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Efficacy of generic drugs

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https://www.readbyqxmd.com/read/29895310/developing-a-measure-of-polypharmacy-appropriateness-in-primary-care-systematic-review-and-expert-consensus-study
#1
Jenni Burt, Natasha Elmore, Stephen M Campbell, Sarah Rodgers, Anthony J Avery, Rupert A Payne
BACKGROUND: Polypharmacy is an increasing challenge for primary care. Although sometimes clinically justified, polypharmacy can be inappropriate, leading to undesirable outcomes. Optimising care for polypharmacy necessitates effective targeting and monitoring of interventions. This requires a valid, reliable measure of polypharmacy, relevant for all patients, that considers clinical appropriateness and generic prescribing issues applicable across all medications. Whilst there are several existing measures of potentially inappropriate prescribing, these are not specifically designed with polypharmacy in mind, can require extensive clinical input to complete, and often cover a limited number of drugs...
June 13, 2018: BMC Medicine
https://www.readbyqxmd.com/read/29791921/does-gastroplus-support-similarity-and-dissimilarity-factors-of-in-vitro-in-vivo-prediction-in-biowaiver-studies-a-lower-strength-amlodipine-as-a-model-drug
#2
Abdel Naser Zaid, Naser Shraim, Asmaa Radwan, Nidal Jaradat, Samah Hirzallah, Ibrahim Issa, Aya Khraim
BACKGROUND: Many generic pharmaceutical products are currently available on the market place worldwide. Recently, there is a growing concern on the quality and efficacy of generic products. However, health care professionals such as physicians and pharmacists are in difficult situations to choose among alternatives. PURPOSE: The aim of this study is to assess the effectiveness of the in silico technique (Gastro Plus® ) in the biowaiver study and whether similarity and dissimilarity factors ( f 2 and f 1 respectively) are effective in this regard...
May 23, 2018: Drug Research
https://www.readbyqxmd.com/read/29769386/global-acceptance-of-biosimilars-importance-of-regulatory-consistency-education-and-trust
#3
REVIEW
Eduardo Cazap, Ira Jacobs, Ali McBride, Robert Popovian, Karol Sikora
Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics...
May 16, 2018: Oncologist
https://www.readbyqxmd.com/read/29755792/sofosbuvir-plus-daclatasvir-in-treatment-of-chronic-hepatitis-c-genotype-4-infection-in-a-cohort-of-egyptian-patients-an-experiment-the-size-of-egyptian-village
#4
Ossama Ashraf Ahmed, Eslam Safwat, Mohamed Omar Khalifa, Ahmed I Elshafie, Mohamed Hassan Ahmed Fouad, Mohamed Magdy Salama, Gina Gamal Naguib, Mohamed Mahmoud Eltabbakh, Ahmed Fouad Sherief, Sherief Abd-Elsalam
Background and Aims: As indicated by the World Health Organization (WHO), Egypt is positioned as the country with the world's highest prevalence of Hepatitis C virus (HCV). HCV is transmitted through unexamined blood transfusions, different employments of syringes, and poor cleansing, as per the WHO. Our study aimed at screening and management of chronic hepatitis C genotype 4 infected patients in Bardeen village, Sharkeya Governorate, Egypt, with Sofosbuvir plus Daclatasvir, as well as estimating the safety and efficacy of that regimen...
2018: International Journal of Hepatology
https://www.readbyqxmd.com/read/29753369/biosimilars-for-immune-mediated-chronic-diseases-in-primary-care-what-a-practicing-physician-needs-to-know
#5
REVIEW
Steven R Feldman, Jerry Bagel, Shahla Namak
The introduction of biologics has revolutionized the treatment of immune-mediated diseases, but high cost and limited patient access remain hurdles, and some physicians are concerned that biosimilars are not similar enough. The purpose of this narrative review is to describe biosimilar safety, efficacy, nomenclature, extrapolation and interchangeability. In the United States, the Biologics Price Competition and Innovation Act created an abbreviated pathway for licensing of a biologic that is biosimilar to another licensed product (i...
