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Efficacy of generic drugs

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https://www.readbyqxmd.com/read/28793071/nonbioequivalent-prescription-drug-interchangeability-concerns-on-patient-safety-and-drug-market-dynamics-in-brazil
#1
Francisco José Roma Paumgartten, Ana Cecilia Amado Xavier de Oliveira
Since the enforcement of Generics Act (1999), three types of pharmaceutically equivalent products are marketed in Brazil: innovative reference (REF), "similar" (S) and generic (G) drugs. The S (brand name) and G (generic name) borrow from REF (brand name) clinical data on safety and efficacy and dosage regimen. G (but not S) is bioequivalent to and interchangeable with REF. Starting in 2003, Brazilian Sanitary Surveillance Agency (Anvisa) has required data on relative bioavailability tests (with REF) to approve (or renew registration of) S drugs...
August 2017: Ciência & Saúde Coletiva
https://www.readbyqxmd.com/read/28782339/role-of-generics-in-treatment-of-hepatitis-c-infection
#2
Muhammad Umar, Tayyab Saeed Akhter, Ibrar Akbar, Gul Nisar, Muhammad Osama, Tayyab Saeed Akhter
With the discovery of newer and newer DAAs, the cure of Hepatitis C seems to be a reality. But their high price and availability is a big hindrance. Sofosbuvir launched by Gilead costs about $ 84000 per 12-week course. Since its launch there is a huge debate regarding the complex pricing mechanism of DAAs. The pricing involves negotiation of patent holder with health insurance companies through their Pharmacy Benefit Managers (PBMs). Several rebates are also involved in this pricing mechanism amongst which only few are declared ones...
October 2016: Journal of Ayub Medical College, Abbottabad: JAMC
https://www.readbyqxmd.com/read/28756597/treatments-for-metastatic-prostate-cancer-mpc-a-review-of-costing-evidence
#3
REVIEW
Jan Norum, Carsten Nieder
BACKGROUND: Prostate cancer (PC) is the most common cancer in Western countries. More than one third of PC patients develop metastatic disease, and the 5-year expected survival in distant disease is about 35%. During the last few years, new treatments have been launched for metastatic castrate-resistant prostate cancer (mCRPC). OBJECTIVES: We aimed to review the current literature on health economic analysis on the treatment of metastatic prostate cancer (mPC), compare the studies, summarize the findings and make the results available to administrators and decision makers...
July 29, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28736014/efficacy-and-safety-of-generic-mycophenolate-mofetil-my-rept-500-milligram-tablets-in-primary-liver-transplant-recipients
#4
S K Hong, K-W Lee, K C Yoon, H-S Kim, H Kim, N-J Yi, K-S Suh
BACKGROUND: Generic immunosuppressants may be cost-effective if clinical outcomes are equivalent to the brand-name medications. Mycophenolate mofetil in the form of My-rept may be cost-effective being a generic immunosuppressant, which is available as a 500-mg tablet as well as a 250-mg capsule (Chong Kun Dang Pharmaceutical Corporation, Seoul, Korea). OBJECTIVE: This study aimed to evaluate the efficacy, safety, cost-effectiveness, and convenience of My-rept 500-mg tablets in liver transplant recipients...
July 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/28730957/design-preparation-and-characterization-of-modular-squalene-based-nanosystems-for-controlled-drug-release
#5
Jiao Feng, Sinda Lepetre-Mouelhi, Patrick Couvreur
This article reviews the innovative and original concept the "squalenoylation", a technology allowing the formulation of a wide range of drug molecules (both hydrophilic and lipophilic) as nanoparticles. The "squalenoylation" approach is based on the covalent linkage between the squalene, a natural and biocompatible lipid belonging to the terpenoid family, and a drug, in order to increase its pharmacological efficacy. Fundamentally, the dynamically folded conformation of squalene triggers the resulting squalene-drug bioconjugates to self-assemble as nanoparticles of 100-300 nm...
