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Efficacy of generic drugs

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https://www.readbyqxmd.com/read/29667437/transdermal-buprenorphine-for-moderate-chronic-noncancer-pain-syndromes
#1
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 18, 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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
https://www.readbyqxmd.com/read/29557204/next-generation-fixed-dose-combination-pharmacotherapies-for-treating-hiv
#9
Margaret R Caplan, Eric S Daar, Katya C Corado
Treatment options for patients with HIV-1 infection have grown over the past two decades to include multiple fixed-dose combination pharmacotherapies that have greatly simplified administration of antiretroviral therapy (ART) for both patients and providers. Effective virologic control can often be achieved with once-daily use of a single-tablet regimen. Over the past three years, ART drug development has focused on the next generation of fixed-dose combinations for initial and maintenance therapy with improved efficacy, safety and tolerability...
March 20, 2018: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29555162/-the-use-of-generics-in-transplantation-towards-rational-and-safe-solutions
#10
Jacques Rottembourg, Guy Rostoker
Generic immunosuppressive drugs are available in Europe Canada and the United States. Between countries, there are large differences in penetration of generic drugs in general, and for immunosuppressive drugs in particular. The registration for generic immunosuppressive drugs are slightly different, but the criteria for registration of narrow therapeutic index drugs and bioequivalence studies, performed only in healthy volunteers, will remain in the medical landscape. About 50 studies compare the clinical efficacy and bioequivalence of the generic immunosuppressive drugs in patients with solid organ transplants...
March 16, 2018: La Presse Médicale
https://www.readbyqxmd.com/read/29527129/a-critical-appraisal-on-ait-in-childhood-asthma
#11
REVIEW
Matteo Ferrando, Francesca Racca, Lorena Nascimento Girardi Madeira, Enrico Heffler, Giovanni Passalacqua, Francesca Puggioni, Niccolò Stomeo, Giorgio Walter Canonica
Abstract: Allergen immunotherapy (AIT) is the only disease-modifying treatment approved for allergic rhinitis and allergic asthma and represents a suitable therapeutic option, especially in childhood, to modify the progression of respiratory allergic diseases. Starting from the previous "generic class effect" evaluation, as testified by the numerous meta analyses, AIT is now considered a product-specific pathogenic-oriented treatment. Background: AIT was empirically proposed more than one century ago in the subcutaneous form (SCIT), but the IgE-mediated mechanism of allergy was elucidated only after 50 years of clinical use of the treatment...
2018: Clinical and Molecular Allergy: CMA
https://www.readbyqxmd.com/read/29483770/comparison-of-the-long-term-efficacy-and-safety-of-generic-tacrolimus-tacrobell-with-prograf-in-liver-transplant-recipients
#12
Ho Joong Choi, Dong Goo Kim, Bong Jun Kwak, Jae Hyun Han, Tae Ho Hong, Young Kyoung You
Introduction: The purpose of this study was to compare the safety and efficacy of generic tacrolimus (Tacrobell [TCB]) and a reference tacrolimus (Prograf [PGF]) in liver transplant recipients. Patients and methods: We retrospectively analyzed 167 patients who used TCB or PGF between January 2009 and March 2016 for >1 year (TCB group, n=86; PGF group, n=81). To assess the efficacy and safety of TCB, we evaluated the relationship between drug dose and trough level, survival, rejection, infection, kidney function, and side effects...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29476937/biosimilar-switching-and-related-medical-liability
#13
Paolo Rocco, Sonia Selletti, Paola Minghetti
Unlike generics, biosimilars are similar, but not equivalent, to the reference biological medicinal product. Therefore, if a patient experiences an adverse event, or a loss of efficacy, when transitioned to a biosimilar, the distribution of medical liability will be different from the case of both the originator and generics. Moreover, the case of naïve patients is different from that of non-naïve patients. In the case of naïve patients, physicians make their choice from a range of medicinal products that pose the same risk, since it is not possible to know with any certainty the patients' response to each therapeutic option until they have taken the drug...
February 17, 2018: Journal of Forensic and Legal Medicine
https://www.readbyqxmd.com/read/29466056/a-guide-to-follow-on-biologics-and-biosimilars-with-a-focus-on-insulin
#14
Richard Dolinar, Frank Lavernia, Steven Edelman
OBJECTIVE: Many healthcare providers in the U.S. are not familiar with follow-on biologics and biosimilars nor with their critical distinctions from standard generics. Our aim is to provide a detailed review of both, with a focus on insulins in the U.S. regulatory system. METHODS: Literature has been reviewed to provide information on various aspects of biosimilars and a follow-on biologic of insulin. This will include structure, efficacy, cost, switching, and legal issues...