May 2018: American Journal of the Medical Sciences
https://www.readbyqxmd.com/read/29749101/understanding-patient-adherence-and-concerns-with-statins-and-medication-discussions-with-physicians-action-a-survey-on-the-patient-perspective-of-dialogue-with-healthcare-providers-regarding-statin-therapy
#6
Eliot A Brinton
BACKGROUND: Statin therapy is used first-line for cholesterol lowering and prevention of atherosclerotic cardiovascular disease (CVD), but side effects and the potential for drug-drug interactions may complicate its use. Provider-patient communication is essential for shared decision-making, which, in turn, is recommended by guidelines to reduce or overcome these challenges. Unfortunately, relatively little is known about provider-patient communication surrounding statin use. METHOD: We conducted an online survey of 5,014 patients, U...
May 10, 2018: Clinical Cardiology
https://www.readbyqxmd.com/read/29742934/drug-information-association-pharmacovigilance-and-risk-management-strategies-2017-overview-of-the-generic-drug-program-and-surveillance
#7
Howard D Chazin, John R Peters, Debra M Catterson, James L Osterhout, Linda M Forsyth, Jung E Lee, Edward K Kim, Karen B Feibus
The US Food and Drug Administration's (FDA's) generic drug program has dramatically increased the availability of affordable, high quality generic drugs. The foundation of generic drug approvals is a two-tiered regulatory framework of pharmaceutical equivalence and bioequivalence. Intrinsic to both of these is consideration of the clinical relevance of formulation and bioequivalence data to support an inference of therapeutic equivalence, based on clear evidence that there are no significant differences between the generic drug and the brand name drug...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29723372/suppression-of-wheal-and-flare-in-histamine-test-by-the-main-h1-antihistamines-commercialized-in-brazil
#8
Helena Maciel-Guerra, Mariana Álvares Penha, Marília Formentini Scotton Jorge, Ricardo da Silva Libório, Ana Cláudia Nazareno Dos Anjos Carrijo, Maria Rita Parise-Fortes, Hélio Amante Miot
BACKGROUND: Several dermatoses are mediated by histamine, such as urticaria, angioedema, and papular urticaria. There are no Brazilian studies comparing the potency of antihistamines. OBJECTIVES: To evaluate the tolerability and efficacy of the main commercial brand and generic H1 antihistamines, regarding the suppression of the wheal and flare to the histamine test. METHODS: A quasi-experimental, open study with 10 healthy adults submitted to the histamine test on the ventral aspect of the forearms...
March 2018: Anais Brasileiros de Dermatologia
https://www.readbyqxmd.com/read/29717011/statins-suppress-ebola-virus-infectivity-by-interfering-with-glycoprotein-processing
#9
Punya Shrivastava-Ranjan, Mike Flint, Éric Bergeron, Anita K McElroy, Payel Chatterjee, César G Albariño, Stuart T Nichol, Christina F Spiropoulou
Ebola virus (EBOV) infection is a major public health concern due to high fatality rates and limited effective treatments. Statins, widely used cholesterol-lowering drugs, have pleiotropic mechanisms of action and were suggested as potential adjunct therapy for Ebola virus disease (EVD) during the 2013-2016 outbreak in West Africa. Here, we evaluated the antiviral effects of statin (lovastatin) on EBOV infection in vitro Statin treatment decreased infectious EBOV production in primary human monocyte-derived macrophages and in the hepatic cell line Huh7...
May 1, 2018: MBio
https://www.readbyqxmd.com/read/29682298/tenofovir-alafenamide-versus-tenofovir-disoproxil-fumarate-is-there-a-true-difference-in-efficacy-and-safety
#10
EDITORIAL
Andrew Hill, Sophie L Hughes, Dzintars Gotham, Anton L Pozniak
Background: Higher plasma tenofovir concentrations are associated with higher risks of renal and bone adverse events. The pharmacokinetic boosters ritonavir (RTV) and cobicistat (COBI) significantly increase plasma area under the curve (AUC) concentrations of tenofovir disoproxil fumarate (TDF), by 25-37%. When combined with RTV or COBI, the dose of tenofovir alafenamide (TAF) is lowered from 25 mg to 10 mg daily, but the TDF dose is maintained at 300 mg daily. Objective: To assess the differences in safety and efficacy between tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) in regimens with and without the pharmacokinetic boosters RTV and COBI...
