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Efficacy of generic drugs

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https://www.readbyqxmd.com/read/29044101/controlling-the-bioactivity-of-a-peptide-hormone-in-vivo-by-reversible-self-assembly
#1
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
#2
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
#3
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
#4
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
#5
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
https://www.readbyqxmd.com/read/28991670/follow-on-products-for-treatment-of-multiple-sclerosis-in-latin-america-an-update
#6
REVIEW
Jorge Correale
Both proprietary and non-proprietary medicines are expected to undergo rigorous pre-approval testing and both should meet stringent health authority regulatory requirements related to quality to obtain approval. Non-proprietary (also known as copy or generic) medicines, which base their authorization and use on the proprietary documentation and label, are often viewed as a means to help lower cost and thus increase patient access. If these medicines fail to meet quality standards, such as good manufacturing practice and bioequivalence (in humans), they are then defined as substandard copies and can pose serious risks to patients in terms of safety and efficacy...
October 15, 2017: Journal of the Neurological Sciences
https://www.readbyqxmd.com/read/28988700/differences-in-adverse-event-reporting-rates-of-therapeutic-failure-between-two-once-daily-extended-release-methylphenidate-medications-in-canada-analysis-of-spontaneous-adverse-event-reporting-databases
#7
Laura Park-Wyllie, Judy van Stralen, Genaro Castillon, Stephen E Sherman, Doron Almagor
PURPOSE: Our study evaluated adverse events of therapeutic failure (and specifically reduced duration of action) with the use of a branded product, Osmotic Release Oral System (OROS) methylphenidate, which is approved for the treatment of attention deficit/hyperactivity disorder, and a generic product (methylphenidate, methylphenidate ER-C), which was approved for marketing in Canada based on bioequivalence to OROS methylphenidate. This study was initiated following reports that some US-marketed generic methylphenidate ER products had substantially higher reporting rates of therapeutic failure than did the referenced brands...
October 5, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28976412/switch-from-originator-to-equivalent-drug-in-the-era-of-generic-antiepileptic-drugs-study-of-keppra-versus-epitiram-clinical-equivalence
#8
Martina Fanella, Alessandra Morano, Jinane Fattouch, Mariarita Albini, Luca M Basili, Sara Casciato, Mario Manfredi, Anna T Giallonardo, Carlo Di Bonaventura
OBJECTIVES: Generic antiepileptic drugs represent a measure to maximize cost saving. Levetiracetam (LEV) is one of most commonly used and effective antiepileptic drugs. The objective of our work was to demonstrate the effectiveness and safety of overnight switch from monotherapy with Keppra (original drug) to epitiram (generic drug) at the same dose. METHODS: In our observational study, we consecutively enrolled 37 seizure-free patients with epilepsy who expressed the wish to switch to a generic drug for economic reasons...
October 2, 2017: Clinical Neuropharmacology
https://www.readbyqxmd.com/read/28970713/chronic-hepatitis-c-do-generics-work-as-well-as-branded-drugs
#9
REVIEW
Madhumita Premkumar, Gagandeep S Grover, Radha K Dhiman
India has a large share of the hepatitis C virus (HCV) burden of the world. Unsafe medical practices and blood transfusions are the leading modes of transmission of HCV in India. The commonest HCV genotype in India is genotype 3 followed by genotype 1. While directly acting antivirals (DAAs) agents have become available at reasonable rates in India, cost of therapy remains a major barrier for control of HCV in India. Generic DAAs have been proven to be cost-saving in prior studies. We examined data from various studies in India and elsewhere using generic DAAs, and evaluated whether they are equally efficacious as the branded drugs...
