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#1
Rebecca Voelker
No abstract text is available yet for this article.
July 18, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28719222/how-drug-life-cycle-management-patent-strategies-may-impact-formulary-management
#2
Jan Berger, Jeffrey D Dunn, Margaret M Johnson, Kurt R Karst, W Chad Shear
Drug manufacturers may employ various life-cycle management patent strategies, which may impact managed care decision making regarding formulary planning and management strategies when single-source, branded oral pharmaceutical products move to generic status. Passage of the Hatch-Waxman Act enabled more rapid access to generic medications through the abbreviated new drug application process. Patent expirations of small-molecule medications and approvals of generic versions have led to substantial cost savings for health plans, government programs, insurers, pharmacy benefits managers, and their customers...
October 2016: American Journal of Managed Care
https://www.readbyqxmd.com/read/28717743/chronic-myeloid-leukemia-in-india
#3
REVIEW
Prasanth Ganesan, Lalit Kumar
BACKGROUND: In the last decade, the use of imatinib has brought a paradigm shift in the management of chronic myeloid leukemia (CML). In India, imatinib has been available for more than a decade and has been made accessible to all segments of the population because of patient assistance programs and cheaper generic versions. Despite improvements in survival, there are unique challenges in the Indian context. METHODS: We reviewed published data pertaining to CML in India for the period of 1990 to 2016, using PubMed advanced search with the terms chronic myeloid leukemia and India, and included studies that reported on epidemiology, monitoring for therapy, treatment outcomes, and resistance...
February 2017: Journal of Global Oncology
https://www.readbyqxmd.com/read/28717397/how-do-we-avoid-disaster-when-exiting-the-european-medicines-agency-making-the-most-of-brexit-in-pharmaceutical-regulation
#4
EDITORIAL
Anthony James Hatswell
As the UK prepares to leave the EU, it must decide what path it is to take with a large number of regulatory and technical agencies who provide collaboration at the European level. In the case of pharmaceuticals, the European Medicines Agency (EMA) provides pan-European licencing for novel pharmaceuticals. Should the UK depart from the EMA system, this article highlights the loss to patients immediately (slower access to novel treatments), and in the long term by having no access to some novel products as companies choose not to launch in the UK...
2017: Ecancermedicalscience
https://www.readbyqxmd.com/read/28717153/proton-pump-inhibitors-and-the-risk-for-fracture-at-specific-sites-data-mining-of-the-fda-adverse-event-reporting-system
#5
Liwei Wang, Mei Li, Yuying Cao, Zhengqi Han, Xueju Wang, Elizabeth J Atkinson, Hongfang Liu, Shreyasee Amin
Proton pump inhibitors (PPIs) are widely used to treat gastric acid-related disorders. Concerns have been raised about potential fracture risk, especially at the hip, spine and wrist. However, fracture risk at other bone sites has not been as well studied. We investigated the association between PPIs and specific fracture sites using an aggregated knowledge-enhanced database, the Food and Drug Administration Adverse Event Reporting System Data Mining Set (AERS-DM). Proportional reporting ratio (PRR) was used to detect statistically significant associations (signals) between PPIs and fractures...
July 17, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28716156/generic-atorvastatin-is-as-effective-as-the-brand-name-drug-lipitor-%C3%A2-in-lowering-cholesterol-levels-a-cross-sectional-retrospective-cohort-study
#6
Alexander Loch, Jan Philipp Bewersdorf, Daniel Kofink, Dzafir Ismail, Imran Zainal Abidin, Ramesh Singh Veriah
BACKGROUND: In a world of ever increasing health care costs, generic drugs represent a major opportunity to ensure access to essential medicines for people who otherwise would be unable to afford them. However, some clinicians and patients are still questioning the safety and effectiveness of generic formulations compared to the proprietary drugs necessitating further systematic research analyzing the generic drugs' efficacy. Our objective was to compare the lipid lowering effects of generic and branded atorvastatin...
July 17, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/28715605/how-to-select-a-nanosimilar
#7
Alain Astier, Amy Barton Pai, Marco Bissig, Daan J A Crommelin, Beat Flühmann, Jean-Daniel Hecq, Josefien Knoeff, Hans-Peter Lipp, Alberto Morell-Baladrón, Stefan Mühlebach
Nanomedicines in the class of nonbiological complex drugs (NBCDs) are becoming increasingly available. Up to 23 nanomedicines have been approved, and approximately 50 are in clinical development. Meanwhile, the first nanosimilars have entered the market through the generic approval pathway, but clinical differences have been observed. Many healthcare professionals may be unaware of this issue and must be informed of these clinically relevant variances. This article provides a tool for rational decision making for the inclusion of nanomedicines into the hospital formulary, including defined criteria for evaluation of substitutability or interchangeability...
