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generics drugs AND quality

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https://www.readbyqxmd.com/read/29121918/-no-generics-doctor-the-perspective-of-general-practitioners-in-two-french-regions
#1
Béatrice Riner, Adèle Bussy, Jeannie Hélène-Pelage, Nycrees Moueza, Sébastien Lamy, Philippe Carrère
BACKGROUND: Generic medicines are essential to controlling health expenditures. Their market share is still small in France. The discourse and practices of prescribers may play a major role in their use. The purpose of this study was to explore the knowledge, attitudes and practices of general practitioners (GPs) toward generic medicines in two French regions with the lowest penetration rate of these products. METHODS: An observational study was carried out from October 2015 to February 2016 in Guadeloupe and Martinique...
November 9, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/29110842/patient-reported-outcome-measures-proms-in-the-management-of-lung-cancer-a-systematic-review
#2
REVIEW
Youssef Ben Bouazza, Ibrahim Chiairi, Ouiam El Kharbouchi, Lesley De Backer, Greetje Vanhoutte, Annelies Janssens, Jan P Van Meerbeeck
Lung cancer is often associated with a poor quality of life, as reflected by patient-reported outcome measures (PROMs). The aim of this paper is to describe and compare the PROMs that are available. In this manuscript, we review the impact of PROMs on the management of lung cancer. Quality of the study and risk of bias were assessed using the appraisal tools recommended by the Dutch Cochrane Center. Out of 51 studies included in this review, ten instruments were identified and categorized as either generic, cancer- or lung cancer-specific...
November 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/29110294/chemometric-methods-to-quantify-1d-and-2d-nmr-spectral-differences-among-similar-protein-therapeutics
#3
Kang Chen, Junyong Park, Feng Li, Sharadrao M Patil, David A Keire
NMR spectroscopy is an emerging analytical tool for measuring complex drug product qualities, e.g., protein higher order structure (HOS) or heparin chemical composition. Most drug NMR spectra have been visually analyzed; however, NMR spectra are inherently quantitative and multivariate and thus suitable for chemometric analysis. Therefore, quantitative measurements derived from chemometric comparisons between spectra could be a key step in establishing acceptance criteria for a new generic drug or a new batch after manufacture change...
November 6, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/29107620/lacking-quality-in-research-is-behavioral-neuroscience-affected-more-than-other-areas-of-biomedical-science
#4
Anton Bespalov, Thomas Steckler
There are many reasons why novel therapeutics fail in clinical trials but these failures are often attributed to lacking quality of preclinical data. These problems are not limited to any specific therapeutic area, academic or industrial research and are due in large part to several generic factors influencing research quality (e.g., related to definition of pre-specified endpoints, principles of study design and analysis, biased reporting, and lack of proper training). Yet, Neuroscience drug discovery is often said to be affected more than the other fields...
October 28, 2017: Journal of Neuroscience Methods
https://www.readbyqxmd.com/read/29101617/quality-of-medication-information-in-discharge-summaries-from-hospitals-an-audit-of-electronic-patient-records
#5
Beate Hennie Garcia, Berit Svendsen Djønne, Frode Skjold, Ellen Marie Mellingen, Trine Iversen Aag
Background Low quality of medication information in discharge summaries from hospitals may jeopardize optimal therapy and put the patient at risk for medication errors and adverse drug events. Objective To audit the quality of medication information in discharge summaries and explore factors associated with the quality. Setting Helgelandssykehuset Mo i Rana, a rural hospital in central Norway. Method For each month in 2013, we randomly selected 60 discharge summaries from the Department of Medicine and Surgery (totally 720) and evaluated the medication information using eight Norwegian quality criteria...
November 3, 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/29079338/advances-in-experimental-and-mechanistic-computational-models-to-understand-pulmonary-exposure-to-inhaled-drugs
#6
Per Bäckman, Sumit Arora, William Couet, Ben Forbes, Wilbur de Kruijf, Amrit Paudel
Prediction of local exposure following inhalation of a locally acting pulmonary drug is central to the successful development of novel inhaled medicines, as well as generic equivalents. This work provides a comprehensive review of the state of the art with respect to multiscale computer models designed to provide a mechanistic prediction of local and systemic drug exposure following inhalation. The availability and quality of underpinning in vivo and in vitro data informing the computer based models is also considered...
