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https://www.readbyqxmd.com/read/28641219/comparison-of-brand-versus-generic-antiepileptic-drug-adverse-event-reporting-rates-in-the-u-s-food-and-drug-administration-adverse-event-reporting-system-faers
#1
Md Motiur Rahman, Yasser Alatawi, Ning Cheng, Jingjing Qian, Annya V Plotkina, Peggy L Peissig, Richard L Berg, David Page, Richard A Hansen
OBJECTIVE: Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. METHODS: Events reported to the U...
June 13, 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28641169/association-between-switching-antiepileptic-drug-products-and-healthcare-utilization-a-systematic-review
#2
REVIEW
Patrick Kwan, André Palmini
AIMS: There is ongoing concern whether switching between different antiepileptic drug (AED) products may compromise patient care. We systematically reviewed changes in healthcare utilization following AED switch. METHODS: We searched MEDLINE and EMBASE databases (1980-October 2016) for studies that assessed the effect of AED switching in patients with epilepsy on outpatient visits, emergency room visits, hospitalization and hospital stay duration. RESULTS: A total of 14 articles met the inclusion criteria...
June 19, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28634699/cost-effective-analysis-of-disease-modifying-anti-rheumatic-drugs-in-rheumatoid-arthritis
#3
Ashit Syngle, Sudeep Kaur, Inderjeet Verma, Tanya Syngle, Vijaita Syngle
The main objective of the study was to perform the pharmacoeconomic analysis of synthetic disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients. A prospective, observational study was conducted in 98 rheumatoid arthritis (RA) patients meeting 2010 Rheumatoid Arthritis Classification Criteria. Treatment-naive RA patients were initiated on synthetic disease-modifying anti-rheumatic drugs (DMARD/s) and followed up for 3 months. Average cost-effectiveness analysis was done by taking Health Assessment Questionnaire Disability Index (HAQ-DI) score as a measure of effectiveness...
June 21, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28632475/generic-substitution-of-antiretrovirals-patients-and-health-care-providers-opinions
#4
Jennifer A Kieran, Eimear O'Reilly, Siobhan O'Dea, Colm Bergin, Aisling O'Leary
There is interest in introducing generic antiretroviral drugs (ARVs) into high-income countries in order to maximise efficiency in health care budgets. Studies examining patients' and providers' knowledge and attitudes to generic substitution in HIV are few. This was a cross-sectional, observational study with a convenience sample of adult HIV-infected patients and health care providers (HCPs). Data on demographics, knowledge of generic medicine and facilitators of generic substitution were collected. Descriptive and univariate analysis was performed using SPSS V...
January 1, 2017: International Journal of STD & AIDS
https://www.readbyqxmd.com/read/28630217/effectiveness-of-conservative-interventions-including-exercise-manual-therapy-and-medical-management-in-adults-with-shoulder-impingement-a-systematic-review-and-meta-analysis-of-rcts
#5
REVIEW
Ruedi Steuri, Martin Sattelmayer, Simone Elsig, Chloé Kolly, Amir Tal, Jan Taeymans, Roger Hilfiker
OBJECTIVE: To investigate the effectiveness of conservative interventions for pain, function and range of motion in adults with shoulder impingement. DESIGN: Systematic review and meta-analysis of randomised trials. DATA SOURCES: Medline, CENTRAL, CINAHL, Embase and PEDro were searched from inception to January 2017. STUDY SELECTION CRITERIA: Randomised controlled trials including participants with shoulder impingement and evaluating at least one conservative intervention against sham or other treatments...
June 19, 2017: British Journal of Sports Medicine
https://www.readbyqxmd.com/read/28629889/comparison-of-the-effectiveness-of-brand-name-and-generic-antipsychotic-drugs-for-treating-patients-with-schizophrenia-in-taiwan
#6
Chih-Wei Hsu, Sheng-Yu Lee, Liang-Jen Wang
The purpose of this nationwide population-based study is to compare the long-term effectiveness of brand-name antipsychotics with generic antipsychotics for treating schizophrenia. We identified patients with schizophrenia who were prescribed antipsychotics from a random sample of one million records from Taiwan's National Health Insurance database, observed between January 1, 2000 and December 31, 2012. Only those with no prior use of antipsychotics for at least 180days were included. We selected patients who were prescribed brand-name risperidone (N=404), generic risperidone (N=145), brand-name sulpiride (N=334), or generic sulpiride (N=991)...
June 16, 2017: Schizophrenia Research
https://www.readbyqxmd.com/read/28627427/144-week-efficacy-and-safety-of-a-once-daily-single-tablet-regimen-of-tenofovir-lamivudine-and-efavirenz-among-arv-na%C3%A3-ve-and-arv-experienced-hiv-1-infected-thai-adults
#7
Anchalee Avihingsanon, Wirach Maek-A-Nantawat, Sivaporn Gatechompol, Vorapot Sapsirisavat, Wanida Thiansanguankul, Jiratchaya Sophonphan, Narujakorn Thammajaruk, Sasiwimol Ubolyam, David M Burger, Kiat Ruxrungtham
OBJECTIVES: To assess the efficacy and safety of a new single tablet regimen(STR) of tenofovir disoproxil fumarate(TDF) 300mg, lamivudine(3TC) 300mg and efavirenz(EFV) 600mg in HIV-infected Thais. METHODS: This was a 144 week, prospective study among 51 treatment naïve and 49 experienced patients on separated pill of TDF, 3TC and EFV with HIV RNA<50 copies/ml. CD4, HIV RNA, liver, renal functions and lipid profiles were assessed at baseline, weeks 12, 24, 48 and then every 24 weeks...
