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https://www.readbyqxmd.com/read/29149162/-switching-from-one-drug-therapy-to-another-with-the-same-therapeutic-indication-without-harms
#1
Valeria Belleudi, Antonio Addis
The loss of exclusivity from several drug therapies largely used bring new attention the issues of safety, efficacy and following the switch from one drug to another (i.e., biosimilar and/or generics) with the same indication. This is not a problem that can be related to regulatory or economical factors. The increase of patients exposed to chronic conditions and the introductions or more pharmaceutical alternatives with same therapeutic indications yield for studies able to verify the effectiveness and safety even when switch from more drugs is considered by practitioners...
November 2017: Recenti Progressi in Medicina
https://www.readbyqxmd.com/read/29149148/current-impact-and-application-of-abuse-deterrent-opioid-formulations-in-clinical-practice
#2
Ya-Han Lee, Daniel L Brown, Hsiang-Yin Chen
BACKGROUND: Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse. OBJECTIVE: We aim to compare and contrast the characteristics and applications of current abuse-deterrent opioid products in clinical practice. METHODS: Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations...
November 2017: Pain Physician
https://www.readbyqxmd.com/read/29144957/fluconazole-levels-in-serum-and-cerebrospinal-fluid-according-to-daily-dosage-in-patients-with-cryptococcosis-and-other-fungal-infections
#3
Letícia Aparecida Schiave, Erika Nascimento, Fernando Crivelenti Vilar, Tissiana Marques de Haes, Osvaldo Massaiti Takayanagui, Cristiane Masetto de Gaitani, Roberto Martinez
Fluconazole is extensively used for the treatment of candidiasis and cryptococcosis. Among other factors, successful treatment is related to appropriate fluconazole levels in blood and cerebrospinal fluid (CSF). In the present study, fluconazole levels were determined in 15 patients, 14 of whom had AIDS and 13 had neurocryptococcosis. The only selection criterion was treatment with fluconazole, which was performed with a generic or similar form of the drug. Fluconazole level was determined by high performance liquid chromatography and the susceptibility profile of Cryptococcus spp...
November 13, 2017: Brazilian Journal of Infectious Diseases
https://www.readbyqxmd.com/read/29142086/shortage-of-generic-neurologic-therapeutics-an-escalating-threat-to-patient-care
#4
Jacklyn O Omorodion, Rami M Algahtani, Mark S Zocchi, Erin R Fox, Jesse M Pines, Henry J Kaminski
OBJECTIVE: To assess longitudinal trends in shortages of generic drugs used for neurologic conditions over a 15-year period in the United States. METHODS: Drug shortage data from the University of Utah Drug Information Service (UUDIS) from 2001 to 2015 were analyzed. Medications were included that were likely to be prescribed by a neurologist to treat a primary neurologic condition or critical for care of a patient with a neurologic condition. Trends in shortage length were assessed using standard descriptive statistics...
November 15, 2017: Neurology
https://www.readbyqxmd.com/read/29139187/pharmacokinetics-and-safety-of-paclitaxel-delivery-into-porcine-airway-walls-by-a-new-endobronchial-drug-delivery-catheter
#5
Hisashi Tsukada, Plamena Entcheva-Dimitrov, Armin Ernst, Samaan Rafeq, John H Keating, Kirk P Seward, Lonny Yarmus
BACKGROUND AND OBJECTIVE: Intratumoral administration of chemotherapeutic agents is a treatment modality that has proven efficacious in reducing the recurrence of tumours and increases specificity of treatment while minimizing systemic side effects. Direct intratumoral injection of malignant airway obstruction has potential therapeutic benefits but tissue drug concentrations and side-effect profiles are poorly understood. METHODS: Bronchial wall injection of generic paclitaxel (PTX) (102 injections of 0...
November 14, 2017: Respirology: Official Journal of the Asian Pacific Society of Respirology
https://www.readbyqxmd.com/read/29138377/-safety-evaluation-of-paclitaxel-injection-nk-in-tri-weekly-administration-of-paclitaxel-plus-carboplatin-tc-therapy-for-gynecological-cancers
#6
Takashi Ikeda, Iori Kisu, Yasunori Sakamoto
Paclitaxel is a key drug used for the treatment of gynecological cancers, breast cancer, and gastric cancer. While there is a great deal of safety information on the weekly administration of generic paclitaxel NK(paclitaxel injection NK)and proprietary paclitaxel(Taxol®injection), little is known about their safety when administered tri-weekly, partly due to a small sample size. Therefore, to gain more information and to validate the safety of using generic paclitaxel NK in a tri-weekly regimen, we investigated the incidences of adverse events in response to it in a larger number of patients...
