamine (vitamin B1) and its phosphorylated forms in urine, whole blood, serum, plasma and erythrocytes have been proposed. Some of the methods are presently used in routine practice, but analytical problems regarding reproducibility, standardization, lack of automation, time consuming procedures for pretreatment and analysis are often discussed. With modern approaches to bioanalysis in clinical research of vitamins, whole processes can be automated, making analysis less time consuming, with reduced consumption of solvents and samples...
June 17, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/28651747/the-rise-of-artificial-intelligence-and-the-uncertain-future-for-physicians
#10
EDITORIAL
C Krittanawong
Physicians in everyday clinical practice are under pressure to innovate faster than ever because of the rapid, exponential growth in healthcare data. "Big data" refers to extremely large data sets that cannot be analyzed or interpreted using traditional data processing methods. In fact, big data itself is meaningless, but processing it offers the promise of unlocking novel insights and accelerating breakthroughs in medicine-which in turn has the potential to transform current clinical practice [1]. Physicians can analyze big data, but at present it requires a large amount of time and sophisticated analytic tools such as supercomputers...
June 23, 2017: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/28651671/purpose-in-life-test-comparison-of-the-main-models-in-patients-with-mental-disorders
#11
Joaquín García-Alandete, José H Marco, Sandra Pérez
The aim of this study was to compare the main proposed models for the Purpose-In-Life Test, a scale for assessing meaning in life, in 229 Spanish patients with mental disorders (195 females and 34 males, aged 13-68, M = 34.43, SD = 12.19). Confirmatory factor-analytic procedures showed that the original model of the Purpose-In-Life Test, a 20-item unidimensional scale, obtained a better fit than the other analyzed models, SBχ2(df) = 326.27(170), SBχ2/df = 1.92, TLI = .93, CFI = .94, IFI = .94, RMSEA = .063 (90% CI [...
June 27, 2017: Spanish Journal of Psychology
https://www.readbyqxmd.com/read/28651442/a-randomized-single-blind-phase-i-trial-invictan-1-assessing-the-bioequivalence-and-safety-of-bi-695502-a-bevacizumab-biosimilar-candidate-in-healthy-subjects
#12
Willem Hettema, Christopher Wynne, Benjamin Lang, Mario Altendorfer, Niklas Czeloth, Ragna Lohmann, Sandeep Athalye, Dorothee Schliephake
OBJECTIVES: This Phase I trial (INVICTAN(®)-1) evaluated three-way bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, and reference product bevacizumab from two sources (US-approved Avastin(®), Genentech; EU-approved Avastin, Roche). METHODS: Healthy male subjects (N = 91) were randomized 1:1:1 to receive a single intravenous infusion of 1 mg/kg of BI 695502 or US- or EU-approved Avastin. An interim analysis was planned when ~50% of subjects were evaluable for the primary endpoint to determine if the prespecified criteria for bioequivalence were achieved; if demonstrated, the study could be stopped early...
June 27, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28651194/reference-intervals-for-hematological-and-biochemical-parameters-acute-phase-proteins-and-markers-of-oxidation-in-holstein-dairy-cows-around-3-and-30days-after-calving
#13
Pierangelo Moretti, Saverio Paltrinieri, Erminio Trevisi, Monica Probo, Annarita Ferrari, Andrea Minuti, Alessia Giordano
The establishment of specific reference intervals (RIs) is advisable when different metabolic conditions in the patient population are present or when existing RIs are not suitable. Holstein dairy cows, at the start of lactation, experience a negative energy balance and an altered immune function that can lead to different levels of blood parameters compared with cows at peak lactation. The aim of this study was the determination of RIs for Holstein cows at 3±1 and 30±3days in milk. To this aim, 145 cows, from 4 herds, were sampled...
June 20, 2017: Research in Veterinary Science
https://www.readbyqxmd.com/read/28651173/development-validation-and-clinical-application-of-a-method-for-the-simultaneous-quantification-of-lamivudine-emtricitabine-and-tenofovir-in-dried-blood-and-dried-breast-milk-spots-using-lc-ms-ms
#14
Catriona Waitt, Sujan Diliiy Penchala, Adeniyi Olagunju, Alieu Amara, Laura Else, Mohammed Lamorde, Saye Khoo
OBJECTIVES: To present the validation and clinical application of a LC-MS/MS method for the quantification of lamivudine (3TC), emtricitabine (FTC) and tenofovir (TFV) in dried blood spots (DBS) and dried breast milk spots (DBMS). METHODS: DBS and DBMS were prepared from 50 and 30μL of drug-spiked whole blood and human breast milk, respectively. Following extraction with acetonitrile and water, chromatographic separation utilised a Synergi polar column with a gradient mobile phase program consisting of 0...
June 17, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28650901/application-of-quality-by-design-approach-to-bioanalysis-development-of-a-method-for-elvitegravir-quantification-in-human-plasma
#15
Sara Baldelli, Giorgio Marrubini, Dario Cattaneo, Emilio Clementi, Matteo Cerea
BACKGROUND: The application of Quality by Design (QbD) principles in clinical laboratories can help to develop an analytical method through a systematic approach, providing a significant advance over the traditional heuristic and empirical methodology. In the present work, we applied for the first time the QbD concept in the development of a method for drug quantification in human plasma using elvitegravir as the test molecule. METHODS: The goal of the study was to develop a fast and inexpensive quantification method, with precision and accuracy as requested by the EMA guidelines on bioanalytical method validation...