July 19, 2017: Current Topics in Medicinal Chemistry
https://www.readbyqxmd.com/read/28716156/generic-atorvastatin-is-as-effective-as-the-brand-name-drug-lipitor-%C3%A2-in-lowering-cholesterol-levels-a-cross-sectional-retrospective-cohort-study
#6
Alexander Loch, Jan Philipp Bewersdorf, Daniel Kofink, Dzafir Ismail, Imran Zainal Abidin, Ramesh Singh Veriah
BACKGROUND: In a world of ever increasing health care costs, generic drugs represent a major opportunity to ensure access to essential medicines for people who otherwise would be unable to afford them. However, some clinicians and patients are still questioning the safety and effectiveness of generic formulations compared to the proprietary drugs necessitating further systematic research analyzing the generic drugs' efficacy. Our objective was to compare the lipid lowering effects of generic and branded atorvastatin...
July 17, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/28678853/randomized-clinical-trial-comparing-efficacy-and-safety-of-brand-versus-generic-alendronate-bonmax%C3%A2-for-osteoporosis-treatment
#7
Aasis Unnanuntana, Atthakorn Jarusriwanna, Panupan Songcharoen
INTRODUCTION: Although the same efficacy and tolerability are anticipated due to both drugs containing the same active ingredients, comparative studies between brand and generic alendronate are limited. Accordingly, the objective of this study was to compare efficacy and safety between brand alendronate and a recently introduced generic alendronate drug. METHODS: A total of 140 postmenopausal women or men aged older than 50 years who met the indications for osteoporosis treatment were randomized to receive either generic (Bonmax®) or brand alendronate (Fosamax®) 70 mg/week over a 12-month period during the May 2014 to June 2015 study period...
2017: PloS One
https://www.readbyqxmd.com/read/28675307/pharmacokinetic-drug-evaluation-of-paliperidone-in-the-treatment-of-schizoaffective-disorder
#8
REVIEW
Matthew Macaluso, Hannah Oliver, Zohaib Sohail
This paper reviews the pharmacokinetics, receptor binding, clinical efficacy and safety of paliperidone in the treatment of patients with schizoaffective disorder. Areas covered: We reviewed the literature using keywords 'paliperidone', 'schizoaffective disorder' and 'clinical trials' with a focus on seminal data papers and information that is clinically relevant to the treatment of schizoaffective disorder. The purpose of this paper is to provide a clinically oriented review of the pharmacokinetic and pharmacodynamic properties of paliperidone including receptor binding, clinical efficacy, safety and tolerability...
August 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28658202/pharmacokinetics-and-clinical-outcomes-of-generic-tacrolimus-hexal-versus-branded-tacrolimus-in-de-novo-kidney-transplant-patients-a-multicenter-randomized-trial
#9
Wolfgang Arns, Andrea Huppertz, Thomas Rath, Stephan Ziefle, Lars C Rump, Anita Hansen, Klemens Budde, Lukas J Lehner, Maria Shipkova, Daniel Baeumer, Irena Kroeger, Christian Sieder, Thomas Klein, Peter Schenker
BACKGROUND: Scrupulous comparison of the pharmacokinetic and clinical characteristics of generic tacrolimus formulations versus the reference drug (Prograf) is essential. Pharmacokinetics of the TacHexal formulation are similar to Prograf in stable renal transplant patients but data in de novo patients is lacking. METHODS: De novo kidney transplant patients were randomized to generic tacrolimus (Tacrolimus Hexal [TacHexal]) or Prograf in a 6-month open-label study...
June 28, 2017: Transplantation
https://www.readbyqxmd.com/read/28627427/efficacy-and-safety-of-a-once-daily-single-tablet-regimen-of-tenofovir-lamivudine-and-efavirenz-assessed-at-144-weeks-among-antiretroviral-na%C3%A3-ve-and-experienced-hiv-1-infected-thai-adults
#10
Anchalee Avihingsanon, Wirach Maek-A-Nantawat, Sivaporn Gatechompol, Vorapot Sapsirisavat, Wanida Thiansanguankul, Jiratchaya Sophonphan, Narujakorn Thammajaruk, Sasiwimol Ubolyam, David M Burger, Kiat Ruxrungtham
OBJECTIVE: 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 Thai patients. METHODS: This was a prospective study performed for 144 weeks among 51 treatment-naïve patients and 49 experienced patients on separate tablets of TDF, 3TC, and EFV with HIV RNA<50 copies/ml. CD4, HIV RNA, liver and renal function, and lipid profiles were assessed at baseline, weeks 12, 24, and 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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
REVIEW
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...
July 2017: Expert Opinion on Drug Safety
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