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Efficacy of generic drugs

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https://www.readbyqxmd.com/read/29466056/a-guide-to-follow-on-biologics-and-biosimilars-with-a-focus-on-insulin
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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...
January 10, 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
#7
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
https://www.readbyqxmd.com/read/29322918/a-linear-programming-computational-framework-integrates-phosphor-proteomics-and-prior-knowledge-to-predict-drug-efficacy
#8
Zhiwei Ji, Bing Wang, Ke Yan, Ligang Dong, Guanmin Meng, Lei Shi
BACKGROUND: In recent years, the integration of 'omics' technologies, high performance computation, and mathematical modeling of biological processes marks that the systems biology has started to fundamentally impact the way of approaching drug discovery. The LINCS public data warehouse provides detailed information about cell responses with various genetic and environmental stressors. It can be greatly helpful in developing new drugs and therapeutics, as well as improving the situations of lacking effective drugs, drug resistance and relapse in cancer therapies, etc...
December 21, 2017: BMC Systems Biology
https://www.readbyqxmd.com/read/29317432/in-silico-evaluation-of-pharmacokinetic-optimization-for-antimitogram-based-clinical-trials
#9
Skerdi Haviari, Benoît You, Michel Tod
Antimitograms are prototype in vitro tests for evaluating chemotherapeutic efficacy using patient-derived primary cancer cells. These tests might help optimize treatment from a pharmacodynamic (PD) standpoint by guiding treatment selection. However, they are technically challenging and require refinements and trials to demonstrate benefit in order to be widely used. In this study, we performed simulations aimed at exploring how to validate antimitograms and how to complement them by pharmacokinetic (PK) optimization...
January 9, 2018: Cancer Research
https://www.readbyqxmd.com/read/29300350/exploring-the-knowledge-and-perception-of-generic-medicines-among-final-year-undergraduate-medical-pharmacy-and-nursing-students-in-sierra-leone-a-comparative-cross-sectional-approach
#10
Peter Bai James, Abdulai Jawo Bah, Emmanuel Kamanda Margao, Christian Hanson, John Alimamy Kabba, Shazia Qasim Jamshed
Most low-income nations have national medicine policy that emphasized the use of generic medicines in the public health sector. However, the use of generics is often debatable as there are concerns over its efficacy, quality, and safety compared to their branded counterparts. This study was conducted to compare the knowledge and perception of generic medicines among final year undergraduate medical, pharmacy, and nursing students in Sierra Leone. We conducted a questionnaire-based cross-sectional study among these students at the College of Medicine and Allied Health Sciences University of Sierra Leone...
January 4, 2018: Pharmacy (Basel, Switzerland)
https://www.readbyqxmd.com/read/29290412/-prospective-study-of-the-factors-associated-with-the-acceptance-of-generics-substitution-by-patients-and-their-liberal-doctors
#11
S Iskounen, G Simoneau, S Mouly
BACKGROUND: Many prescribers and patients remain reluctant to substitution to generics. METHODS: We conducted a prospective observational study, using semi-structured interviews adapted to identify factors independently associated with the acceptance of alternative to a generic drug by doctors and patients. RESULTS: Between December 2014 and August 2015, 108 patients and 73 private doctors from Île-de-France and Nord-Pas-de-Calais were enrolled...
December 28, 2017: La Revue de Médecine Interne
https://www.readbyqxmd.com/read/29273011/time-course-study-of-the-response-to-lps-targeting-the-pig-immune-gene-networks
#12
Elena Terenina, Valérie Sautron, Caroline Ydier, Darya Bazovkina, Amélie Sevin-Pujol, Laure Gress, Yannick Lippi, Claire Naylies, Yvon Billon, Laurence Liaubet, Pierre Mormede, Nathalie Villa-Vialaneix
BACKGROUND: Stress is a generic term used to describe non-specific responses of the body to all kinds of challenges. A very large variability in the response can be observed across individuals, depending on numerous conditioning factors like genetics, early influences and life history. As a result, there is a wide range of individual vulnerability and resilience to stress, also called robustness. The importance of robustness-related traits in breeding strategies is increasing progressively towards the production of animals with a high level of production under a wide range of climatic conditions and management systems, together with a lower environmental impact and a high level of animal welfare...
December 22, 2017: BMC Genomics
https://www.readbyqxmd.com/read/29244729/comparative-evaluation-of-u-s-brand-and-generic-intravenous-sodium-ferric-gluconate-complex-in-sucrose-injection-in-vitro-cellular-uptake
#13
Min Wu, Dajun Sun, Katherine Tyner, Wenlei Jiang, Rodney Rouse
Iron deficiency anemia is a common clinical consequence for people who suffer from chronic kidney disease, especially those requiring dialysis. Intravenous (IV) iron therapy is a widely accepted safe and efficacious treatment for iron deficiency anemia. Numerous IV iron drugs have been approved by U.S. Food and Drug Administration (FDA), including a single generic product, sodium ferric gluconate complex in sucrose. In this study, we compared the cellular iron uptake profiles of the brand (Ferrlecit®) and generic sodium ferric gluconate (SFG) products...