June 13, 2017: International Journal of Infectious Diseases: IJID
https://www.readbyqxmd.com/read/28625684/brand-medications-and-medicare-part-d-how-eye-care-providers-prescribing-patterns-influence-costs
#8
Paula Anne Newman-Casey, Maria A Woodward, Leslie M Niziol, Paul P Lee, Lindsey B De Lott
PURPOSE: To quantify costs of eye care providers' Medicare Part D prescribing patterns for ophthalmic medications and to estimate the potential savings of generic or therapeutic drug substitutions and price negotiation. DESIGN: Retrospective cross-sectional study. PARTICIPANTS: Eye care providers prescribing medications through Medicare Part D in 2013. METHODS: Medicare Part D 2013 prescriber public use file and summary file were used to calculate medication costs by physician specialty and drug...
June 16, 2017: Ophthalmology
https://www.readbyqxmd.com/read/28625004/distribution-weighted-cost-effectiveness-analysis-using-lifetime-health-loss
#9
Ulrikke J V Hernæs, Kjell A Johansson, Trygve Ottersen, Ole F Norheim
BACKGROUND: It is widely acknowledged that concerns for the worse off need to be integrated with the concern for cost effectiveness in priority setting, and several countries are seeking to do so. In Norway, a comprehensive framework for priority setting was recently proposed to specify the worse off in terms of lifetime loss of quality-adjusted life-years (QALYs). However, few studies have shown how to calculate such health losses, how to integrate health loss into cost-effectiveness analyses (CEAs) and how such integration impacts the incremental cost-effectiveness ratios (ICERs)...
June 17, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28621572/changes-to-international-non-proprietary-names-for-antibody-therapeutics-2017-and-beyond-of-mice-men-and-more%C3%A2
#10
Paul W H I Parren, Paul J Carter, Andreas Plückthun
Active pharmaceutical substances require an International Nonproprietary Name (INN)assigned by the World Health Organization (WHO) to obtain market authorization as a medicinal product. INNsare selected to represent a unique, generic namefor a drug enablingunambiguous identification by stakeholders worldwide. INNs may be requested after initiating clinical development of an investigational drug. Pharmaceutical classes are indicated by a common stem or suffix. Currently, INNsfor monoclonal antibody-based drugs are recognized by the suffix, -mab,preceded by a source infixsuch as-xi- (chimeric),-zu- (humanized) or -u- (human) designating the species from which the antibody was derived...
June 16, 2017: MAbs
https://www.readbyqxmd.com/read/28615973/can-biosimilars-help-achieve-the-goals-of-us-health-care-reform
#11
REVIEW
Ralph Boccia, Ira Jacobs, Robert Popovian, Gilberto de Lima Lopes
The US Patient Protection and Affordable Care Act (ACA) aims to expand health care coverage, contain costs, and improve health care quality. Accessibility and affordability of innovative biopharmaceuticals are important to the success of the ACA. As it is substantially more difficult to manufacture them compared with small-molecule drugs, many of which have generic alternatives, biologics may increase drug costs. However, biologics offer demonstrated improvements in patient care that can reduce expensive interventions, thus lowering net health care costs...
2017: Cancer Management and Research
https://www.readbyqxmd.com/read/28607755/access-and-barriers-to-ms-care-in-latin-america
#12
REVIEW
Víctor M Rivera, Miguel Angel Macias
Multiple sclerosis (MS), an epidemiologically emergent disorder in Latin America (LATAM), poses substantial socioeconomic challenges to a region where most countries remain as economies in development. MS is not health priority despite its economic and communitarian impact with a relatively low prevalence. MS treatments in LATAM have evolved from earlier long-term oral steroids and immunosuppression protocols, to platform disease modifying therapies (DMTs), to the current landscape with more advanced therapeutic molecules...
January 2017: Multiple Sclerosis Journal—Experimental, Translational and Clinical
https://www.readbyqxmd.com/read/28607049/crystal-structures-and-atomic-model-of-nadph-oxidase
#13
Francesca Magnani, Simone Nenci, Elisa Millana Fananas, Marta Ceccon, Elvira Romero, Marco W Fraaije, Andrea Mattevi
NADPH oxidases (NOXs) are the only enzymes exclusively dedicated to reactive oxygen species (ROS) generation. Dysregulation of these polytopic membrane proteins impacts the redox signaling cascades that control cell proliferation and death. We describe the atomic crystal structures of the catalytic flavin adenine dinucleotide (FAD)- and heme-binding domains of Cylindrospermum stagnale NOX5. The two domains form the core subunit that is common to all seven members of the NOX family. The domain structures were then docked in silico to provide a generic model for the NOX family...
