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https://www.readbyqxmd.com/read/28933038/methodological-considerations-for-comparison-of-brand-versus-generic-versus-authorized-generic-adverse-event-reports-in-the-us-food-and-drug-administration-adverse-event-reporting-system-faers
#1
Md Motiur Rahman, Yasser Alatawi, Ning Cheng, Jingjing Qian, Peggy L Peissig, Richard L Berg, David C Page, Richard A Hansen
BACKGROUND: The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. OBJECTIVE: To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. METHODS: Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG)...
September 20, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28930358/fabrication-and-characterization-of-a-3d-bioprinted-nanoparticle-hydrogel-hybrid-device-for-biomimetic-detoxification
#2
Maggie S Chen, Yue Zhang, Liangfang Zhang
A biomimetic micro/nanodevice is 3D bioprinted using polyethylene glycol (PEG) hydrogel as the supporting platform, along with the red blood cell (RBC) membrane-coated nanoparticles (RBC-NPs) encapsulated in the hydrogel as the detoxification mechanism. RBC-NPs are prepared through a nanoprecipitation and coating method and then mixed into the poly(ethylene glycol) diacrylate (PEGDA) monomer solution for 3D bioprinting through photopolymerization. This resulting detoxification device is engineered with multiple inner channels for the RBC-NPs to nonspecifically soak up the various toxins flowing through the channels...
September 20, 2017: Nanoscale
https://www.readbyqxmd.com/read/28929357/risk-based-bioequivalence-recommendations-for-antiepileptic-drugs
#3
REVIEW
Zhichuan Li, Lanyan Fang, Wenlei Jiang, Myong-Jin Kim, Liang Zhao
PURPOSE OF REVIEW: This review summarizes the current FDA practice in developing risk- and evidence-based product-specific bioequivalence guidances for antiepileptic drugs (AEDs). RECENT FINDINGS: FDA's product-specific guidance (PSG) for AEDs takes into account the therapeutic index of each AED product. Several PSGs for AEDs recommend fully replicated studies and a reference-scaled average bioequivalence (RS-ABE) approach that permit the simultaneous equivalence comparison of the mean and within-subject variability of the test and reference products...
September 19, 2017: Current Neurology and Neuroscience Reports
https://www.readbyqxmd.com/read/28929048/brand-versus-generic-dispensing-trend-for-ciprofloxacin-500-mg-levofloxacin-500-mg-and-moxifloxacin-400-mg-oral-dosage-forms-among-pharmacies-of-karachi-pakistan
#4
Fatima Zehra, Atta Abbas Naqvi, Sumbul Tasneem, Rizwan Ahmad, Niyaz Ahmad, Adnan Zia Shamsi, Naqiya Ali Asghar, Ghufran Ullah Khan
INTRODUCTION: Pakistan spends 0.7% of its gross domestic product on health. The public sector health-care system provides services to 22% of population thus paving the way for a dominant private sector. Patients in Pakistan mostly pay their medical expenses directly, and 64% of the health expenditures are borne by the household. Expenditure on medicine constitutes 43% of the total household expenditure. METHODS: A quantitative cross-sectional study was conducted in Karachi, Pakistan, for a month...
April 2017: International Journal of Pharmaceutical Investigation
https://www.readbyqxmd.com/read/28927712/real-world-data-on-rufinamide-treatment-in-patients-with-lennox-gastaut-syndrome-results-from-a-european-noninterventional-registry-study
#5
Marina Nikanorova, Christian Brandt, Stéphane Auvin, Rob McMurray
INTRODUCTION: Rufinamide is approved for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged ≥4years. The objective of this study was to provide real-world, long-term data on patients with LGS initiating rufinamide as add-on therapy and patients with LGS receiving other antiepileptic drugs (AEDs). METHODS: A Phase IV, noninterventional, multicenter registry study was conducted in patients with LGS aged ≥4years requiring modification to any AED treatment, including initiation of add-on rufinamide therapy...
September 15, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28927676/a-pilot-study-to-expand-treatment-of-chronic-hepatitis-c-in-resource-limited-settings
#6
REVIEW
Poonam Mathur, Emily Comstock, Edward McSweegan, Natalia Mercer, Nongthombam Suraj Kumar, Shyamasundaran Kottilil
The past five years have seen a revolution in the treatment of chronic hepatitis C, as short duration oral regimens of direct-acting antiviral drugs (DAAs), with nearly 100% cure rates for all genotypes, have replaced longer courses of ribavirin and injected interferon. Although initially very expensive, these DAAs are now becoming available in generic equivalents in countries with large numbers of chronically infected people, such as India. However, a number of obstacles may hinder the delivery of these drugs in resource-limited settings, including lack of access to diagnostic testing and the restriction of treatment to a small number of medical specialists...