December 15, 2017: Nanomaterials
https://www.readbyqxmd.com/read/29238196/the-role-of-new-antidepressants-in-clinical-practice-in-canada-a-brief-review-of-vortioxetine-levomilnacipran-er-and-vilazodone
#14
REVIEW
Roger S McIntyre
Although many branded and generic antidepressants are approved for the treatment of major depressive disorder (MDD) in Canada, efficacy and tolerability differ among patients, and new treatment options are needed. Symptom types (eg, fatigue, energy/motivation, cognition, and functioning), medication type, treatment duration, and the need for maintenance therapy are factors that may influence treatment effectiveness. Three antidepressants, vortioxetine, levomilnacipran extended-release (ER), and vilazodone have recently become available in Canada...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/29226862/the-rationale-and-design-of-the-reducing-pathology-in-alzheimer-s-disease-through-angiotensin-targeting-radar-trial
#15
Patrick G Kehoe, Peter S Blair, Beth Howden, David L Thomas, Ian B Malone, Jeremy Horwood, Clare Clement, Lucy E Selman, Hannah Baber, Athene Lane, Elizabeth Coulthard, Anthony Peter Passmore, Nick C Fox, Ian B Wilkinson, Yoav Ben-Shlomo
BACKGROUND: Anti-hypertensives that modify the renin angiotensin system may reduce Alzheimer's disease (AD) pathology and reduce the rate of disease progression. OBJECTIVE: To conduct a phase II, two arm, double-blind, placebo-controlled, randomized trial of losartan to test the efficacy of Reducing pathology in Alzheimer's Disease through Angiotensin TaRgeting (RADAR). METHODS: Men and women aged at least 55 years with mild-to-moderate AD will be randomly allocated 100 mg encapsulated generic losartan or placebo once daily for 12 months after successful completion of a 2-week open-label phase and 2-week placebo washout to establish drug tolerability...
2018: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/29214495/comparison-of-anti-influenza-virus-activity-and-pharmacokinetics-of-oseltamivir-free-base-and-oseltamivir-phosphate
#16
Jin Soo Shin, Keun Bon Ku, Yejin Jang, Yi-Seul Yoon, Daeho Shin, Oh Seung Kwon, Yun Young Go, Seong Soon Kim, Myoung Ae Bae, Meehyein Kim
Influenza viruses are major human respiratory pathogens that cause high morbidity and mortality worldwide. Currently, prophylactic vaccines and therapeutic antiviral agents are used to prevent and control influenza virus infection. Oseltamivir free base (OSV-FB), a modified generic antiviral drug of Tamiflu (oseltamivir phosphate, OSV-P), was launched in the Republic of Korea last year. Here, we examine the bioequivalence of these two compounds by assessing their antiviral efficacy in infected cells and in a mouse model...
December 2017: Journal of Microbiology / the Microbiological Society of Korea
https://www.readbyqxmd.com/read/29210777/costs-and-benefits-of-on-demand-hiv-preexposure-prophylaxis-in-msm
#17
Isabelle Durand-Zaleski, Pierre Mutuon, Isabelle Charreau, Cecile Tremblay, Daniela Rojas, Gilles Pialoux, Christian Chidiac, Catherine Capitant, Bruno Spire, Laurent Cotte, Julie Chas, Laurence Meyer, Jean Michel Molina
OBJECTIVES: We undertook the economic evaluation of the double-blind randomized ANRS-IPERGAY trial, which showed the efficacy of on-demand preexposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) in preventing HIV infection among high-risk MSM. DESIGN AND METHODS: The economic evaluation was prospective. Counseling, drugs (TDF-FTC at &OV0556;500.88 for 30 tablets), tests, visits, and hospital admissions were valued based on in-trial use...
January 2, 2018: AIDS
https://www.readbyqxmd.com/read/29189133/risk-assessment-and-monitoring-of-antibody-responses-to-biosimilars-in-chronic-inflammatory-diseases
#18
Iris Detrez, Ann Gils
BACKGROUND: The expiry of the patent of several leading biological medicinal products has led to a surge in the development of 'biosimilar' products. In contrast to generic small-molecule medicines, biosimilars are not identical to their reference medicinal products. METHODS: Full comparability in quality as well as in preclinical and clinical issues is required to register a biosimilar. Since immunogenicity is key for biological medicinal products, regulatory authorities in the European Union require antidrug antibody (ADA) responses to be evaluated and to be approached from a safety perspective...
November 29, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/29173186/comparison-of-physicochemical-properties-of-generic-doxorubicin-hcl-liposome-injection-with-the-reference-listed-drug
#19
Subhas Bhowmick, Kuntal Maiti, Pankaj Jain, Murlidhar Zope, Keyur Doshi, Thennati Rajamannar
BACKGROUND: Liposomal doxorubicin is widely used for treating ovarian cancer and Kaposi's sarcoma. Encapsulation of doxorubicin in highly complex polyethylene glycol-coated (stealth) liposomes prolongs residence time and avoids the systemic toxicity associated with administration of the free drug. Small variations in physicochemical properties introduced during manufacture of liposomes can influence the payload of encapsulated drug, stability of liposomes under physiological conditions, and release of drug at the target tissue...
November 21, 2017: Anti-cancer Agents in Medicinal Chemistry
https://www.readbyqxmd.com/read/29171502/-memantine-from-the-original-brand-to-generics
#20
N V Titova
Memantine is the first clinically available glutamate antagonist, with an antagonist action at the N-methyl-D-aspartate receptors in the brain, for correction of cognitive and behavioral functions in neurodegenerative disorders. Glutamate mediated excitotoxic neuronal damage has been implicated in Alzheimer's disease (AD) and other parkinsonism-related dementias and, therefore, memantine represents a novel mode of action to counteract the glutamate-mediated excitotoxicity. In moderate to severe AD, 20 mg of memantine shows a positive effect on cognition, mood, behavior and the ability to perform activities of daily living...
2017: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
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