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Efficacy of generic drugs

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https://www.readbyqxmd.com/read/28627427/144-week-efficacy-and-safety-of-a-once-daily-single-tablet-regimen-of-tenofovir-lamivudine-and-efavirenz-among-arv-na%C3%A3-ve-and-arv-experienced-hiv-1-infected-thai-adults
#1
Anchalee Avihingsanon, Wirach Maek-A-Nantawat, Sivaporn Gatechompol, Vorapot Sapsirisavat, Wanida Thiansanguankul, Jiratchaya Sophonphan, Narujakorn Thammajaruk, Sasiwimol Ubolyam, David M Burger, Kiat Ruxrungtham
OBJECTIVES: To assess the efficacy and safety of a new single tablet regimen(STR) of tenofovir disoproxil fumarate(TDF) 300mg, lamivudine(3TC) 300mg and efavirenz(EFV) 600mg in HIV-infected Thais. METHODS: This was a 144 week, prospective study among 51 treatment naïve and 49 experienced patients on separated pill of TDF, 3TC and EFV with HIV RNA<50 copies/ml. CD4, HIV RNA, liver, renal functions and lipid profiles were assessed at baseline, weeks 12, 24, 48 and then every 24 weeks...
June 13, 2017: International Journal of Infectious Diseases: IJID
https://www.readbyqxmd.com/read/28607755/access-and-barriers-to-ms-care-in-latin-america
#2
REVIEW
Víctor M Rivera, Miguel Angel Macias
Multiple sclerosis (MS), an epidemiologically emergent disorder in Latin America (LATAM), poses substantial socioeconomic challenges to a region where most countries remain as economies in development. MS is not health priority despite its economic and communitarian impact with a relatively low prevalence. MS treatments in LATAM have evolved from earlier long-term oral steroids and immunosuppression protocols, to platform disease modifying therapies (DMTs), to the current landscape with more advanced therapeutic molecules...
January 2017: Multiple Sclerosis Journal—Experimental, Translational and Clinical
https://www.readbyqxmd.com/read/28603636/make-up-a-missed-lesson-new-policy-to-ensure-the-interchangeability-of-generic-drugs-in-china
#3
Baobin Huang, Sarah L Barber, Mingzhe Xu, Shuanghong Cheng
Generic drugs should be interchangeable with originators in terms of quality and efficacy. With relative lower prices, generic drugs are playing an important role in controlling health expenditures and ensuring access. However, the widespread understanding of "cheap price equals low quality" has a negative impact on the acceptance of generic drugs. In China, medical doctors doubt the efficacy and quality of generic drugs manufactured domestically. To address these concerns, the Chinese State Council released a policy in 2016 to ensure the interchangeability by re-evaluating the quality and efficacy of generic drugs...
June 2017: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28570572/optimal-costs-of-hiv-pre-exposure-prophylaxis-for-men-who-have-sex-with-men
#4
Jennie McKenney, Anders Chen, Karen W Hoover, Jane Kelly, David Dowdy, Parastu Sharifi, Patrick S Sullivan, Eli S Rosenberg
INTRODUCTION: Men who have sex with men (MSM) are disproportionately affected by HIV due to their increased risk of infection. Oral pre-exposure prophylaxis (PrEP) is a highly effictive HIV-prevention strategy for MSM. Despite evidence of its effectiveness, PrEP uptake in the United States has been slow, in part due to its cost. As jurisdictions and health organizations begin to think about PrEP scale-up, the high cost to society needs to be understood. METHODS: We modified a previously-described decision-analysis model to estimate the cost per quality-adjusted life-year (QALY) gained, over a 1-year duration of PrEP intervention and lifetime time horizon...
