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Efficacy of generic drugs

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https://www.readbyqxmd.com/read/29214495/comparison-of-anti-influenza-virus-activity-and-pharmacokinetics-of-oseltamivir-free-base-and-oseltamivir-phosphate
#1
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
#2
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
#3
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
#4
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
#5
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
https://www.readbyqxmd.com/read/29154834/development-and-characterization-of-docetaxel-loaded-lecithin-stabilized-micellar-drug-delivery-system-lsbmdds-for-improving-the-therapeutic-efficacy-and-reducing-systemic-toxicity
#6
Chia-Yu Su, Jun-Jen Liu, Yuan-Soon Ho, Yi-You Huang, Vincent Hung-Shu Chang, Der-Zen Liu, Ling-Chun Chen, Hsiu-O Ho, Ming-Thau Sheu
In the present study, we attempted to develop a lecithin-stabilized micellar drug delivery system (LsbMDDs) for loading docetaxel (DTX) to enhance its therapeutic efficacy and minimize systemic toxicity. A novel DTX-loaded LsbMDDs was optimally prepared by a thin-film hydration method and then hydrated with a lecithin nanosuspension while being subjected to ultrasonication. Physical characteristics of the optimized DTX-loaded LsbMDDs formulations were examined and found to have a mean size of <200 nm, an encapsulation efficiency of >90%, and drug loading of >6% with stability at room temperature and at 4° C being longer than 2 and 7 days, respectively...
November 14, 2017: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29149162/-switching-from-one-drug-therapy-to-another-with-the-same-therapeutic-indication-without-harms
#7
Valeria Belleudi, Antonio Addis
The loss of exclusivity from several drug therapies largely used bring new attention the issues of safety, efficacy and following the switch from one drug to another (i.e., biosimilar and/or generics) with the same indication. This is not a problem that can be related to regulatory or economical factors. The increase of patients exposed to chronic conditions and the introductions or more pharmaceutical alternatives with same therapeutic indications yield for studies able to verify the effectiveness and safety even when switch from more drugs is considered by practitioners...
November 2017: Recenti Progressi in Medicina
https://www.readbyqxmd.com/read/29149148/current-impact-and-application-of-abuse-deterrent-opioid-formulations-in-clinical-practice
#8
Ya-Han Lee, Daniel L Brown, Hsiang-Yin Chen
BACKGROUND: Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse. OBJECTIVE: We aim to compare and contrast the characteristics and applications of current abuse-deterrent opioid products in clinical practice. METHODS: Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations...
November 2017: Pain Physician
https://www.readbyqxmd.com/read/29139187/pharmacokinetics-and-safety-of-paclitaxel-delivery-into-porcine-airway-walls-by-a-new-endobronchial-drug-delivery-catheter
#9
Hisashi Tsukada, Plamena Entcheva-Dimitrov, Armin Ernst, Samaan Rafeq, John H Keating, Kirk P Seward, Lonny Yarmus
BACKGROUND AND OBJECTIVE: Intratumoral administration of chemotherapeutic agents is a treatment modality that has proven efficacious in reducing the recurrence of tumours and increases specificity of treatment while minimizing systemic side effects. Direct intratumoral injection of malignant airway obstruction has potential therapeutic benefits but tissue drug concentrations and side-effect profiles are poorly understood. METHODS: Bronchial wall injection of generic paclitaxel (PTX) (102 injections of 0...
November 14, 2017: Respirology: Official Journal of the Asian Pacific Society of Respirology
https://www.readbyqxmd.com/read/29121918/-no-generics-doctor-the-perspective-of-general-practitioners-in-two-french-regions
#10
Béatrice Riner, Adèle Bussy, Jeannie Hélène-Pelage, Nycrees Moueza, Sébastien Lamy, Philippe Carrère
BACKGROUND: Generic medicines are essential to controlling health expenditures. Their market share is still small in France. The discourse and practices of prescribers may play a major role in their use. The purpose of this study was to explore the knowledge, attitudes and practices of general practitioners (GPs) toward generic medicines in two French regions with the lowest penetration rate of these products. METHODS: An observational study was carried out from October 2015 to February 2016 in Guadeloupe and Martinique...