September 2017: Journal of Clinical and Experimental Hepatology
https://www.readbyqxmd.com/read/28970702/generic-direct-acting-antivirals-in-treatment-of-chronic-hepatitis-c-infection-in-patients-of-thalassemia-major
#10
Aabha Nagral, Smita Sawant, Nishtha Nagral, Pathik Parikh, Priya Malde, Rashid Merchant
BACKGROUND: There is no published data of treating hepatitis C in thalassemia major patients with any sofosbuvir based direct acting antivirals (DAAs). This study was performed to determine the efficacy and safety of these regimes using generic drugs in the thalassemia major population. METHODS: In this observational study, 902 patients of thalassemia major from five transfusion centres in Mumbai were screened for HCV antibody. Of the 120 positive patients, HCV RNA was detected in 50%...
September 2017: Journal of Clinical and Experimental Hepatology
https://www.readbyqxmd.com/read/28957646/a-high-throughput-dose-response-cellular-thermal-shift-assay-for-rapid-screening-of-drug-target-engagement-in-living-cells-exemplified-using-smyd3-and-ido1
#11
Dean E McNulty, William G Bonnette, Hongwei Qi, Liping Wang, Thau F Ho, Anna Waszkiewicz, Lorena A Kallal, Raman P Nagarajan, Melissa Stern, Amy M Quinn, Caretha L Creasy, Dai-Shi Su, Alan P Graves, Roland S Annan, Sharon M Sweitzer, Marc A Holbert
A persistent problem in early small-molecule drug discovery is the frequent lack of rank-order correlation between biochemical potencies derived from initial screens using purified proteins and the diminished potency and efficacy observed in subsequent disease-relevant cellular phenotypic assays. The introduction of the cellular thermal shift assay (CETSA) has bridged this gap by enabling assessment of drug target engagement directly in live cells based on ligand-induced changes in protein thermal stability...
September 1, 2017: SLAS Discovery
https://www.readbyqxmd.com/read/28927712/real-world-data-on-rufinamide-treatment-in-patients-with-lennox-gastaut-syndrome-results-from-a-european-noninterventional-registry-study
#12
Marina Nikanorova, Christian Brandt, Stéphane Auvin, Rob McMurray
INTRODUCTION: Rufinamide is approved for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged ≥4years. The objective of this study was to provide real-world, long-term data on patients with LGS initiating rufinamide as add-on therapy and patients with LGS receiving other antiepileptic drugs (AEDs). METHODS: A Phase IV, noninterventional, multicenter registry study was conducted in patients with LGS aged ≥4years requiring modification to any AED treatment, including initiation of add-on rufinamide therapy...
September 15, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28926095/model-based-assessment-using-conventional-bioequivalence-limits-to-ensure-safety-and-efficacy-of-rivaroxaban-in-patients-undergoing-hip-or-knee-replacement
#13
Mario González-Sales, Lanyan Fang, Myong-Jin Kim, Liang Zhao
We evaluated whether the current bioequivalence limit is adequate to ensure safety and efficacy of rivaroxaban in patients under total hip arthroplasty and total knee arthroplasty based on its model informed benefit/risk profile. Clinical data from a total of 7145 patients from 3 phase 2 and 4 phase 3 clinical trials were included in the current model-based exposure-response analysis. The relationships between rivaroxaban exposure measurements (ie, minimum or trough, maximum, average concentration, and area under the concentration-time curve [AUC] at steady state) and clinical outcomes (ie, the probabilities of major bleeding [MB] and venous thromboembolism [VTE]) were modeled using NONMEM 7...
September 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28898589/science-of-biosimilars
#14
R Donald Harvey
Biosimilar therapeutic proteins in oncology offer the potential to decrease costs while providing safety and efficacy profiles consistent with their respective reference or originator products. Biosimilars have a number of important differences from generic small-molecule drugs, including manufacturing processes that are unique from their reference products. These differences may affect biosimilars through posttranslational modifications that can occur in specific cellular production lines, and these modifications have potential effects on protein structure, function, clinical pharmacology, and immunogenicity...
