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Efficacy of generic drugs

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https://www.readbyqxmd.com/read/27913991/24-hour-efficacy-and-ocular-surface-health-with-preservative-free-tafluprost-alone-and-in-conjunction-with-preservative-free-dorzolamide-timolol-fixed-combination-in-open-angle-glaucoma-patients-insufficiently-controlled-with-preserved-latanoprost-monotherapy
#1
Anastasios-Georgios Konstas, Konstadinos G Boboridis, Paraskevas Kapis, Konstantinos Marinopoulos, Irini C Voudouragkaki, Dimitrios Panayiotou, Dimitrios G Mikropoulos, Eirini Pagkalidou, Anna-Bettina Haidich, Andreas Katsanos, Luciano Quaranta
INTRODUCTION: The aim of the present study was to evaluate the 24-h efficacy, tolerability, and ocular surface health with preservative-free (PF) tafluprost and a PF triple drug regimen comprising tafluprost and dorzolamide/timolol fixed combination (DTFC) in open-angle glaucoma patients who were insufficiently controlled with preserved branded or generic latanoprost monotherapy and who exhibited signs or symptoms of ocular surface disease (OSD). METHODS: Prospective, observer-masked, crossover, comparison...
December 2, 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27911675/on-safety-margin-for-drug-interchangeability
#2
Jiayin Zheng, Shein-Chung Chow, Fuyu Song
As more and more generic (or biosimilar) drug products become available in the market place, it is a concern whether the approved generic (or biosimilar) drug products are safe and efficacious and hence can be used interchangeably. According to current regulation, most regulatory agencies such as the United States Food and Drug Administration (FDA) indicate an approved generic (or biosimilar) drug product can serve as a substitute for the innovative drug product. Bioequivalence (biosimilarity) assessment for regulatory approval among generic copies (or biosimilars) of the innovative drug product are not required...
December 2, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27907869/is-a-deuterated-internal-standard-appropriate-for-the-reliable-determination-of-olmesartan-in-human-plasma
#3
Edyta Piórkowska, Jacek Musijowski, Katarzyna Buś-Kwaśnik, Piotr J Rudzki
A right choice of the internal standard is one of the most challenging tasks during bioanalytical method development. Surprisingly, among the HPLC-MS methods for the determination of a cardiovascular drug olmesartan in plasma only structural analogues or similar compounds were used as internal standards. We have tried to answer the question whether the stable isotope labelled (deuterated) internal standard, as recommended by regulatory agencies, can be used for the reliable determination of olmesartan in human plasma...
November 16, 2016: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/27895236/a-review-of-single-tablet-regimens-for-the-treatment-of-hiv-1-infection
#4
REVIEW
Jamielynn C Sebaaly, Denise Kelley
OBJECTIVE: To review the pharmacokinetics, safety, drug-drug interactions, and advantages and disadvantages of currently available single-tablet regimens (STRs) for HIV-1 infection. DATA SOURCES: A search using PubMed was conducted (up to September 2016) using the following keywords: single tablet regimen AND HIV Additionally, a PubMed search was conducted for each individual STR using the generic names of the agents. Articles were evaluated for content, and additional references were identified from a review of literature citations...
November 27, 2016: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/27886163/alghedon-fentanyl-transdermal-system-afts
#5
Patrizia Romualdi, Patrizia Santi, Sanzio Candeletti
The efficacy of transdermal fentanyl for cancer pain and chronic non-cancer pain (chronic lower back pain, rheumatoid arthritis, osteoarthritis, neuropathic pain) is well established. Several formulations of fentanyl transdermal systems have been developed to improve the drug delivery and prevent misuse of the active principle. The addition of a rate controlling membrane to the matrix system represented an important advance. The design and functional features of Alghedon patch are compared with other approved generic fentanyl transdermal systems, emphasizing the distinctiveness of Alghedon patch...