November 9, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/29114561/awareness-about-rational-use-of-medicines-among-fresh-bachelor-of-medicine-and-bachelor-of-surgery-graduates
#11
Vijaya Laxman Chaudhari, Smita N Mali, Amruta V Dawari, Tushar B Nishandar
CONTEXT: Fresh Bachelor of Medicine and Bachelor of Surgery graduates (FMGs) are responsible for the majority of prescription errors and irrational use of medicines. Little research has explored their knowledge on rational prescribing practices. AIMS: The present study aimed to evaluate the awareness of rational use of medicines (RUMs) among the FMGs. SETTINGS AND DESIGN: A multicentric, cross-sectional, and questionnaire-based study was conducted among 308 FMGs during the internship orientation program...
2017: Journal of Education and Health Promotion
https://www.readbyqxmd.com/read/29103339/lesinurad-for-the-treatment-of-hyperuricaemia-in-people-with-gout
#12
Philip C Robinson, Nicola Dalbeth
Gout is a common form of inflammatory arthritis caused by deposition of monosodium urate crystals. The central strategy for effective long-term management of gout is serum urate lowering. Current urate-lowering drugs include both xanthine oxidase inhibitors and uricosuric agents. Lesinurad is a URAT1 inhibitor that selectively inhibits urate rebsorption at the proximal renal tubule. Lesinurad 200mg daily in combination with a xanthine oxidase is approved for urate-lowering therapy in patients with gout. Areas covered: The published literature was searched using Pubmed and additional information was obtained from publically available regulatory documents...
November 13, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29073981/applying-multi-criteria-decision-analysis-mcda-simple-scoring-as-an-evidence-based-hta-methodology-for-evaluating-off-patent-pharmaceuticals-opps-in-emerging-markets
#13
Diana Brixner, Nikos Maniadakis, Zoltán Kaló, Shanlian Hu, Jie Shen, Kalman Wijaya
Off-patent pharmaceuticals (OPPs) represent more than 60% of the pharmaceutical market in many emerging countries, where they are frequently evaluated primarily on cost rather than with health technology assessment. OPPs are assumed to be identical to the originators. Branded and unbranded generic versions can, however, vary from the originator in active pharmaceutical ingredients, dosage, consistency formulation, excipients, manufacturing processes, and distribution, for example. These variables can alter the efficacy and safety of the product, negatively impacting both the anticipated cost savings and the population's health...
September 2017: Value in Health Regional Issues
https://www.readbyqxmd.com/read/29057664/the-8th-annual-symposium-on-clinical-pharmaceutical-solutions-through-analysis-clinical-and-pharmaceutical-success-from-discovery-to-regulatory-approval-biomarkers-modeling-and-analytical-technologies
#14
Tianyi Tee Zhang, Naidong Weng, Mike Lee
Renaissance Shanghai Pudong Hotel, Shanghai, China, 12-14 April 2017 The 8th Annual Shanghai Symposium on Clinical and Pharmaceutical Solutions through Analysis (CPSA): Clinical and Pharmaceutical Success from Discovery to Regulatory Approval: Biomarkers, Modeling and Analytical Technologies (CPSA Shanghai 2017) was held on 12-14 April 2017 in Shanghai, China. The meeting was featured with highly interactive events including diversified symposia, workshops, roundtable discussions, conference awards and poster sessions...
October 21, 2017: Bioanalysis
https://www.readbyqxmd.com/read/29057082/high-sustained-virological-response-rates-using-imported-generic-direct-acting-antiviral-treatment-for-hepatitis-c
#15
EDITORIAL
Andrew Hill, Giten Khwairakpam, James Wang, Sergey Golovin, Julia Dragunova, Rachel Smith, Vicky Houghton-Price, Roxanna Korologou-Linden, Sanjay Nath, Anna Savage, Greg Jefferys
BACKGROUND: High prices of direct acting antivirals (DAAs) for hepatitis C virus (HCV) can lead to restrictions on access to treatment in high- and middle-income countries. An increasing number of people in these countries are treating their HCV infection with generic drugs produced in India, China, Bangladesh or Egypt. This analysis assessed the efficacy of generic imported DAAs. METHODS: Patients sourced generic versions of sofosbuvir (SOF), ledipasvir (LDV) and daclatasvir (DCV) from suppliers in India, Bangladesh, China and Egypt via three buyers' clubs...