2017: PloS One
https://www.readbyqxmd.com/read/28559151/generic-imatinib-in-chronic-myeloid-leukemia-survival-of-the-cheapest
#5
Madhav Danthala, Sadashivudu Gundeti, Siva Prasad Kuruva, Krishna Chaitanya Puligundla, Praveen Adusumilli, Ashok Pillai Karnam, Stalin Bala, Meher Lakshmi Konatam, Lakshmi Srinivas Maddali, Raghunadha Rao Digumarti
INTRODUCTION: The patent expiration of imatinib mesylate (Gleevec; Novartis) on February 1, 2016, has brought the focus back on generic versions of the drug, and an opportunity to provide a safe and cost-effective alternative. The objective of our study was to determine the molecular and cytogenetic responses, survival endpoints (event-free survival, failure-free survival, transformation-free survival, overall survival), and safety of innovator and generic brands of imatinib. MATERIALS AND METHODS: In this retrospective analysis, data from 1812 patients with chronic myeloid leukemia treated with frontline imatinib mesylate (innovator/generic) at a single institution between 2008 and 2014 is included...
May 10, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28552057/exploitation-of-novel-molecular-targets-to-treat-idiopathic-pulmonary-fibrosis-a-drug-discovery-perspective
#6
Bhuvaneshwar Vaidya, Ruaab Patel, Aaron Muth, Vivek Gupta
BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is the most common fibrosing lung disease and is caused by excessive lung scarring. IPF-associated severe mortality can be attributed to late diagnosis due to its generic symptoms, and more importantly, due to the lack of effective therapies available. Despite extensive research in past decades, lung transplant still remains the most effective treatment for IPF. Though two drugs recently approved by FDA, Pirfenidone and Nintedanib, have shown an ability to reduce the progression of disease...
May 26, 2017: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/28539125/do-anti-malarials-in-africa-meet-quality-standards-the-market-penetration-of-non-quality-assured-artemisinin-combination-therapy-in-eight-african-countries
#7
Paul N Newton, Kara Hanson, Catherine Goodman
BACKGROUND: Quality of artemisinin-based combination therapy (ACT) is important for ensuring malaria parasite clearance and protecting the efficacy of artemisinin-based therapies. The extent to which non quality-assured ACT (non-QAACT), or those not granted global regulatory approval, are available and used to treat malaria in endemic countries is poorly documented. This paper uses national and sub-national medicine outlet surveys conducted in eight study countries (Benin, Kinshasa and Kantanga [Democratic Republic of the Congo, DRC], Kenya, Madagascar, Nigeria, Tanzania, Uganda and Zambia) between 2009 and 2015 to describe the non-QAACT market and to document trends in availability and distribution of non-QAACT in the public and private sector...
May 25, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28530519/does-a-one-size-fits-all-cost-sharing-approach-incentivize-appropriate-medication-use-a-roundtable-on-the-fairness-and-ethics-associated-with-variable-cost-sharing
#8
Jennifer S Graff, Chuck Shih, Thomas Barker, Gabriela Dieguez, Cheryl Larson, Helen Sherman, Robert W Dubois
BACKGROUND: Tiered formularies, in which patients pay copays or coinsurance out-of-pocket (OOP), are used to manage costs and encourage more efficient health care resource use. Formulary tiers are typically based on the cost of treatment rather than the medical appropriateness for the patient. Cost sharing may have unintended consequences on treatment adherence and health outcomes. Use of higher-cost, higher-tier medications can be due to a variety of factors, including unsuccessful treatment because of lack of efficacy or side effects, patient clinical or genetic characteristics, patient preferences to avoid potential side effects, or patient preferences based on the route of administration...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28506979/impact-of-ezetimibe-on-the-rate-of-cardiovascular-related-hospitalizations-and-associated-costs-among-patients-with-a-recent-acute-coronary-syndrome-results-from-the-improve-it-trial-improved-reduction-of-outcomes-vytorin-efficacy-international-trial
#9
Yashashwi Pokharel, Khaja Chinnakondepalli, Katherine Vilain, Kaijun Wang, Daniel B Mark, Glenn Davies, Michael A Blazing, Robert P Giugliano, Eugene Braunwald, Christopher P Cannon, David J Cohen, Elizabeth A Magnuson
BACKGROUND: Ezetimibe, when added to simvastatin therapy, reduces cardiovascular events after recent acute coronary syndrome. However, the impact of ezetimibe on cardiovascular-related hospitalizations and associated costs is unknown. METHODS AND RESULTS: We used patient-level data from the IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) to examine the impact of simvastatin-ezetimibe versus simvastatin-placebo on cardiovascular-related hospitalizations and related costs (excluding drug costs) over 7 years follow-up...