July 17, 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/28712612/patient-reported-outcome-and-observer-reported-outcome-assessment-in-rare-disease-clinical-trials-an-ispor-coa-emerging-good-practices-task-force-report
#8
Katy Benjamin, Margaret K Vernon, Donald L Patrick, Eleanor Perfetto, Sandra Nestler-Parr, Laurie Burke
BACKGROUND: Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. OBJECTIVE: To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials...
July 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28708443/regulatory-approaches-and-considerations-in-establishing-bioequivalence-of-inhaled-compounds
#9
Irvin Mayers, Mohit Bhutani
To be considered bioequivalent to their branded counterparts, generic drugs must meet the standards for bioequivalence (BE) described by the regulatory agencies. While BE of generic inhalational drugs can be evaluated using a similar approach as that for oral dosage from products or drugs that are delivered systemically, the approach is insufficient to address the complexities of inhalational products (e.g., localized site of action, device-patient interface). Therefore, more considerations are needed and caution should be applied when evaluating BE of inhaled compounds...
July 14, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28707284/fixed-dose-versus-off-label-combination-of-isosorbide-dinitrate-plus-hydralazine-hydrochloride-retrospective-propensity-matched-analysis-in-black-medicare-patients-with-heart-failure
#10
Elizabeth Ofili, Inder Anand, Richard Allen Williams, Ola Akinboboye, Liou Xu, Gary Puckrein
INTRODUCTION: Based upon the findings of the African-American Heart Failure Trial, the US Food and Drug Administration approved the fixed-dose combination of isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD) (FDC-ISDN/HYD) as a new drug for treatment of heart failure (HF) in self-identified African Americans. According to the FDA, FDC-ISDN/HYD has no therapeutic equivalent. However, off-label combinations of the separate generic drugs ISDN and HYD (OLC-ISDN+HYD) or isosorbide mononitrate (ISMN) and HYD (OLC-ISMN+HYD) are routinely substituted without any supporting outcome data...
July 13, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28706331/bioequivalence-of-generic-and-branded-amoxicillin-capsules-in-healthy-human-volunteers
#11
Priyanka Pathak, Vijaya A Pandit, Priti P Dhande
CONTEXT: The Medical Council of India urges doctors to prescribe generic drugs as far as possible. The Indian Medical Association had responded earlier saying that it requires guarantees on the quality of generic forms of drugs. Although no published scientific reports are available on the issue of therapeutic inequivalence, unconfirmed clinician accounts and newspaper reports of therapeutic inequivalence exist. AIM: This study was planned to ascertain whether bioequivalence of branded and generic amoxicillin capsule is comparable...
March 2017: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28705243/trends-in-treatment-with-antipsychotic-medication-in-relation-to-national-directives-in-people-with-dementia-a-review-of-the-swedish-context
#12
Staffan Karlsson, Ingalill Rahm Hallberg, Patrik Midlöv, Cecilia Fagerström
BACKGROUND: The aim of this study was to explore trends in treatment with antipsychotic medication in Swedish dementia care in nursing homes as reported in the most recent empirical studies on the topic, and to relate these trends to directives from the national authorities. METHODS: The study included two scoping review studies based on searches of electronic databases as well as the Swedish directives in the field. RESULTS: During the past decade, directives have been developed for antipsychotic medication in Sweden...
July 14, 2017: BMC Psychiatry
https://www.readbyqxmd.com/read/28696178/a-cheat-sheet-to-navigate-the-complex-maze-of-pharmaceutical-exclusivities-in-europe
#13
Marta Cavero Tomas, Bo Peng
As the two leading markets for pharmaceutical and biotech companies, the USA and Europe offer incentives to stimulate drug innovation, including patent and regulatory exclusivities. These exclusivities extend periods during which companies can market their products free of generic or other competition and recoup their investment. Pharmaceutical and biotech companies should carefully assess the different types of exclusivities available when developing regulatory submissions, patent filing strategies. The authors have previously summarized the USA exclusivities in an earlier publication...
July 11, 2017: Pharmaceutical Patent Analyst
https://www.readbyqxmd.com/read/28695605/returns-to-scientific-publications-for-pharmaceutical-products-in-the-united-states
#14
Julia F Slejko, Anirban Basu, Sean D Sullivan
Drug-specific clinical and health economic and outcomes research (HEOR) publications have amassed, but their effect on drug sales is largely unknown. We estimated the impact of publications on pharmaceutical sales in 3 markets (statins, rheumatoid arthritis, and asthma drugs) with varying generic competition. An event-study approach with fixed effects and difference-in-fixed-effects modeling was used to estimate the causal effects of drug-specific publications on subsequent quarter's drug-specific sales and volume...