October 1, 2017: Journal of Virus Eradication
https://www.readbyqxmd.com/read/29044101/controlling-the-bioactivity-of-a-peptide-hormone-in-vivo-by-reversible-self-assembly
#16
Myriam M Ouberai, Ana L Gomes Dos Santos, Sonja Kinna, Shimona Madalli, David C Hornigold, David Baker, Jacqueline Naylor, Laura Sheldrake, Dominic J Corkill, John Hood, Paolo Vicini, Shahid Uddin, Steven Bishop, Paul G Varley, Mark E Welland
The use of peptides as therapeutic agents is undergoing a renaissance with the expectation of new drugs with enhanced levels of efficacy and safety. Their clinical potential will be only fully realised once their physicochemical and pharmacokinetic properties have been precisely controlled. Here we demonstrate a reversible peptide self-assembly strategy to control and prolong the bioactivity of a native peptide hormone in vivo. We show that oxyntomodulin, a peptide with potential to treat obesity and diabetes, self-assembles into a stable nanofibril formulation which subsequently dissociates to release active peptide and produces a pharmacological effect in vivo...
October 18, 2017: Nature Communications
https://www.readbyqxmd.com/read/29033595/drug-tendering-drug-supply-and-shortage-implications-for-the-uptake-of-biosimilars
#17
REVIEW
George Dranitsaris, Ira Jacobs, Carol Kirchhoff, Robert Popovian, Lesley G Shane
Due to the continued increase in global spending on health care, payers have introduced a number of programs, policies, and agreements on pharmaceutical pricing in order to control costs. While incentives to increase generic drug use have achieved significant savings, other cost-containment measures are required. Tendering is a formal procedure to purchase medications using competitive bidding for a particular contract. Although useful for cost containment, tendering can lead to decreased competition in a given market...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/29028656/costs-and-benefits-of-on-demand-hiv-pre-exposure-prophylaxis-in-men-who-have-sex-with-men-analysis-of-the-anrs-ipergay-study-with-a-one-year-follow-up
#18
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
OBJECTIVES: We undertook the economic evaluation of the double-blind randomized ANRS-IPERGAY trial which showed the efficacy of on-demand pre-exposure prophylaxis (PrEP) with tenofovir-disoproxil-fumarate (TDF-FTC) in preventing HIV infection among high risk men-who have-sex-with-men (MSM). DESIGN & 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...
October 12, 2017: AIDS
https://www.readbyqxmd.com/read/29027212/complexity-of-intravenous-iron-nanoparticle-formulations-implications-for-bioequivalence-evaluation
#19
REVIEW
Amy Barton Pai
Intravenous iron formulations are a class of complex drugs that are commonly used to treat a wide variety of disease states associated with iron deficiency and anemia. Venofer® (iron-sucrose) is one of the most frequently used formulations, with more than 90% of dialysis patients in the United States receiving this formulation. Emerging data from global markets outside the United States, where many iron-sucrose similars or copies are available, have shown that these formulations may have safety and efficacy profiles that differ from the reference listed drug...
October 13, 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/28993541/psychiatrists-attitude-and-use-of-second-generation-antipsychotics-for-the-treatment-of-schizophrenia-in-taiwan
#20
C K Chen, H H Su, I W Sun
OBJECTIVES: This survey aimed to understand the attitude of psychiatrists and their use of commonly prescribed second-generation antipsychotics (SGAs) for the treatment of schizophrenia in Taiwan. It also attempted to identify the factors that might influence their preference for selecting SGAs. METHODS: Psychiatrists were interviewed face-to-face using a structured questionnaire. The questionnaire addressed various issues involved in the treatment of patients with schizophrenia, including the reasons for selecting SGAs, psychiatrists' level of satisfaction with commonly prescribed SGAs, and their current use of SGAs in clinical practice...
September 2017: East Asian Archives of Psychiatry: Official Journal of the Hong Kong College of Psychiatrists
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