October 25, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29076742/impact-of-the-us-fda-biopharmaceutics-classification-system-bcs-guidance-on-global-drug-development
#7
Mehul U Mehta, Ramana S Uppoor, Dale P Conner, Paul Seo, Jayabharathi Vaidyanathan, Donna A Volpe, Ethan Stier, Dakshina Chilukuri, Angelica Dorantes, Tapash Ghosh, Haritha Mandula, Kimberly Raines, Pariban Dhanormchitphong, Janet Woodcock, Lawrence X Yu
The FDA guidance on application of the biopharmaceutics classification system (BCS) for waiver of in vivo bioequivalence (BE) studies was issued in August 2000. Since then, this guidance has created worldwide interest among biopharmaceutical scientists in regulatory agencies, academia, and industry toward its implementation and further expansion. This article describes how the review implementation of this guidance was undertaken at the FDA and results of these efforts over last dozen years or so across the new, and the generic, drug domains are provided...
November 7, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/29073983/drug-policy-in-poland
#8
Karina Jahnz-Różyk, Pawel Kawalec, Krzysztof Malinowski, Katarzyna Czok
We presented a general overview of the health care system as well as the pricing and reimbursement environment in Poland. Poland aims to ensure proper access to safe and effective medicines while reducing patients' share in treatment costs. Nevertheless, the co-payment for pharmacotherapy is still high (more than 60%). The key policymaker and regulator in the system is the Ministry of Health, which is supported by the Polish Agency for Health Technology Assessment and Tariff System (Agencja Oceny Technologii Medycznych i Taryfikacji), responsible for evaluating applicant drugs, and the Economic Commission, responsible for negotiating the official sales prices and conditions for reimbursement with pharmaceutical companies (e...
September 2017: Value in Health Regional Issues
https://www.readbyqxmd.com/read/29073981/applying-multi-criteria-decision-analysis-mcda-simple-scoring-as-an-evidence-based-hta-methodology-for-evaluating-off-patent-pharmaceuticals-opps-in-emerging-markets
#9
Diana Brixner, Nikos Maniadakis, Zoltán Kaló, Shanlian Hu, Jie Shen, Kalman Wijaya
Off-patent pharmaceuticals (OPPs) represent more than 60% of the pharmaceutical market in many emerging countries, where they are frequently evaluated primarily on cost rather than with health technology assessment. OPPs are assumed to be identical to the originators. Branded and unbranded generic versions can, however, vary from the originator in active pharmaceutical ingredients, dosage, consistency formulation, excipients, manufacturing processes, and distribution, for example. These variables can alter the efficacy and safety of the product, negatively impacting both the anticipated cost savings and the population's health...
September 2017: Value in Health Regional Issues
https://www.readbyqxmd.com/read/29067750/quality-of-life-of-biliary-atresia-after-living-donor-liver-transplant-in-japan
#10
Ryota Kikuchi, Koichi Mizuta, Taizen Urahashi, Yukihiro Sanada, Naoya Yamada, Erika Onuma, Iori Sato, Kiyoko Kamibeppu
BACKGROUND: Health-related quality of life (HRQOL) is an important outcome in solid organ transplantation. This study evaluated and explored the factors of generic and transplant-specific HRQOL in Japanese pediatric and adolescent patients with biliary atresia (BA) after living donor liver transplant (LDLT). METHODS: A cross-sectional survey using anonymous questionnaires was completed between April and July 2015. Patients' medical records were accessed. The Japanese version of Pediatric Quality of Life Inventory(™) Generic Core Scales and Transplant Modules (child self-report and parent proxy-report) was administered...
October 25, 2017: Pediatrics International: Official Journal of the Japan Pediatric Society
https://www.readbyqxmd.com/read/29057664/the-8th-annual-symposium-on-clinical-pharmaceutical-solutions-through-analysis-clinical-and-pharmaceutical-success-from-discovery-to-regulatory-approval-biomarkers-modeling-and-analytical-technologies
#11
Tianyi Tee Zhang, Naidong Weng, Mike Lee
Renaissance Shanghai Pudong Hotel, Shanghai, China, 12-14 April 2017 The 8th Annual Shanghai Symposium on Clinical and Pharmaceutical Solutions through Analysis (CPSA): Clinical and Pharmaceutical Success from Discovery to Regulatory Approval: Biomarkers, Modeling and Analytical Technologies (CPSA Shanghai 2017) was held on 12-14 April 2017 in Shanghai, China. The meeting was featured with highly interactive events including diversified symposia, workshops, roundtable discussions, conference awards and poster sessions...