July 10, 2017: Health Economics
https://www.readbyqxmd.com/read/28695464/improving-adherence-to-treatment-and-reducing-economic-costs-of-hypertension-the-role-of-olmesartan-based-treatment
#15
Francesco Vittorio Costa
Poor adherence to antihypertensive treatment is the single most important factor of unsatisfactory blood pressure (BP) control. This review focuses on therapy-related factors affecting adherence and suggests how to improve it with a wise choice of treatment schedule. Complex drug treatment schemes, poor tolerability and drug substitutions are frequent causes of poor adherence which, in turn, causes insufficient BP control, greater incidence of cardiovascular events and, finally, higher global health costs...
July 10, 2017: High Blood Pressure & Cardiovascular Prevention: the Official Journal of the Italian Society of Hypertension
https://www.readbyqxmd.com/read/28691382/variation-in-prescription-drug-coverage-for-triptans-analysis-of-insurance-formularies
#16
Mia T Minen, Kate Lindberg, Aisha Langford, Elizabeth Loder
OBJECTIVES: To analyze triptan coverage by insurers to examine (1) possible disparities in coverage for different formulations (oral, intranasal, etc) and (2) quantity limits and stepped care requirements to obtain triptans. BACKGROUND: Triptans are FDA approved migraine abortive medications. Patients frequently state that they have difficulty accessing triptans prescribed to them. METHODS: We searched the 2015 drug formularies of commercial and government health insurers providing coverage in NY State...
July 9, 2017: Headache
https://www.readbyqxmd.com/read/28687987/evaluation-of-the-crystallization-tendency-of-commercially-available-amorphous-tacrolimus-formulations-exposed-to-different-stress-conditions
#17
Niraj S Trasi, Hitesh S Purohit, Lynne S Taylor
PURPOSE: Tacrolimus, an immunosuppressant, is a poorly water soluble compound whereby the commercially available capsule formulations contain the drug in amorphous form. The goal of this study was to evaluate the robustness of the innovator product and five generic formulations to crystallization following storage at stress conditions. METHODS: Products were purchased from a pharmacy and stored at 40°C/75% relative humidity (RH), open dish conditions. Crystallinity was determined using X-ray diffraction...
July 7, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28686780/a-survey-assessment-of-us-dermatologists-perception-of-biosimilars
#18
Alexandra Barsell, Monica Rengifo-Pardo, Alison Ehrlich
<p>BACKGROUND: Biologics have transformed the treatment of psoriasis and psoriatic arthritis, but at a significant cost to payers and patients. The introduction of biosimilars into the US market could reduce costs while increasing access to biologic medications.</p> <p>OBJECTIVE: We sought to identify gaps in biosimilar knowledge and perception among US dermatologists.</p> <p>METHODS: An online survey was sent to dermatologists from January to April 2015.</p> <p>RESULTS: Ninety-seven US dermatologists responded, of which 84% state they prescribe biologics in their practice...
June 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28686057/patient-relevant-outcomes-associated-with-generic-tamsulosin-levothyroxine-and-amphetamine-in-the-fda-adverse-event-reporting-system-a-pilot-study
#19
Sathiya Priya Marimuthu, Geetha Iyer, Jodi B Segal, Sonal Singh
AIM: Patient-reported outcomes associated with adverse events (AEs) reported with generics have not been evaluated. To map AEs associated with generics to the NIH Patient-reported Outcomes Measurement Information System. METHODS: We mapped 381 AEs from 148 case reports of generic tamsulosin, levothyroxine and amphetamine/dextroamphetamine to the physical, mental and social domain of the NIH Patient-Reported Outcomes Measurement Information System after reviewing 1237 case reports in the US FDA's Adverse Event Reporting System (FAERS; 2011-2013)...
July 7, 2017: Journal of Comparative Effectiveness Research
https://www.readbyqxmd.com/read/28685150/genetic-mutations-and-epigenetic-modifications-driving-cancer-and-informing-precision-medicine
#20
REVIEW
Krysta Mila Coyle, Jeanette E Boudreau, Paola Marcato
Cancer treatment is undergoing a significant revolution from "one-size-fits-all" cytotoxic therapies to tailored approaches that precisely target molecular alterations. Precision strategies for drug development and patient stratification, based on the molecular features of tumors, are the next logical step in a long history of approaches to cancer therapy. In this review, we discuss the history of cancer treatment from generic natural extracts and radical surgical procedures to site-specific and combinatorial treatment regimens, which have incrementally improved patient outcomes...
2017: BioMed Research International
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