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Efficacy of generic drugs

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https://www.readbyqxmd.com/read/28292999/-outcomes-of-an-independent-clinical-study-to-compare-branded-and-generic-formulations-of-sustained-release-oxycodone
#1
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
https://www.readbyqxmd.com/read/28290847/-comparative-analysis-of-the-efficacy-and-safety-of-rosuvastatin-and-original-rosuvastatin
#2
B Ya Bart, E E Luchinkina, I G Gordeev, G P Arutyunov, E O Taratukhin On Behalf Of The Workgroup Of Paritet Trial
The study is one of the priority points of the Russian Scientific Medical Society of Internal Medicine, initiated due to known high average level of LDL cholesterol in Russian population and necessity for its optimized control by better access to treatment. AIM: To conduct comparative analysis of efficacy and safety of the rosuvastatin compound akorta and original rosuvastatin crestor. MATERIAL AND METHODS: To randomized crossover study (PARITET) 60 patients were included with the diagnosis dyslipidemia...
June 2016: Kardiologiia
https://www.readbyqxmd.com/read/28240353/carbamazepine-versus-phenytoin-monotherapy-for-epilepsy-an-individual-participant-data-review
#3
REVIEW
Sarah J Nevitt, Anthony G Marson, Jennifer Weston, Catrin Tudur Smith
BACKGROUND: This is an updated version of the original Cochrane Review published in Issue 2, 2002 and its subsequent updates in 2010 and 2015.Epilepsy is a common neurological condition in which recurrent, unprovoked seizures are caused by abnormal electrical discharges from the brain. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure-free and go into long-term remission shortly after starting drug therapy with a single antiepileptic drug in monotherapy...
February 27, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28236795/therapeutic-monitoring-of-pediatric-transplant-patients-with-conversion-to-generic-tacrolimus
#4
Natalia Riva, Paulo Cáceres Guido, Nieves Licciardone, Oscar Imventarza, Marta Monteverde, Raquel Staciuk, Alberto Charroqui, Paula Schaiquevich
OBJECTIVE: Therapeutic monitoring during interchange of tacrolimus commercial formulations is essential to ensure similar exposure in transplant patients. However, there are limited data in the pediatric transplant population. This study aims to evaluate exposure, safety and efficacy in maintenance pediatric transplant patients under generic tacrolimus substitution. METHOD: Pediatric patients who underwent interchange of tacrolimus formulations were detected by the Service of Pharmacy and included in this study...
March 1, 2017: Farmacia Hospitalaria
https://www.readbyqxmd.com/read/28182873/biomechanically-primed-liver-microtumor-array-as-a-high-throughput-mechanopharmacological-screening-platform-for-stroma-reprogrammed-combinatorial-therapy
#5
Lu Zhu, Xingliang Fan, Bingjie Wang, Longwei Liu, Xiaojun Yan, Lyu Zhou, Yang Zeng, Mark C Poznansky, Lili Wang, Huabiao Chen, Yanan Du
Recent breakthrough in stroma-reprogrammed combinatorial therapy (SRCT) for pancreatic tumor opens a new route for improving conventional chemotherapeutic efficacy, which utilizes VDR ligand to reprogram activated stromal cells in stiffened microenvironment, leading to reduced 'barrier effects' and increased tissue-infiltration of the chemotherapy drug. As a novel therapeutic strategy and mechanism of action, the progress of SRCT relies on tailored in vitro drug assessment platforms to further optimize its efficacy and extend to applications in other tumor types...
January 27, 2017: Biomaterials
https://www.readbyqxmd.com/read/28178199/combined-use-of-delamanid-and-bedaquiline-to-treat-multidrug-resistant-and-extensively-drug-resistant-tuberculosis-a-systematic-review
#6
REVIEW
Giovanni Battista Migliori, Emanuele Pontali, Giovanni Sotgiu, Rosella Centis, Lia D'Ambrosio, Simon Tiberi, Marina Tadolini, Susanna Esposito
The new drugs delamanid and bedaquiline are increasingly being used to treat multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB). The World Health Organization, based on lack of evidence, recommends their use under specific conditions and not in combination. No systematic review has yet evaluated the efficacy, safety, and tolerability of delamanid and bedaquiline used in combination. A search of peer-reviewed, scientific evidence was carried out, aimed at evaluating the efficacy/effectiveness, safety, and tolerability of delamanid and bedaquiline-containing regimens in individuals with pulmonary/extrapulmonary disease, which were bacteriologically confirmed as M/XDR-TB...
February 7, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28164249/extrapolation-and-interchangeability-of-infliximab-and-adalimumab-in-inflammatory-bowel-disease
#7
REVIEW
Shannon Chang, Stephen Hanauer
Infliximab and adalimumab biosimilars have been approved by the FDA and European Medicines Agency and have already been introduced to the international market. Availability into the US market is imminent. Biosimilars are highly similar to the reference biologic product but should not be referred to as, nor equated with, generic medications as no two biosimilars can ever be identical. Regulatory pathways for biosimilar approval consider the totality of evidence for biosimilar approvals, but the preponderance of development relies on analytic and functional testing and allows extrapolation between indications to reduce the financial burden of completing comparative clinical trials for each indication...