May 2017: Circulation. Cardiovascular Quality and Outcomes
https://www.readbyqxmd.com/read/28497561/on-assessing-bioequivalence-and-interchangeability-between-generics-based-on-indirect-comparisons
#10
Jiayin Zheng, Shein-Chung Chow, Mengdie Yuan
As more and more generics become available in the market place, the safety/efficacy concerns may arise as the result of interchangeably use of approved generics. However, bioequivalence assessment for regulatory approval among generics of the innovative drug product is not required. In practice, approved generics are often used interchangeably without any mechanism of safety monitoring. In this article, based on indirect comparisons, we proposed several methods to assessing bioequivalence and interchangeability between generics...
May 11, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28494654/new-formulations-of-tacrolimus-and-prevention-of-acute-and-chronic-rejections-in-adult-kidney-transplant-recipients
#11
Thomas Jouve, Lionel Rostaing, Paolo Malvezzi
​Introduction: As tolerance is not yet achievable, the kidney-transplanted-patients have to take on a daily-basis immunosuppressive drugs in order to avoid acute rejection-AR-. The cornerstone of immunosuppression relies on tacrolimus-therapy which is potentially nephrotoxic. Areas Covered: We identified from the studies published in the recent years those who were reporting on AR in de novo kidney-transplant recipients under tacrolimus-based therapy, as well as those who reported on the attempt to minimize tacrolimus-therapy...
May 31, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28448754/clinical-evaluation-of-cost-efficacy-of-drugs-for-treatment-of-osteoporosis-a-meta-analysis
#12
Stewart G Albert, Supraja Reddy
OBJECTIVE: To assess the cost efficacy of available regimens for therapy of osteoporosis as defined as the cost time's number need to treat to prevent one fracture. PATIENTS AND METHODS: Existing meta-analyses were supplemented through electronic databases SCOPUS and PubMED between 2013 (a date overlapping the latest meta-analyses) and March 2016. Primary references included all randomized controlled trials of anti-osteoporotic drugs versus comparators using search terms "osteoporosis", "random" and "trial"...
April 27, 2017: Endocrine Practice
https://www.readbyqxmd.com/read/28428513/-comparison-of-preparation-efficiency-and-therapeutic-safety-between-generic-products-of-gemcitabine
#13
Yuhki Sato, Hiroyuki Ono, Kohei Amada, Ryosuke Nakahara, Hiroki Itoh
Because generic medicines reduce the financialburden on patients and medicalinsurance providers, they have become increasingly popular. However, there are only a few reports that have analyzed the efficacy and safety of generic medicines, especially in terms of their characteristics and side effects. Gemcitabine is an antineoplastic drug that is frequently used with good results in the treatment of lung cancer, pancreatic cancer, breast cancer, ovarian cancer, and malignant lymphoma. However, its fat solubility is high, and several adverse events, such as myelosuppression, are known to develop during its use...
April 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28381720/practice-of-regulatory-science-development-of-medical-devices
#14
REVIEW
Shingo Niimi
 Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28375404/hot-topics-in-primary-care-demystifying-the-differences-follow-on-biologics-biosimilars-and-generics
#15
REVIEW
Eugene E Wright, Thomas C Blevins, Beverly Reed, Roy Daniel Pollom
Sponsors of follow-on biologics can submit their applications for approval by the US Food and Drug Administration (FDA) under 2 distinct pathways. The submission pathway is determined by the pathway previously used by the reference biologic product, which is the biologic product upon which the follow-on product relies for evidence of safety and efficacy.