October 21, 2017: Bioanalysis
https://www.readbyqxmd.com/read/29047143/rising-drug-costs-drives-the-growth-of-pharmacy-benefit-managers-exclusion-lists-are-exclusion-decisions-value-based
#12
Joshua P Cohen, Christelle El Khoury, Christopher-Paul Milne, Sandra M Peters
OBJECTIVE: We examine whether drugs' excluded versus recommended status on pharmacy benefit manager exclusion lists corresponds to evidence from cost-effectiveness analyses, lack of evidence, or rebates. DATA SOURCES: To find cost-effectiveness data for drugs on 2016 exclusion lists of CVS Caremark and Express Scripts, we searched the Tufts Cost-Effectiveness Analysis Registry and the peer-reviewed literature. STUDY DESIGN: For each excluded and recommended drug, we compared the mean cost-per-QALY, and we calculated the difference between the numbers of excluded and recommended drugs for which we could find no cost-effectiveness evidence...
October 18, 2017: Health Services Research
https://www.readbyqxmd.com/read/29017463/subjective-health-expectations-of-patients-with-age-related-macular-degeneration-treated-with-antivegf-drugs
#13
Márta Péntek, Valentin Brodszky, Zsolt Biró, Zsófia Kölkedi, Árpád Dunai, János Németh, Petra Baji, Fanni Rencz, László Gulácsi, Miklós D Resch
BACKGROUND: Subjective expectations regarding future health may influence patients' judgement of current health and treatment effects, as well as adherence to therapies in chronic diseases. We aimed to explore subjective expectations on longevity and future health-related quality of life (HRQOL) of patients with age-related macular degeneration (AMD) treated with antiVEGF injections and analyse the influencing factors. METHODS: Consecutive AMD patients in two ophthalmology centres were included...
October 10, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/28991670/follow-on-products-for-treatment-of-multiple-sclerosis-in-latin-america-an-update
#14
REVIEW
Jorge Correale
Both proprietary and non-proprietary medicines are expected to undergo rigorous pre-approval testing and both should meet stringent health authority regulatory requirements related to quality to obtain approval. Non-proprietary (also known as copy or generic) medicines, which base their authorization and use on the proprietary documentation and label, are often viewed as a means to help lower cost and thus increase patient access. If these medicines fail to meet quality standards, such as good manufacturing practice and bioequivalence (in humans), they are then defined as substandard copies and can pose serious risks to patients in terms of safety and efficacy...
October 15, 2017: Journal of the Neurological Sciences
https://www.readbyqxmd.com/read/28964756/differences-in-health-related-quality-of-life-between-hiv-positive-and-hiv-negative-people-in-zambia-and-south-africa-a-cross-sectional-baseline-survey-of-the-hptn-071-popart-trial
#15
Ranjeeta Thomas, Ronelle Burger, Abigail Harper, Sarah Kanema, Lawrence Mwenge, Nosivuyile Vanqa, Nomtha Bell-Mandla, Peter C Smith, Sian Floyd, Peter Bock, Helen Ayles, Nulda Beyers, Deborah Donnell, Sarah Fidler, Richard Hayes, Katharina Hauck
BACKGROUND: The life expectancy of HIV-positive individuals receiving antiretroviral therapy (ART) is approaching that of HIV-negative people. However, little is known about how these populations compare in terms of health-related quality of life (HRQoL). We aimed to compare HRQoL between HIV-positive and HIV-negative people in Zambia and South Africa. METHODS: As part of the HPTN 071 (PopART) study, data from adults aged 18-44 years were gathered between Nov 28, 2013, and March 31, 2015, in large cross-sectional surveys of random samples of the general population in 21 communities in Zambia and South Africa...