March 2017: Current Treatment Options in Gastroenterology
https://www.readbyqxmd.com/read/28152215/comparison-of-generic-to-brand-switchback-rates-between-generic-and-authorized-generic-drugs
#8
Richard A Hansen, Jingjing Qian, Richard Berg, James Linneman, Enrique Seoane-Vazquez, Sarah K Dutcher, Saeid Raofi, C David Page, Peggy Peissig
STUDY OBJECTIVE: Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. The objective of this study was to compare generic-to-brand switchback rates between generic and authorized generic drugs. DESIGN: Retrospective cohort study...
February 2, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28138224/comparison-of-the-long-term-efficacy-and-safety-of-generic-tacrobell-with-original-tacrolimus-prograf-in-kidney-transplant-recipients
#9
Seung Yeon Son, Hye Ryoun Jang, Jung Eun Lee, Heejin Yoo, Kyunga Kim, Jae Berm Park, Sung Joo Kim, Ha Young Oh, Wooseong Huh
This study aimed to evaluate the long-term efficacy and safety of a generic tacrolimus (Tacrobell [TCB]) compared to the original tacrolimus (Prograf [PGF]) in kidney transplant recipients. In this retrospective observational study, we analyzed the data from 444 patients who took TCB as a first-line immunosuppressive drug and 245 patients who took PGF. The 5-year graft survival rate was 92% for patients in the PGF group and 97% for patients in the TCB group, respectively. Cox proportional hazards for a one-sided, noninferiority model showed noninferiority (upper confidence interval [CI] limit of the hazard ratio [HR]<1...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28129702/triptans-and-migraine-advances-in-use-administration-formulation-and-development
#10
REVIEW
Amanda E Macone, Michael D Perloff
Recent triptan development has focused on new administration methods and formulations, triptan combination therapies, treatment in menstrually related migraines, and novel serotonin receptor subtype agonists (5HTf). Areas covered: Clinical triptan research related to migraine was reviewed, analyzing EMBASE and PUBMED data bases from 01/01/2011 to 06/29/2016, with a focus on clinical trials of class 1 or 2 level of evidence. There have been advances in drug combination therapies, as well as administration devices that aid in ease of use, increase efficacy, and decrease adverse reactions...
March 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28120254/application-of-pharmacokinetics-and-pharmacodynamics-in-product-life-cycle-management-a-case-study-with-a-carbidopa-levodopa-extended-release-formulation
#11
Nishit B Modi
Increasing costs in discovering and developing new molecular entities and the continuing debate on limited company pipelines mean that pharmaceutical companies are under significant pressure to maximize the value of approved products. Life cycle management in the context of drug development comprises activities to maximize the effective life of a product. Life cycle approaches can involve new formulations, new routes of delivery, new indications or expansion of the population for whom the product is indicated, or development of combination products...
January 24, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28090798/switching-from-branded-to-generic-glatiramer-acetate-15-month-gate-trial-extension-results
#12
Krzysztof Selmaj, Frederik Barkhof, Anna N Belova, Christian Wolf, Evelyn Rw van den Tweel, Janine Jl Oberyé, Roel Mulder, David F Egging, Norbert P Koper, Jeffrey A Cohen
BACKGROUND: Open-label 15-month follow-up of the double-blind, placebo-controlled Glatiramer Acetate clinical Trial to assess Equivalence with Copaxone(®) (GATE) trial. OBJECTIVE: To evaluate efficacy, safety, and tolerability of prolonged generic glatiramer acetate (GTR) treatment and to evaluate efficacy, safety, and tolerability of switching from brand glatiramer acetate (GA) to GTR treatment. METHODS: A total of 729 patients received GTR 20 mg/mL daily...
January 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28086866/perceptions-and-utilization-of-generic-medicines-in-guatemala-a-mixed-methods-study-with-physicians-and-pharmacy-staff
#13
David Flood, Irène Mathieu, Anita Chary, Pablo García, Peter Rohloff
BACKGROUND: Access to low-cost essential generic medicines is a critical health policy goal in low-and-middle income countries (LMICs). Guatemala is an LMIC where there is both limited availability and affordability of these medications. However, attitudes of physicians and pharmacy staff regarding low-cost generics, especially generics for non-communicable diseases (NCDs), have not been fully explored in Guatemala. METHODS: Semi-structured interviews with 30 pharmacy staff and 12 physicians in several highland towns in Guatemala were conducted...
January 13, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28081041/a-systematic-literature-review-approach-to-estimate-the-therapeutic-index-of-selected-immunosuppressant-drugs-after-renal-transplantation
#14
Jessica E Ericson, Kanecia O Zimmerman, Daniel Gonzalez, Chiara Melloni, Jeffrey T Guptill, Kevin D Hill, Huali Wu, Michael Cohen-Wolkowiez
BACKGROUND: Drugs that exhibit close margins between therapeutic and toxic blood concentrations are considered to have a narrow therapeutic index (NTI). The Food and Drug Administration has proposed that NTI drugs should have more stringent bioequivalence standards for approval of generic formulations. However, many immunosuppressant drugs do not have a well-defined therapeutic index (TI). METHODS: We sought to determine whether safety, efficacy, and pharmacokinetic data obtained from the medical literature through a comprehensive literature search could be used to estimate the TI of cyclosporine, tacrolimus, and sirolimus...