September 16, 2017: Antiviral Research
https://www.readbyqxmd.com/read/28926562/generics-for-the-treatment-of-hepatitis-c-in-monoinfected-and-hiv-coinfected-patients-pros-and-cons
#7
Dario Cattaneo, Alessandro Fossati, Chiara Resnati, Massimo Galli, Cristina Gervasoni
The treatment of hepatitis C virus in monoinfected and HIV-coinfected patients has greatly changed over recent years as a result of the introduction of direct-acting antiviral agents (DAAs), which have revolutionized clinical outcomes and led to sustained virological response rates above 90-95%. The discovery of new molecules and the subsequent competition between pharmaceutical companies, together with the negotiated price policies pursued by many national health systems, have led to a gradual reduction in the cost of DAAs, and expand their use to an increasing number of patients, including those with mild liver damage...
September 19, 2017: AIDS Reviews
https://www.readbyqxmd.com/read/28926095/model-based-assessment-using-conventional-bioequivalence-limits-to-ensure-safety-and-efficacy-of-rivaroxaban-in-patients-undergoing-hip-or-knee-replacement
#8
Mario González-Sales, Lanyan Fang, Myong-Jin Kim, Liang Zhao
We evaluated whether the current bioequivalence limit is adequate to ensure safety and efficacy of rivaroxaban in patients under total hip arthroplasty and total knee arthroplasty based on its model informed benefit/risk profile. Clinical data from a total of 7145 patients from 3 phase 2 and 4 phase 3 clinical trials were included in the current model-based exposure-response analysis. The relationships between rivaroxaban exposure measurements (ie, minimum or trough, maximum, average concentration, and area under the concentration-time curve [AUC] at steady state) and clinical outcomes (ie, the probabilities of major bleeding [MB] and venous thromboembolism [VTE]) were modeled using NONMEM 7...
September 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28918665/considerations-in-establishing-bioequivalence-of-inhaled-compounds
#9
Irvin Mayers, Mohit Bhutani
Generic inhalers are often perceived as inferior to their branded counterparts; however, they are safe and effective if they can meet the regulatory requirements. The approach to assess bioequivalence (BE) in oral dosage form products is not sufficient to address the complexities of inhalational products (e.g., patient-device interface); hence, more considerations are needed and caution should be applied in determining BE of inhaled compounds. Areas covered: This review outlines the evaluation process for generic inhalers, explores the regulatory approaches in BE assessment, and highlights the considerations and challenges in the current in vitro and in vivo approaches (lung deposition, pharmacokinetic, pharmacodynamic/clinical studies, and patient-device interface) for establishing BE of inhaled compounds...
September 18, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28913785/evolution-of-patient-reported-outcomes-and-their-role-in-multiple-sclerosis-clinical-trials
#10
REVIEW
Cindy J Nowinski, Deborah M Miller, David Cella
Patient-reported outcomes (PROs) are playing an increasing role in multiple sclerosis (MS) research and practice, and are essential for understanding the effects that MS and MS treatments have on patients' lives. PROs are captured directly from patients and include symptoms, function, health status, and health-related quality of life. In this article, we review different categories (e.g., generic, targeted, preference-based) of PRO measures and considerations in selecting a measure. The PROs included in MS clinical research have evolved over time, as have the measures used to assess them...
September 14, 2017: Neurotherapeutics: the Journal of the American Society for Experimental NeuroTherapeutics
https://www.readbyqxmd.com/read/28906103/resolving-the-atomistic-modes-of-anle138b-inhibitory-action-on-peptide-oligomer-formation
#11
Dirk Matthes, Vytautas Gapsys, Christian Griesinger, Bert L de Groot
The di-phenyl-pyrazole compound anle138b is a known inhibitor of oligomeric aggregate formation in vitro and in vivo. Therefore, anle138b is considered a promising drug candidate to beneficially interfere with neurodegenerative processes causing devastating pathologies in humans. The atomistic details of the aggregation inhibition mechanism, however, are to date unknown since the ensemble of small nonfibrillar aggregates is structurally heterogeneous and inaccessible to direct structural characterization. Here, we set out to elucidate anle138b's mode of action using all-atom molecular dynamics simulations on the multi-microsecond timescale...
September 14, 2017: ACS Chemical Neuroscience
https://www.readbyqxmd.com/read/28906080/persistence-and-adherence-with-mirabegron-vs-antimuscarinics-in-overactive-bladder-retrospective-analysis-of-a-uk-general-practice-prescription-database
#12
Adrian S Wagg, Steve Foley, John Peters, Jameel Nazir, Leanne Kool-Houweling, Ludmila Scrine
INTRODUCTION AND OBJECTIVES: Persistence with antimuscarinic (AM) drugs prescribed for overactive bladder (OAB) is poor. This study aimed to compare persistence and adherence with the beta-3-adrenoceptor agonist mirabegron (MIR) vs AMs over 12 months. PATIENTS AND METHODS: This retrospective cohort analysis included patients aged ≥18 years who were prescribed MIR, or any AM. A 12-month look-back was used to assess inclusion eligibility. The primary end-point was persistence, defined as time to first discontinuation of index drug, during 1 year follow-up...