February 2018: Endocrine Practice
https://www.readbyqxmd.com/read/29383440/-revised-version-of-the-statement-by-the-dgrh-on-biosimilars-update-2017
#15
J Braun, H M Lorenz, U Müller-Ladner, M Schneider, H Schulze-Koops, Ch Specker, A Strangfeld, U Wagner, T Dörner
The treatment of rheumatic diseases with bioloics has significantly improved the prognosis of patients. Currently, there are 13 preparations available in Germany for the treatment of patients with inflammatory rheumatic diseases. These original preparations generally have-depending on the individual country-15 years of patent protection. As soon as the patent has expired, approved biosimilars can be brought into use. For the approval of a biosimilar, authorities such as the European Medical Agency or the American Food and Drug Administration require proof of the best possible comparability with respect to efficacy and safety in comparison to the original or reference product...
January 30, 2018: Zeitschrift Für Rheumatologie
https://www.readbyqxmd.com/read/29380058/patients-and-hematologists-concerns-regarding-tyrosine-kinase-inhibitor-therapy-in-chronic-myeloid-leukemia
#16
Qian Jiang, Lu Yu, Robert Peter Gale
PURPOSE: To explore patients' and hematologists' concerns regarding tyrosine kinaseinhibitor (TKI)-therapy and identify variables associated these concerns. Methods A cross-sectional questionnaire including 16 common issues related to TKI-therapy was distributed to adults with chronic myeloid leukemia (CML) receiving TKIs and hematologists treating CML patients and answered anonymously. RESULTS: Data from 1518 patient respondents receiving TKI-therapy ≥ 3 months were analyzed...
January 29, 2018: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/29379674/clinical-tolerability-of-generic-versus-brand-beta-blockers-in-heart-failure-with-reduced-left-ventricular-ejection-fraction-a-retrospective-cohort-from-heart-failure-clinic
#17
Rattanachai Chanchai, Rungsrit Kanjanavanit, Krit Leemasawat, Anong Amarittakomol, Paleerat Topaiboon, Arintaya Phrommintikul
Background: Beta-blockers have been shown to decrease mortality and morbidity in heart failure with reduced ejection fraction (HFrEF) patients. However, the side effects are also dose-related, leading to the underdosing. Cost constraint may be one of the limitations of appropriate beta-blocker use; this can be improved with generic drugs. However, the effects in real life practice have not been investigated. Methods and results: This study aimed to compare the efficacy and safety of generic and brand beta-blockers in HFrEF patients...
2018: Journal of Drug Assessment
https://www.readbyqxmd.com/read/29359677/comparative-randomized-crossover-clinical-study-for-the-evaluation-of-erectile-dysfunction-medications-via-novel-pentagon-system-113-characters
#18
Mohamed Ismail Nounou, Ghada ElHaddad, Fatema ElAmrawy, Ola ElGaddar, Ahmed ElYazbi, Ahmed Eshra
INTRODUCTION: Due to the chaos in the legislation in the Middle East, male enhancement nutraceuticals may be sold without any registration or evaluation. These products need be evaluated with respect to safety and efficacy. Furthermore, cultural and social considerations in the Middle East prevent the use of international evaluations schemes for erectile dysfunction. AIM: Evaluating the safety and efficacy parameters of generic and nutraceutical products for erectile dysfunction in the Middle East through a custom-designed, representable and simple system tailored to the regional culture...
January 22, 2018: Current Drug Safety
https://www.readbyqxmd.com/read/29331750/phosphoinositide-3-kinase-inhibitors-in-advanced-breast-cancer-a-systematic-review-and-meta-analysis
#19
REVIEW
Jacques Raphael, Danielle Desautels, Kathleen I Pritchard, Ekaterina Petkova, Prakeshkumar S Shah
Phosphoinositide 3-kinase (PI3K) inhibitors may overcome drug resistance and improve advanced breast cancer (ABC) outcomes. We conducted a systematic review and meta-analysis to assess the efficacy and safety of adding a PI3K inhibitor to the standard of care (SOC) treatment in ABC. The electronic databases Ovid, PubMed, Cochrane Central Register of Controlled Trials and Embase, were searched for relevant randomised trials. Pooled hazard ratios (HRs) for progression-free survival (PFS) and pooled risk ratios (RRs) for objective response rates (ORRs), disease control rates (DCRs) and toxicity were meta-analysed using the Mantel-Haenszel method and generic inverse variance...
March 2018: European Journal of Cancer
https://www.readbyqxmd.com/read/29327520/risk-factors-of-clinical-and-immunological-failure-in-south-indian-cohort-on-generic-antiretroviral-therapy
#20
Mucheli Shravan Sadashiv, Priscilla Rupali, Abi Manesh, Rajesh Kannangai, Ooriapadickal Cherian Abraham, Susanne A Pulimood, Rajiv Karthik, S Rajkumar, Kurien Thomas
Background: Since the time of NACO Antiretroviral (ART) roll-out, generic ART has been the mainstay of therapy. There are many studies documenting the efficacy of generic ART but with the passage of time, failure of therapy is on the rise. As institution of second line ART has significant financial implications both for a program and for an individual it is imperative that we determine factors which contribute towards treatment failure in a cohort of patients on generic antiretroviral therapy...
December 2017: Journal of the Association of Physicians of India
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