September 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28880625/biosimilar-monoclonal-antibodies-mabs-in-oncology
#15
Caroline Moore
Biological medicines are derived from living cells and organisms. Monoclonal antibodies (mAbs) are biological agents that are widely used to treat malignancies including non-Hodgkin's lymphomas and chronic lymphocytic leukaemia. They are effective but expensive. The patents for many mAbs are expiring, so biosimilar medicines, which contain a version of the active ingredient of the original drug, are being developed. Biological medicines cannot be assessed in the same way as standard generic medications because they are difficult to copy and can change over time...
September 7, 2017: British Journal of Nursing: BJN
https://www.readbyqxmd.com/read/28871223/effects-of-enzymatically-depolymerized-low-molecular-weight-heparins-on-ccl4-induced-liver-fibrosis
#16
Yishu Yan, Changge Guan, Shanshan Du, Wenming Zhu, Yang Ji, Nan Su, Xiang Mei, Dong He, Yuan Lu, Chong Zhang, Xin-Hui Xing
With regard to identifying the effective components of LMWH drugs curing hepatic fibrosis disease, we carried out a comparative study on the efficacy of enzymatically depolymerized LMWHs on CCl4 induced mouse liver fibrosis. The results showed that the controlled enzymatic depolymerization conditions resulted in LMWHs with significantly different activities. The LMWH product depolymerized by Heparinase I (I-11) with a Mw of 7160, exhibited a significant advantage in reducing the liver inflammation by suppressing TNF-α and IL-1β secretion, and minimizing hepatic fibrogenesis...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28860725/approval-rating-and-opinion-of-outpatients-and-general-practitioners-toward-generic-drugs-a-questionnaire-based-real-world-study
#17
F Mattioli, G Siri, F Castelli, M Puntoni, M L Zuccoli, A Stimamiglio, A Martelli
PURPOSE: Generic drugs use in the Liguria region is higher than the Italian average, but lower than in other European countries. No data exist about real-life prescription and level of awareness of generic drugs. In this study, we analyzed demographic, social, economic and cultural factors that may affect the level of awareness of generic drugs and their effective use. METHODS: We conducted a population survey using a structured questionnaire, administered to a sample of 8 outpatient clinics of general practitioners located in different districts of Genoa (Liguria, Italy)...
2017: Patient Preference and Adherence
https://www.readbyqxmd.com/read/28844599/generic-imatinib-therapy-among-jordanians-an-observational-assessment-of-efficacy-and-safety-in-routine-clinical-practice
#18
Abdalla Awidi, Salah Abbasi, Kamal Alrabi, Khalid A Kheirallah
INTRODUCTION: Generic imatinib therapy is being globally considered owing to cost considerations. However, evidence of its efficacy and safety in Middle Eastern clinical settings is scarce. PATIENTS AND METHODS: The efficacy and safety of generic imatinib (Cemivil) were assessed among Jordanian patients diagnosed with chronic myeloid leukemia using an observational, multicenter, prospective study design. Responses were defined using European LeukemiaNet 2009 guidelines and assessed by complete blood counts, fluorescence in situ hybridization, and real-time quantitative polymerase chain reaction...
August 5, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28829910/oxycodone-for-cancer-related-pain
#19
REVIEW
Mia Schmidt-Hansen, Michael I Bennett, Stephanie Arnold, Nathan Bromham, Jennifer S Hilgart
BACKGROUND: Many people with cancer experience moderate to severe pain that requires treatment with strong opioids, such as oxycodone and morphine. Strong opioids are, however, not effective for pain in all people, neither are they well-tolerated by all people. The aim of this review was to assess whether oxycodone is associated with better pain relief and tolerability than other analgesic options for adults with cancer pain. This is an updated version of the original Cochrane review published in 2015, Issue 2 on oxycodone for cancer-related pain...
August 22, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28793071/nonbioequivalent-prescription-drug-interchangeability-concerns-on-patient-safety-and-drug-market-dynamics-in-brazil
#20
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
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