September 14, 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28906069/distribution-of-amyloid-like-and-oligomeric-species-from-protein-aggregation-kinetics
#13
Alexandra Silva, Bruno Almeida, Joana Sofia Fraga, Pablo Taboada, Pedro Miguel Martins, Sandra Ribeiro
Amyloid fibrils and soluble oligomers are two types of protein aggregates associated with neurodegeneration. Classic therapeutic strategies try to prevent the nucleation and spread of amyloid fibrils, whilst diffusible oligomers have emerged as promising drug targets affecting downstream pathogenic processes. We developed a generic protein aggregation model and validate it against measured compositions of fibrillar and non-fibrillar assemblies of ataxin-3, a protein implicated in Machado-Joseph disease. The derived analytic rate-law equations can be used to (i) identify the presence of parallel aggregation pathways and (ii) estimate the critical sizes of amyloid fibrils...
September 14, 2017: Angewandte Chemie
https://www.readbyqxmd.com/read/28898589/science-of-biosimilars
#14
R Donald Harvey
Biosimilar therapeutic proteins in oncology offer the potential to decrease costs while providing safety and efficacy profiles consistent with their respective reference or originator products. Biosimilars have a number of important differences from generic small-molecule drugs, including manufacturing processes that are unique from their reference products. These differences may affect biosimilars through posttranslational modifications that can occur in specific cellular production lines, and these modifications have potential effects on protein structure, function, clinical pharmacology, and immunogenicity...
September 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28895827/after-a-big-entrance-it-s-just-so-so-for-entresto
#15
Thomas Reinke
Some industry observers wonder why the wunderkind hasn't done more wonderfully on the market. As a brand name drug, Entresto costs substantially more than the generic ACE inhibitors and ARBs. GoodRx reports the average cash price for uninsured patients for Entresto is $504 per month, compared with $44 for enalapril.
July 2017: Managed Care
https://www.readbyqxmd.com/read/28895814/scott-gottlieb-believes-a-nimbler-speedier-fda-can-spur-competition-lower-prices
#16
Joseph Burns
The new head of the FDA might as well be starring alongside Tom Cruise in the latest installment of Mission Impossible. Since being named commissioner in May, Gottlieb has said he wants the FDA to speed the approval process for generic drugs, introduce competition to drive down prices, and get the opioid crisis under control.
August 2017: Managed Care
https://www.readbyqxmd.com/read/28895227/comparing-generic-drug-markets-in-europe-and-the-united-states-prices-volumes-and-spending
#17
COMPARATIVE STUDY
Olivier J Wouters, Panos G Kanavos, Martin McKEE
Policy Points: Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. CONTEXT: Rising drug prices are putting pressure on health care budgets...
September 2017: Milbank Quarterly
https://www.readbyqxmd.com/read/28894944/higher-out-of-pocket-expenses-for-tyrosine-kinase-inhibitor-therapy-is-associated-with-worse-health-related-quality-of-life-in-persons-with-chronic-myeloid-leukemia
#18
Qian Jiang, Haibo Wang, Lu Yu, Robert Peter Gale
PURPOSE: To explore health-related quality-of-life (HRQoL) profiles and identify socio-demographic and clinical variables associated with HRQoL in persons with chronic myeloid leukemia (CML) receiving tyrosine kinase inhibitors (TKIs). METHODS: A cross-sectional questionnaire was distributed to adults with chronic-phase CML receiving tyrosine kinase-inhibitor (TKI) therapy >3 months in complete cytogenetic response (CCyR). Respondents were anonymous. SF-36 Health Survey was used to measure HRQoL...
September 11, 2017: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/28892528/determinants-of-market-exclusivity-for-prescription-drugs-in-the-united-states
#19
Aaron S Kesselheim, Michael S Sinha, Jerry Avorn
The high prices of brand-name prescription drugs are a growing source of controversy in the United States. Manufacturers of brand-name drugs can command high prices because they are protected from generic competition by two types of government-granted monopoly rights. The first are patents on the drugs that generally define the basic period of brand-name-only sales. The second is awarded at the time of US Food and Drug Administration (FDA) approval and usually defines the minimum time until a generic can be sold...
September 11, 2017: JAMA Internal Medicine
https://www.readbyqxmd.com/read/28891489/generic-drugs-a-call-for-balanced-approach
#20
Rhishikesh Thakre, Pralhad Patil
No abstract text is available yet for this article.
August 15, 2017: Indian Pediatrics
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