June 12, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28603636/make-up-a-missed-lesson-new-policy-to-ensure-the-interchangeability-of-generic-drugs-in-china
#14
Baobin Huang, Sarah L Barber, Mingzhe Xu, Shuanghong Cheng
Generic drugs should be interchangeable with originators in terms of quality and efficacy. With relative lower prices, generic drugs are playing an important role in controlling health expenditures and ensuring access. However, the widespread understanding of "cheap price equals low quality" has a negative impact on the acceptance of generic drugs. In China, medical doctors doubt the efficacy and quality of generic drugs manufactured domestically. To address these concerns, the Chinese State Council released a policy in 2016 to ensure the interchangeability by re-evaluating the quality and efficacy of generic drugs...
June 2017: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28599261/secretory-immunoglobulin-purification-from-whey-by-chromatographic-techniques
#15
Alexander Matlschweiger, Hannah Engelmaier, Gottfried Himmler, Rainer Hahn
Secretory immunoglobulins (SIg) are a major fraction of the mucosal immune system and represent potential drug candidates. So far, platform technologies for their purification do not exist. SIg from animal whey was used as a model to develop a simple, efficient and potentially generic chromatographic purification process. Several chromatographic stationary phases were tested. A combination of two anion-exchange steps resulted in the highest purity. The key step was the use of a small-porous anion exchanger operated in flow-through mode...
May 26, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28597866/delivery-of-antiretroviral-treatment-services-in-india-estimated-costs-incurred-under-the-national-aids-control-programme
#16
Reshu Agarwal, Bharat Bhushan Rewari, Suresh Shastri, Sharath Burugina Nagaraja, Abhilakh Singh Rathore
Competing domestic health priorities and shrinking financial support from external agencies necessitates that India's National AIDS Control Programme (NACP) brings in cost efficiencies to sustain the programme. In addition, current plans to expand the criteria for eligibility for antiretroviral therapy (ART) in India will have significant financial implications in the near future. ART centres in India provide comprehensive services to people living with HIV (PLHIV): those fulfilling national eligibility criteria and receiving ART and those on pre-ART care, i...
April 2017: WHO South-East Asia Journal of Public Health
https://www.readbyqxmd.com/read/28595756/impact-of-generic-substitution-on-levetiracetam-serum-concentration-a-prospective-study-in-an-outpatient-setting
#17
Arne Reimers, Patrik Olsson, Johanna Nilsson, Elin Hoff, Margareta Reis, Maria Strandberg, Anders Lundgren, Kristina Källén
BACKGROUND: Switching patients from a branded antiepileptic drug (AED) to a generic is often challenging. Several studies have shown that considerable proportions of patients report deteriorated seizure control or increased adverse effects, enforcing a switchback to the original drug. Since tolerability and seizure control usually correlate with AED serum concentrations, we examined the fluctuation of levetiracetam (LEV) serum concentrations in patients with epilepsy before and after generic substitution...
August 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28595755/generic-antiepileptic-drug-equivalence-the-journey-from-anecdotes-to-evidence
#18
EDITORIAL
Michael Privitera
No abstract text is available yet for this article.
August 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28593504/an-algorithm-to-identify-generic-drugs-in-the-fda-adverse-event-reporting-system
#19
Geetha Iyer, Sathiya Priya Marimuthu, Jodi B Segal, Sonal Singh
INTRODUCTION: Although generic drugs constitute approximately 88% of drugs prescribed in the US, there are no reliable methods to identify generic drugs in the US FDA Adverse Event Reporting System (FAERS). OBJECTIVE: The aim of this study was to develop an algorithm for identifying generic drugs in the FAERS. DATA SOURCE: We used 1237 adverse event reports for tamsulosin, levothyroxine, and amphetamine/dextroamphetamine from the publicly available FAERS from 2011-2013, and 277 source case narratives obtained from the FDA...
June 7, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28592234/design-and-rationale-for-the-warfa-trial-a-randomized-controlled-cross-over-trial-testing-the-therapeutic-equivalence-of-branded-and-generic-warfarin-in-atrial-fibrillation-patients-in-brazil
#20
Carolina Gomes Freitas, Michael Walsh, Álvaro Nagib Atallah
BACKGROUND: Warfarin is a commonly used anticoagulant. Whether a given dose of the different formulations of Brazilian warfarin will result in the same effect on the international normalized ratio (INR) is uncertain. The aim of the WARFA trial is to determine whether the branded and two generic warfarins available in Brazil differ in their effect on the INR. METHODS: WARFA is a cross-over RCT comparing three warfarins. The formulations tested are the branded Marevan® (Uniao Quimica/Farmoquimica) and two generic warfarin (manufactured respectively by Uniao Quimica Farmaceutica Nacional and Laboratorio Teuto Brasileiro)...
June 7, 2017: BMC Cardiovascular Disorders
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