November 2017: Lancet Global Health
https://www.readbyqxmd.com/read/28957849/substandard-drugs-among-five-common-antihypertensive-generic-medications-an-analysis-from-10-african-countries
#16
Diane Macquart de Terline, Bara I Diop, Melisande Bernard, Bernard Do, Méo S Ikama, Roland N'guetta, Dadhi M Balde, Yessoufou Tchabi, Abdallahi Sidi Aly, Ibrahim Ali Toure, Patrick Zabsonre, Jean-Marc F Damorou, Jean-Laurent Takombe, Kumar Narayanan, Christine Fernandez, Muriel Tafflet, Pierre-François Plouin, Jean-Philippe Empana, Eloi Marijon, Xavier Jouven, Marie Antignac
OBJECTIVE: Hypertension results in more deaths than any other risk factor and has been on the rise in sub-Saharan Africa over the past few decades. Generic drugs have helped improve accessibility and affordability of antihypertensive therapy in developing countries. However, assessment of quality standards of these products is important. We performed a quality assessment of five commonly used antihypertensive generic drugs in 10 sub-Saharan African countries and studied the impact of price on quality...
September 27, 2017: Journal of Hypertension
https://www.readbyqxmd.com/read/28957559/cost-effectiveness-analysis-of-hla-b-58-01-genotyping-prior-to-initiation-of-allopurinol-for-gout
#17
REVIEW
Catrin O Plumpton, Ana Alfirevic, Munir Pirmohamed, Dyfrig A Hughes
Objective: To determine whether prospective testing for HLA-B*58:01, as a strategy to prevent serious adverse reactions to allopurinol in patients with gout, is cost-effective from the perspective of the National Health Service in the UK. Methods: A systematic review and meta-analysis for the association of HLA-B*58:01 with cutaneous and hypersensitivity adverse drug reactions informed a decision analytic and Markov model to estimate lifetime costs and outcomes associated with testing vs standard care (with febuxostat prescribed for patients who test positive)...
October 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28949401/kronisk-myeloisk-leukemi-f%C3%A3-rebild-f%C3%A3-r-m%C3%A3-lstyrd-terapi-revolutionerande-%C3%A3-verlevnadsvinster-med-definitiv-bot-i-sikte-och-kraftigt-f%C3%A3-rb%C3%A3-ttrad-h%C3%A3-lsoekonomi
#18
Johan Richter, Leif Stenke
Chronic myeloid leukemia - a model disease for targeted therapy Chronic myeloid leukemia (CML) pioneered as the first human malignancy linked to a specific cytogenetic aberration (the Philadelphia chromosome), which led the way to specific targeted therapies with imatinib (Glivec) and later tyrosine kinase inhibitors (TKI). Continuous TKI administration, blocking the oncogenic fusion protein Bcr-Abl, has revolutionized the outcome of CML, transforming an almost uniformly deadly disease into a chronic disorder with a near to normal life expectancy for many patients...
September 21, 2017: Läkartidningen
https://www.readbyqxmd.com/read/28947411/information-about-medications-in-the-district-of-bamako-mali
#19
M Koné, T Diallo, A Dénou, B F Coulibaly, B Dackouo, B Coulibaly, B Y Koumaré, A Maiga
The aim of our study was to investigate the quality of information about pharmaceutical products in Mali. The study surveyed 98 prescribers, 60 pharmacists, and the package inserts of a basket of 30 generic medicines, compared to those of the corresponding proprietary versions. We made a rational choice of 98 doctors from various specialties and levels of the health system and randomly selected 60 of the 215 pharmacies in the district of Bamako (Mali). A rational sampling of generic medicines provided us with a basket of 30 drug notices for the antimalarial, antibiotic, antalgic, antipyretic, and anti-inflammatory agents used most in the Republic of Mali...
August 1, 2017: Médecine et Santé Tropicales
https://www.readbyqxmd.com/read/28944730/optimization-of-medication-use-at-accountable-care-organizations
#20
Chrisanne Wilks, Erik Krisle, Kimberly Westrich, Kristina Lunner, David Muhlestein, Robert Dubois
BACKGROUND: Optimized medication use involves the effective use of medications for better outcomes, improved patient experience, and lower costs. Few studies systematically gather data on the actions accountable care organizations (ACOs) have taken to optimize medication use. OBJECTIVES: To (a) assess how ACOs optimize medication use; (b) establish an association between efforts to optimize medication use and achievement on financial and quality metrics; (c) identify organizational factors that correlate with optimized medication use; and (d) identify barriers to optimized medication use...
October 2017: Journal of Managed Care & Specialty Pharmacy
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