February 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28068463/long-term-acute-phase-treatment-with-antidepressants-8-weeks-and-beyond-a-systematic-review-and-meta-analysis-of-randomized-placebo-controlled-trials
#15
Jonathan Henssler, Mona Kurschus, Jeremy Franklin, Tom Bschor, Christopher Baethge
OBJECTIVE: In clinical practice, acute antidepressant treatment is often applied for several months until remission is achieved. However, data on treatment outcomes beyond 8 weeks are sparse and no systematic review exists to date. This study aims at assessing efficacy and tolerability of antidepressants compared to placebo in acute treatment at and beyond 8 weeks. DATA SOURCES: MEDLINE, Embase, PsycINFO, and CENTRAL databases were systematically searched through March 2014 using generic terms for depressive and affective disorders combined with generic terms for individual drugs and placebo...
January 3, 2017: Journal of Clinical Psychiatry
https://www.readbyqxmd.com/read/28045649/cost-effectiveness-of-pemetrexed-in-combination-with-cisplatin-as-first-line-treatment-for-patients-with-advanced-non-squamous-non-small-cell-lung-cancer-in-spain
#16
Jonathan González García, Fernando Gutiérrez Nicolás, Gloria Julia Nazco Casariego, Cristina Valcárcel Nazco, Jose Norberto Batista López, Juana Oramas Rodríguez
INTRODUCTION: Lung cancer is the third most frequent neoplastic tumour in Spain, with around 27 000 new cases diagnosed per year; 80-95% of these are non-small-cell cancer (NSCLC), and the majority of cases are diagnosed in advanced stages of the disease, and for this reason it is one of the oncologic conditions with higher mortality rates (21.4% mean survival at 5 years). The main treatment regimens used for first-line treatment of NSCLC are: cisplatin/pemetrexed (cis/pem), cisplatin/gemcitabine/ bevacizumab (cis/gem/bev), and carboplatin/paclitaxel/ bevacizumab (carb/pac/bev)...
January 1, 2017: Farmacia Hospitalaria
https://www.readbyqxmd.com/read/28034518/sex-effect-on-average-bioequivalence
#17
Manuel Ibarra, Marta Vázquez, Pietro Fagiolino
PURPOSE: Generic formulations are by far the most prescribed drugs. This scenario is highly beneficial for society because medication expenses are significantly reduced after expiration of the exclusivity period conceded to the branded name drug. Correspondingly, these formulations must be adequately evaluated to avoid drug inefficacy and toxicity in the overall patient population. Bioequivalence studies are the only in vivo evaluation that a generic drug must overcome to reach the market...
January 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28027918/building-parity-between-brand-and-generic-peptide-products-regulatory-and-scientific-considerations-for-quality-of-synthetic-peptides
#18
Larisa C Wu, Fu Chen, Sau L Lee, Andre Raw, Lawrence X Yu
Peptides are a fast growing segment in the pharmaceutical industry. Consequently, the industry and regulatory agencies are increasing their focus on the regulatory path and quality considerations for peptide development and manufacturing. Although most peptides are synthetic, manufactured by solid phase synthesis, nevertheless they are complex molecules with challenging quality and regulatory aspects. This paper provides a structured overview of relevant quality issues for chemically synthesized peptides used as active pharmaceutical ingredients (API) in drug products...
December 24, 2016: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28004346/bioavailability-and-bioequivalence-aspects-of-oral-modified-release-drug-products
#19
Rong Wang, Dale P Conner, Bing V Li
Oral modified-release (MR) products are dosage forms administered through the mouth and designed to release drug in a controlled manner to achieve maximum efficacy, minimal side effects, and better patient compliance. With significant progress in pharmaceutical technologies and favored therapeutic benefit, more and more oral MR products including the generic versions of these products are being developed, marketed, and used in the USA. Because different types of MR products may exhibit unique drug release modes and specific pharmacokinetic profiles, a better understanding of the regulation and evaluation of these generic MR products can help development and marketing of generic MR products that are therapeutically equivalent to the corresponding reference product...
March 2017: AAPS Journal
https://www.readbyqxmd.com/read/27976799/carbamazepine-versus-phenobarbitone-monotherapy-for-epilepsy-an-individual-participant-data-review
#20
REVIEW
Sarah J Nolan, Anthony G Marson, Jennifer Weston, Catrin Tudur Smith
BACKGROUND: This is an updated version of the original Cochrane Review, first published in Issue 1, 2003 and updated in 2015. This review is one in a series of Cochrane Reviews investigating pair-wise monotherapy comparisons.Epilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure-free and go into long-term remission shortly after starting drug therapy with a single antiepileptic drug in monotherapy...
December 15, 2016: Cochrane Database of Systematic Reviews
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