April 2017: Journal of Family Practice
https://www.readbyqxmd.com/read/28373759/insights-on-the-use-of-biosimilars-in-the-treatment-of-inflammatory-bowel-disease
#16
REVIEW
Michael K Zheng, David Q Shih, Gary C Chen
Biologic therapy, such as those that target tumor necrosis factor (TNF) signaling, has proven to be an efficacious method of treatment for patients with inflammatory bowel disease (IBD) with regards to symptom management and mucosal healing. However, the rising prevalence of IBD worldwide and the ever-increasing burden of biologic pharmaceuticals in the health care industry is alarming for insurance companies, clinicians, and patients. The impending patent expiry and the relatively high costs of biologics, particularly anti-TNF agents, have paved the way for biosimilar development for IBD...
March 21, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28363098/brand-to-generic-levetiracetam-switch-in-patients-with-epilepsy-in-a-routine-clinical-setting
#17
Sofia Markoula, Dimitrios Chatzistefanidis, Stylianos Gatzonis, Anna Siatouni, Eleftheria Siarava, Anastasia Verentzioti, Athanassios P Kyritsis, Philip N Patsalos
PURPOSE: The therapeutic equivalence of generic and brand antiepileptic drugs, based on studies performed on healthy volunteers, has been questioned. We compare, in a routine clinical setting, brand versus generic levetiracetam (LEV) bioequivalence in patients with epilepsy and also the clinical efficacy and tolerability of the substitution. METHODS: A prospective, open-label, non-randomized, steady-state, multiple-dose, bioequivalence study was conducted in 12 patients with epilepsy (5 females), with a mean age of 38...
March 19, 2017: Seizure: the Journal of the British Epilepsy Association
https://www.readbyqxmd.com/read/28360236/spin-in-rcts-of-anxiety-medication-with-a-positive-primary-outcome-a-comparison-of-concerns-expressed-by-the-us-fda-and-in-the-published-literature
#18
Lian Beijers, Bertus F Jeronimus, Erick H Turner, Peter de Jonge, Annelieke M Roest
OBJECTIVES: This study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper. METHODS: For every positive anxiety medication trial with a matching publication (n=41), two independent reviewers identified the concerns raised in the US FDA reviews and those in the published literature...
March 29, 2017: BMJ Open
https://www.readbyqxmd.com/read/28346107/a-high-throughput-method-for-measuring-drug-residence-time-using-the-transcreener-adp-assay
#19
Meera Kumar, Robert G Lowery
Analysis of drug-target residence times during drug development can result in improved efficacy, increased therapeutic window, and reduced side effects. Residence time can be estimated as the reciprocal of the dissociation rate ( koff) of an inhibitor from its target. The traditional methods for measuring koff require synthesis of labeled ligands or low-throughput label-free methods. To provide an alternative that is better suited to an automated high-throughput screening (HTS) environment, we adapted a classic "jump dilution" catalytic assay method for determination of koff values for kinase inhibitor drugs...
February 1, 2017: SLAS Discovery
https://www.readbyqxmd.com/read/28292999/-outcomes-of-an-independent-clinical-study-to-compare-branded-and-generic-formulations-of-sustained-release-oxycodone
#20
COMPARATIVE STUDY
Mai Yamamoto, Yoshiko Saito, Yurika Onodera, Masayo Okawa, Kei Shimizu, Yusuke Yamamoto, Takeshi Nawa, Yoshifumi Aoyama
To evaluate the potential for the adoption of a generic formulation of sustained-release oxycodone(Oxycodone SR Capsules), an independent clinical study was planned to accurately evaluate the efficacy and safety during a 9-day period. After a 3-day pretreatment period, the generic formulation was administered to patients with progressive cancer, who had been treated with a branded formulation(OxyContin®Tablets)of the drug for 5 days at the same dose. This was followed by a 1- day observation period. Drug administration to 3 patients with pulmonary cancer achieved the primary(dose, pain level, and adverse drug reactions)and secondary(rescue dose frequency and quality of life)endpoints, as well as safety goals...
March 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
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