April 1, 2018: Journal of Virus Eradication
https://www.readbyqxmd.com/read/29675679/adsorption-and-leachable-contamination-of-flucloxacillin-cyclosporin-and-amiodarone-following-delivery-through-an-intravenous-administration-set
#11
Zachary Woodward, Peter Brooks, Bernadette Morris-Smith, Marianne Wallis, Steven M Ogbourne
PURPOSE: Interactions between a pharmaceutical drug and its delivery device can result in changes in drug concentration and leachable contamination. Flucloxacillin, amiodarone and cyclosporin were investigated for drug concentration changes and leachable contamination after delivery through an intravenous administration set. METHODS: Flucloxacillin, amiodarone and cyclosporin were delivered through an intravenous administration set and the eluate analysed by HPLC-UV and HPLC-MS...
April 19, 2018: Pharmaceutical Research
https://www.readbyqxmd.com/read/29668697/efficacy-and-safety-of-biosimilar-insulins-compared-to-their-reference-products-a-systematic-review
#12
Carolyn Tieu, Eleanor J Lucas, Mindi DePaola, Lori Rosman, G Caleb Alexander
IMPORTANCE: For nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug Administration in 2015, and subsequently Admelog and Lusduna in 2017. OBJECTIVE: To summarize the scientific evidence comparing the safety, efficacy, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products. DATA SOURCES: We conducted a systematic review using PubMed, Cochrane, Embase, Latin America and Caribbean Health Sciences, South Asian Database of Controlled Clinical Trials, and IndiaMED from their inception through January 14, 2018...
2018: PloS One
https://www.readbyqxmd.com/read/29667437/transdermal-buprenorphine-for-moderate-chronic-noncancer-pain-syndromes
#13
Joseph V Pergolizzi, Flaminia Coluzzi, Robert Taylor
Chronic noncancer pain has remained a challenging clinical problem. Opioid analgesics are effective, but they are known to be associated with opioid use disorder and potentially treatment-limiting side effects. Buprenorphine is a Schedule III synthetic opioid in the USA with a chemical structure similar to that of morphine but with a longer duration of action, greater potency, and other unique pharmacological attributes. Its role in treatment of chronic noncancer pain may be broader than currently thought. Areas covered: The pharmacokinetics, pharmacodynamics, clinical efficacy, and safety profile of transdermal buprenorphine in moderate chronic noncancer pain syndromes patients will be discussed...
April 23, 2018: Expert Review of Neurotherapeutics
https://www.readbyqxmd.com/read/29659207/trajectories-of-acute-antidepressant-efficacy-how-long-to-wait-for-response-a-systematic-review-and-meta-analysis-of-long-term-placebo-controlled-acute-treatment-trials
#14
Jonathan Henssler, Mona Kurschus, Jeremy Franklin, Tom Bschor, Christopher Baethge
BACKGROUND: In patients who are not responding to antidepressant pharmacotherapy, information regarding the future probability of response with the same treatment is scarce. Specifically, it is unclear at what point in time the probability to respond or remit ceases to increase, because few studies report data on response or remission at repeated time points beyond 4 or 8 weeks of treatment. Consequently, treatment recommendations in clinical practice guidelines differ widely. DATA SOURCES: We systematically searched MEDLINE, Embase, PsycINFO, and CENTRAL databases through March 2014 using generic terms for depressive or affective disorders, individual drug names, and placebo (Prospero Registration: CRD42014010105)...
April 3, 2018: Journal of Clinical Psychiatry
https://www.readbyqxmd.com/read/29652301/-the-results-of-an-open-comparative-retrospective-trial-of-the-course-of-multiple-sclerosis-during-treatment-with-infibeta-and-other-interferon-beta-bioanalogues-and-glatiramer-acetate
#15
F A Khabirov, T I Khaybullin, E V Granatov, S R Shakirzianova, N N Babicheva, O S Kochergina, E F Rakhmatullina, G M Akhmedova, L A Averyanova, M A Yakupov, Zh F Sabirov
AIM: To evaluate the efficacy and safety of the interferon beta-1b bioanalogue 'infibeta' in the treatment of multiple sclerosis (MS) in comparison with other interferon beta bioanalogues and the generic drug glatiramer acetate. MATERIAL AND METHODS: The data of 500 patients with MS treated with different disease-modifying drugs were analyzed. Patients of group 1 (n=95) received infibeta; group 2 (n=108) interferon beta-1b; group 3 (n=83) genfaxon-44; group 4 (n=109) sinnovex; group 5 (n=105) aksoglatiran FS...