November 25, 2016: Minerva Medica
https://www.readbyqxmd.com/read/27809755/multi-particulate-systems-cutting-edge-technology-for-controlled-drug-delivery
#6
Sarika Wairkar, Ram Gaud, Adhithi Raghavan
BACKGROUND: In the last two decades, multi-particulate dosage forms have caught the attention of formulation scientists due to their tremendous potential as a drug delivery system with a broad range of applications. METHODS: Recent patented technologies are focused on designing multi-particulate systems that can enhance therapeutic efficacy and oral bioavailability with minimum systemic toxicity. The technologies offer opportunities to the manufacturers for increasing their market share, especially for competitive generics, and also establishing intellectual property positions...
November 3, 2016: Recent Patents on Drug Delivery & Formulation
https://www.readbyqxmd.com/read/27798876/bioequivalence-of-branded-and-generic-oxaliplatin-from-preclinical-assessment-to-clinical-incidence-of-hypersensitivity-reactions
#7
Marco Tampellini, Simone Benedetto, Elena Rubatto, Chiara Baratelli, Federica DI Scipio, Elisa Pirro, Maria Pia Brizzi, Cristina Sonetto, Massimo DI Maio, Giovanni Nicolao Berta, Giorgio Vittorio Scagliotti
BACKGROUND: Generic anticancer drugs represent an opportunity in terms of cost savings but there are some concerns about their tolerability. The safety profiles of generic versus branded oxaliplatin formulations have never been studied in detail. PATIENTS AND METHODS: We tested in vitro concentrations, stability and efficacy of branded versus generic oxaliplatin formulations, then we retrospectively collected data about hypersensitivity reactions (HSR) of 427 colorectal cancer patients treated with oxaliplatin-based regimens...
October 2016: Anticancer Research
https://www.readbyqxmd.com/read/27790457/in-vitro-comparison-of-generic-and-branded-preparations-of-amoxicillin-with-potassium-clavulanate
#8
Priyanka Pathak, Jayshree Dawane
INTRODUCTION: The Medical Council of India (MCI) has guidelines for physicians to prescribe drugs with generic names. But physicians and patients might have prejudices against generic drug substitution or concerns regarding quality and generics effectiveness. If the drugs are ineffective, they can result in adverse clinical outcomes such as treatment failure. According to WHO, β-lactams are the most common substandard drugs to be produced amongst antibiotics. AIM: To evaluate and compare invitro efficacy of generic and branded preparations of Amoxicillin with Potassium Clavulanate...
September 2016: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/27764025/use-of-therapeutic-drug-monitoring-electronic-health-record-data-and-pharmacokinetic-modeling-to-determine-the-therapeutic-index-of-phenytoin-and-lamotrigine
#9
Lawrence C Ku, Huali Wu, Rachel G Greenberg, Kevin D Hill, Daniel Gonzalez, Christoph P Hornik, Alysha Berezny, Jeffrey T Guptill, Wenlei Jiang, Nan Zheng, Michael Cohen-Wolkowiez, Chiara Melloni
BACKGROUND: Defining a drug's therapeutic index (TI) is important for patient safety and regulating the development of generic drugs. For many drugs, the TI is unknown. A systematic approach was developed to characterize the TI of a drug using therapeutic drug monitoring and electronic health record (EHR) data with pharmacokinetic (PK) modeling. This approach was first tested on phenytoin, which has a known TI, and then applied to lamotrigine, which lacks a defined TI. METHODS: Retrospective EHR data from patients in a tertiary hospital were used to develop phenytoin and lamotrigine population PK models and to identify adverse events (anemia, thrombocytopenia, and leukopenia) and efficacy outcomes (seizure-free)...
December 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/27736953/projected-uptake-of-new-antiretroviral-arv-medicines-in-adults-in-low-and-middle-income-countries-a-forecast-analysis-2015-2025
#10
Aastha Gupta, Sandeep Juneja, Marco Vitoria, Vincent Habiyambere, Boniface Dongmo Nguimfack, Meg Doherty, Daniel Low-Beer
With anti-retroviral treatment (ART) scale-up set to continue over the next few years it is of key importance that manufacturers and planners in low- and middle-income countries (LMICs) hardest hit by the HIV/AIDS pandemic are able to anticipate and respond to future changes to treatment regimens, generics pipeline and demand, in order to secure continued access to all ARV medicines required. We did a forecast analysis, using secondary WHO and UNAIDS data sources, to estimate the number of people living with HIV (PLHIV) and the market share and demand for a range of new and existing ARV drugs in LMICs up to 2025...