June 22, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28650900/a-high-throughput-hplc-ms-ms-assay-for-the-detection-quantification-and-simultaneous-structural-confirmation-of-136-drugs-and-metabolites-in-human-urine
#16
Jacek Klepacki, Baharak Davari, Marion Boulet, Ryan Lizarraga, Uwe Christians
BACKGROUND: Due to its superior sensitivity and specificity, multi-analyte high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS) has become the gold standard in clinical toxicology. Although several qualitative and quantitative LC-MS/MS assays on various mass spectrometry platforms have been described in the literature, the majority of these methods either analyze only a limited number of compounds, and/or require tedious and time-consuming sample preparation...
June 22, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28649976/efficiency-of-analytical-and-sampling-based-uncertainty-propagation-in-intensity-modulated-proton-therapy
#17
N Wahl, P Hennig, H P Wieser, M Bangert
The sensitivity of intensity-modulated proton therapy (IMPT) treatment plans to uncertainties can be quantified and mitigated with robust/min-max and stochastic/probabilistic treatment analysis and optimization techniques. Those methods usually rely on sparse random, importance, or worst-case sampling. Inevitably, this imposes a trade-off between computational speed and accuracy of the uncertainty propagation. Here, we investigate analytical probabilistic modeling (APM) as an alternative for uncertainty propagation and minimization in IMPT that does not rely on scenario sampling...
June 26, 2017: Physics in Medicine and Biology
https://www.readbyqxmd.com/read/28649612/disentangling-the-neural-correlates-of-corticobasal-syndrome-and-corticobasal-degeneration-with-systematic-and-quantitative-ale-meta-analyses
#18
Franziska Albrecht, Sandrine Bisenius, Rodrigo Morales Schaack, Jane Neumann, Matthias L Schroeter
Corticobasal degeneration is a scarce neurodegenerative disease, which can only be confirmed by histopathological examination. Reported to be associated with various clinical syndromes, its classical clinical phenotype is corticobasal syndrome. Due to the rareness of corticobasal syndrome/corticobasal degeneration and low numbers of patients included in single studies, meta-analyses are particularly suited to disentangle features of the clinical syndrome and histopathology. Using PubMed, we identified 11 magnetic resonance imaging studies measuring atrophy in 22 independent cohorts with 200 patients contrasted to 318 healthy controls...
2017: NPJ Parkinson's Disease
https://www.readbyqxmd.com/read/28649312/the-eu-aims-longitudinal-european-autism-project-leap-design-and-methodologies-to-identify-and-validate-stratification-biomarkers-for-autism-spectrum-disorders
#19
Eva Loth, Tony Charman, Luke Mason, Julian Tillmann, Emily J H Jones, Caroline Wooldridge, Jumana Ahmad, Bonnie Auyeung, Claudia Brogna, Sara Ambrosino, Tobias Banaschewski, Simon Baron-Cohen, Sarah Baumeister, Christian Beckmann, Michael Brammer, Daniel Brandeis, Sven Bölte, Thomas Bourgeron, Carsten Bours, Yvette de Bruijn, Bhismadev Chakrabarti, Daisy Crawley, Ineke Cornelissen, Flavio Dell' Acqua, Guillaume Dumas, Sarah Durston, Christine Ecker, Jessica Faulkner, Vincent Frouin, Pilar Garces, David Goyard, Hannah Hayward, Lindsay M Ham, Joerg Hipp, Rosemary J Holt, Mark H Johnson, Johan Isaksson, Prantik Kundu, Meng-Chuan Lai, Xavier Liogier D'ardhuy, Michael V Lombardo, David J Lythgoe, René Mandl, Andreas Meyer-Lindenberg, Carolin Moessnang, Nico Mueller, Laurence O'Dwyer, Marianne Oldehinkel, Bob Oranje, Gahan Pandina, Antonio M Persico, Amber N V Ruigrok, Barbara Ruggeri, Jessica Sabet, Roberto Sacco, Antonia San José Cáceres, Emily Simonoff, Roberto Toro, Heike Tost, Jack Waldman, Steve C R Williams, Marcel P Zwiers, Will Spooren, Declan G M Murphy, Jan K Buitelaar
BACKGROUND: The tremendous clinical and aetiological diversity among individuals with autism spectrum disorder (ASD) has been a major obstacle to the development of new treatments, as many may only be effective in particular subgroups. Precision medicine approaches aim to overcome this challenge by combining pathophysiologically based treatments with stratification biomarkers that predict which treatment may be most beneficial for particular individuals. However, so far, we have no single validated stratification biomarker for ASD...
2017: Molecular Autism
https://www.readbyqxmd.com/read/28648785/lc-ms-bioanalysis-of-trastuzumab-and-released-emtansine-using-nano-surface-and-molecular-orientation-limited-nsmol-proteolysis-and-liquid-liquid-partition-in-plasma-of-trastuzumab-emtansine-treated-breast-cancer-patients
#20
Noriko Iwamoto, Akihiko Shimomura, Kenji Tamura, Akinobu Hamada, Takashi Shimada
Antibody-drug conjugates (ADCs) consist of monoclonal antibody and cytotoxic drugs covalently attached via stable crosslinkers, and are prospective antibody drugs for cancer therapy. To cover the overall pharmacokinetic understanding of ADCs, both the antibody and the released drugs are necessary for practical clinical observation. The nano-surface and molecular-orientation limited (nSMOL) proteolysis is a universal approach for antibody bioanalysis that enable Fab-selective proteolysis, which maintains antibody sequence specificity while decreasing excess analyte peptides...
June 19, 2017: Journal of Pharmaceutical and Biomedical Analysis
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