2018: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
https://www.readbyqxmd.com/read/29599970/medication-practice-in-hospitals-are-nanosimilars-evaluated-and-substituted-correctly
#16
Josefien Knoeff, Beat Flühmann, Stefan Mühlebach
Introduction: This study investigates the drug selection and dispensing behaviour of hospital pharmacists of intravenous iron products including iron sucrose and iron sucrose similar, with special emphasis on substitution and interchangeability in France and Spain. Iron-carbohydrate complex drugs represent different available intravenous iron drugs and are part of the non-biological complex drug (NBCD) class, an expanding drug class with up to 30 brands available in intravenous pharmacotherapy and over 50 in clinical development...
March 2018: European Journal of Hospital Pharmacy. Science and Practice
https://www.readbyqxmd.com/read/29582618/comparison-of-clinical-effects-trough-and-peak-levels-between-branded-and-generic-formulation-of-cyclosporine-in-stable-psoriatic-patients
#17
Cinzia Buligan, Caterina Pinzani, Rossella Cimarosti, Giuseppe Stinco, Massimo Baraldo
BACKGROUND: Cyclosporine A (CyA) is a drug for moderate-to-severe psoriasis. Recently, a generic formulation has been approved as bioequivalent to the branded one. The guidelines for the bioequivalence for critical-dose drugs with a narrow therapeutic range, such as CyA, are questionable. Therefore, it is important to assess the clinical outcome and the pharmacokinetics of different formulations in various patient groups. The current literature lacks of this information in dermatology...
March 26, 2018: Giornale Italiano di Dermatologia e Venereologia: Organo Ufficiale, Società Italiana di Dermatologia e Sifilografia
https://www.readbyqxmd.com/read/29568713/translating-new-science-into-the-drug-review-process-the-us-fda-s-division-of-applied-regulatory-science
#18
Rodney Rouse, Naomi Kruhlak, James Weaver, Keith Burkhart, Vikram Patel, David G Strauss
In 2011, the US Food and drug Administration (FDA) developed a strategic plan for regulatory science that focuses on developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. In line with this, the Division of Applied Regulatory Science was created to move new science into the Center for Drug Evaluation and Research (CDER) review process and close the gap between scientific innovation and drug review. The Division, located in the Office of Clinical Pharmacology, is unique in that it performs mission-critical applied research and review across the translational research spectrum including in vitro and in vivo laboratory research, in silico computational modeling and informatics, and integrated clinical research covering clinical pharmacology, experimental medicine, and postmarket analyses...
March 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29567088/community-pharmacists-understanding-and-perceptions-of-fda-therapeutic-equivalence-standards
#19
Brandon J Euen, Hala M Fadda
BACKGROUND: Pharmacists need to demonstrate knowledge of and have confidence in Food and Drug Administration (FDA) therapeutic equivalence (TE) standards to improve acceptance of generic medicines amongst patients and other healthcare professionals. OBJECTIVE: To evaluate community pharmacists' understanding, interpretation and perceptions of the FDA TE standards to identify if further education is needed on this topic. METHODS: An anonymous, 13-item survey was piloted and then distributed by e-mail to a random sample of 287 Indiana community pharmacists...
March 7, 2018: Research in Social & Administrative Pharmacy: RSAP
https://www.readbyqxmd.com/read/29557685/magnesium-sulfate-and-calcium-channel-blocking-drugs-as-antidotes-for-acute-organophosphorus-insecticide-poisoning-a-systematic-review-and-meta-analysis
#20
Miran Brvar, Ming Yin Chan, Andrew H Dawson, Richard R Ribchester, Michael Eddleston
INTRODUCTION: Treatment of acute organophosphorus or carbamate insecticide self-poisoning is often ineffective, with tens of thousands of deaths occurring every year. Researchers have recommended the addition of magnesium sulfate or calcium channel blocking drugs to standard care to reduce acetylcholine release at cholinergic synapses. OBJECTIVE: We aimed to review systematically the evidence from preclinical studies in animals exposed to organophosphorus or carbamate insecticides concerning the efficacy of magnesium sulfate and calcium channel blocking drugs as therapy compared with placebo in reducing mortality or clinical features of poisoning...
March 20, 2018: Clinical Toxicology
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