2016: PloS One
https://www.readbyqxmd.com/read/27736789/effects-of-in-feed-chlortetracycline-prophylaxis-in-beef-cattle-on-animal-health-and-antimicrobial-resistant-escherichia-coli
#11
Getahun E Agga, John W Schmidt, Terrance M Arthur
: Concerns have been raised that in-feed chlortetracycline (CTC) may increase antimicrobial resistance (AMR), specifically tetracycline-resistant (TET(r)) Escherichia coli and third-generation cephalosporin-resistant (3GC(r)) E. coli We evaluated the impact of a 5-day in-feed CTC prophylaxis on animal health, TET(r) E. coli, and 3GC(r) E. coli A control group of cattle (n = 150) received no CTC, while a CTC group (n = 150) received in-feed CTC (10 mg/lb of body weight/day) from the 5th to the 9th day after feedlot arrival...
December 15, 2016: Applied and Environmental Microbiology
https://www.readbyqxmd.com/read/27672407/molecular-insights-into-fully-human-and-humanized-monoclonal-antibodies-what-are-the-differences-and-should-dermatologists-care
#12
Lotus Mallbris, Julian Davies, Andrew Glasebrook, Ying Tang, Wolfgang Glaesner, Brian J Nickoloff
In recent years, a large number of therapeutic monoclonal antibodies have come to market to treat a variety of conditions including patients with immune-mediated chronic inflammation. Distinguishing the relative clinical efficacy and safety profiles of one monoclonal antibody relative to another can be difficult and complex due to different clinical designs and paucity of head-to-head comparator studies. One distinguishing feature in interpreting clinical trial data by dermatologists may begin by determining whether a monoclonal antibody is fully human or humanized, which can be discerned by the generic name of the drug...
July 2016: Journal of Clinical and Aesthetic Dermatology
https://www.readbyqxmd.com/read/27610084/current-status-of-the-new-antiepileptic-drugs-in-chronic-pain
#13
REVIEW
Harpreet S Sidhu, Akshay Sadhotra
Antiepileptic drugs (AEDs) are extensively used worldwide to treat a wide range of disorders other than epilepsy, such as neuropathic pain, migraine, and bipolar disorder. Due to this situation more than 20 new third-generation AEDs have been introduced in the market recently. The future design of new AEDs must also have potential to help in the non-epileptic disorders. The wide acceptance of second generation AEDs for the management of various non-epileptic disorders has caused the emergence of generics in the market...
2016: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/27601883/very-rapid-virologic-response-and-early-hcv-response-kinetics-as-quick-measures-to-compare-efficacy-and-guide-a-personalized-response-guided-therapy
#14
Mostafa Yakoot, Alaa M Abdo, Ahmed Yousry, Sherine Helmy
BACKGROUND: This is the second and final report for our study designed to compare two generic sofosbuvir products for the degree and speed of virologic response to a dual anti-hepatitis C virus (HCV) treatment protocol. We aimed to test the applicability of the early virus response kinetics and the very rapid virologic response (vRVR) rate as quick outcome measures for accelerated comparative efficacy studies and as a foundation for a personalized response-guided therapy. METHODS: Fifty eligible chronic HCV patients were randomized to either one of two generic sofosbuvir products (Gratisovir or Grateziano) at a daily dose of one 400 mg tablet plus a weight-based ribavirin dose...
2016: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/27591130/do-national-drug-policies-influence-antiretroviral-drug-prices-evidence-from-the-southern-african-development-community
#15
Yao Liu, Omar Galárraga
BACKGROUND: The efficacy of low- and middle-income countries' (LMIC) national drug policies in managing antiretroviral (ARV) pharmaceutical prices is not well understood. Though ARV drug prices have been declining in LMIC over the past decade, little research has been done on the role of their national drug policies. This study aims to (i) analyse global ARV prices from 2004 to 2013 and (ii) examine the relationship of national drug policies to ARV prices. METHODS: Analysis of ARV drug prices utilized data from the Global Price Reporting Mechanism from the World Health Organization (WHO)...
September 1, 2016: Health Policy and Planning
https://www.readbyqxmd.com/read/27580358/dexlansoprazole-delayed-release-orally-disintegrating-tablets-for-the-treatment-of-heartburn-associated-with-non-erosive-gastroesophageal-reflux-disease-and-the-maintenance-of-erosive-esophagitis
#16
Edward C Oldfield Iv, Parth J Parekh, David A Johnson
INTRODUCTION: Gastroesophageal reflux disease (GERD) is a common clinical condition afflicting millions of patients, whose prevalence continues to rise owing to the aging population and increasing burden of comorbid conditions, such as obesity. Currently, the mainstay of therapy for GERD is treatment with proton pump inhibitors (PPIs). Despite their overall efficacy, safety, and tolerability, there are still a considerable number of patients who fail treatment and have refractory symptoms to PPI therapy...
August 31, 2016: Expert Review of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/27576318/bioavailability-efficacy-and-safety-of-generic-immunosuppressive-drugs-for-kidney-transplantation-a-systematic-review-and-meta-analysis
#17
Evangelos Tsipotis, Navin R Gupta, Gowri Raman, Elias Zintzaras, Bertrand L Jaber
BACKGROUND: Concerns exist over the extrapolation of bioavailability studies of generic immunosuppressive drugs in healthy volunteers, regarding their efficacy and safety in kidney transplant recipients. We conducted a meta-analysis of trials examining the bioavailability of generic (test) immunosuppressive drugs relative to their brand (reference) counterparts in healthy volunteers, based on the US Food and Drug Administration requirements for approval of generics, and their efficacy and safety in kidney transplant recipients...
2016: American Journal of Nephrology
https://www.readbyqxmd.com/read/27574988/medicinal-product-regulation-portugal-s-framework
#18
Maria Teresa Herdeiro, Paulo D Bastos, António Teixeira-Rodrigues, Fátima Roque
PURPOSE: The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED)...
September 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27556048/emerging-technologies-and-generic-assays-for-the-detection-of-anti-drug-antibodies
#19
REVIEW
Michael A Partridge, Shobha Purushothama, Chinnasamy Elango, Yanmei Lu
Anti-drug antibodies induced by biologic therapeutics often impact drug pharmacokinetics, pharmacodynamics response, clinical efficacy, and patient safety. It is critical to assess the immunogenicity risk of potential biotherapeutics in producing neutralizing and nonneutralizing anti-drug antibodies, especially in clinical phases of drug development. Different assay methodologies have been used to detect all anti-drug antibodies, including ELISA, radioimmunoassay, surface plasmon resonance, and electrochemiluminescence-based technologies...
2016: Journal of Immunology Research
https://www.readbyqxmd.com/read/27524685/synthesis-characterization-and-monoamine-transporter-activity-of-the-new-psychoactive-substance-mexedrone-and-its-n-methoxy-positional-isomer-n-methoxymephedrone
#20
Gavin McLaughlin, Noreen Morris, Pierce V Kavanagh, John D Power, Geraldine Dowling, Brendan Twamley, John O'Brien, Brian Talbot, Donna Walther, John S Partilla, Michael H Baumann, Simon D Brandt
3-Methoxy-2-(methylamino)-1-(4-methylphenyl)propan-1-one (mexedrone) appeared in 2015 and was advertised by UK Internet retailers as a non-controlled mephedrone derivative (2-(methylamino)-1-(4-methylphenyl)propan-1-one), which was of particular interest to countries who operate generic drugs legislation. This study describes the synthesis and analytical characterization of mexedrone and differentiation from its isomer, N-methoxymephedrone, which was predicted to be a suitable candidate before the identity of mexedrone was revealed...
August 15, 2016: Drug Testing and Analysis
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