November 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/29135993/bioequivalence-between-innovator-and-generic-tacrolimus-in-liver-and-kidney-transplant-recipients-a-randomized-crossover-clinical-trial
#7
Rita R Alloway, Alexander A Vinks, Tsuyoshi Fukuda, Tomoyuki Mizuno, Eileen C King, Yuanshu Zou, Wenlei Jiang, E Steve Woodle, Simon Tremblay, Jelena Klawitter, Jost Klawitter, Uwe Christians
BACKGROUND: Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, "brand") product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29135980/bioequivalence-of-twice-daily-oral-tacrolimus-in-transplant-recipients-more-evidence-for-consensus
#8
Simon Ball
In this Perspective on the clinical trial by Rita Alloway and colleagues, Simon Ball explains the benefits to healthcare systems and individual patients of the bioequivalence established between generic and brand-name formulations of an immunosuppressive drug in transplant recipients.
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29129935/antimalarial-use-of-malagasy-plants-is-poorly-correlated-with-performance-in-antimalarial-bioassays
#9
Wendy L Applequist, Michel Ratsimbason, Alyse Kuhlman, Stephan Rakotonandrasana, Vincent Rasamison, David G I Kingston
Bioassay screening of plant extracts can identify unique lead compounds for drug development, but the "hit rate" from random screening is very low. Targeted screening of medicinal plants has been repeatedly reported to increase the percentage of samples displaying bioactivity. Contrarily, Maranz (2012) suggested that African antimalarial plants were unsuitable sources of antimalarial drugs because high prevalence of malaria would result in rapid evolution of resistance to active compounds that directly targeted the parasite...
March 2017: Economic Botany
https://www.readbyqxmd.com/read/29122813/american-heart-association-principles-on-the-accessibility-and-affordability-of-drugs-and-biologics-a-presidential-advisory-from-the-american-heart-association
#10
REVIEW
Elliott M Antman, Mark A Creager, Steven R Houser, John J Warner, Madeleine Konig
Net US spending on pharmaceuticals reached $309.5 billion in 2015, an 8.5% increase from the year before, and is expected to reach between $370 and $400 billion by 2020. These current and projected levels have raised serious concerns by policy makers, providers, payers, and patient groups that they are unsustainable and threaten the affordability of and accessibility to much-needed therapies for patients. Two trends related to drugs/biologics and generic drugs/biosimilars underlie this overall increase in spending...
November 9, 2017: Circulation
https://www.readbyqxmd.com/read/29121918/-no-generics-doctor-the-perspective-of-general-practitioners-in-two-french-regions
#11
Béatrice Riner, Adèle Bussy, Jeannie Hélène-Pelage, Nycrees Moueza, Sébastien Lamy, Philippe Carrère
BACKGROUND: Generic medicines are essential to controlling health expenditures. Their market share is still small in France. The discourse and practices of prescribers may play a major role in their use. The purpose of this study was to explore the knowledge, attitudes and practices of general practitioners (GPs) toward generic medicines in two French regions with the lowest penetration rate of these products. METHODS: An observational study was carried out from October 2015 to February 2016 in Guadeloupe and Martinique...
November 9, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/29120716/cost-comparison-of-commonly-used%C3%A2-postoperative-topical-ophthalmic%C3%A2-antibiotics
#12
Eric L Crowell, Vivek A Koduri, R Scott Groat, David A Lee
PURPOSE: To provide information on the actual fill level and cost of currently available antibiotic drops used perioperatively. DESIGN: Prospective laboratory investigation. SETTING: Robert Cizik Eye Clinic, Houston, Texas USA. METHODS: The following 9 medications were tested: moxifloxacin, gatifloxacin (branded and generic), besifloxacin, levofloxacin, ciprofloxacin, ofloxacin, trimethoprim/polymyxin B, tobramycin, and gentamicin...
October 2017: Journal of Cataract and Refractive Surgery
https://www.readbyqxmd.com/read/29114561/awareness-about-rational-use-of-medicines-among-fresh-bachelor-of-medicine-and-bachelor-of-surgery-graduates
#13
Vijaya Laxman Chaudhari, Smita N Mali, Amruta V Dawari, Tushar B Nishandar
CONTEXT: Fresh Bachelor of Medicine and Bachelor of Surgery graduates (FMGs) are responsible for the majority of prescription errors and irrational use of medicines. Little research has explored their knowledge on rational prescribing practices. AIMS: The present study aimed to evaluate the awareness of rational use of medicines (RUMs) among the FMGs. SETTINGS AND DESIGN: A multicentric, cross-sectional, and questionnaire-based study was conducted among 308 FMGs during the internship orientation program...
2017: Journal of Education and Health Promotion
https://www.readbyqxmd.com/read/29111437/a-new-reliable-transposable-and-cost-effective-assay-for-absolute-quantification-of-total-plasmatic-bevacizumab-by-lc-ms-ms-in-human-plasma-comparing-two-internal-standard-calibration-approaches
#14
Rachel Legeron, Fabien Xuereb, Stephane Chaignepain, Alain-Pierre Gadeau, Stephane Claverol, Jean-William Dupuy, Sarah Djabarouti, Thierry Couffinhal, Jean-Marie Schmitter, Dominique Breilh
The quantification of monoclonal antibodies (mAbs) such as bevacizumab, a recombinant humanized immunoglobulin G1 (hIgG1), in biological fluids, is an essential prerequisite to any pharmacokinetic preclinical and clinical study. To date, reference techniques used to quantify mAbs rely on enzyme-linked immunosorbent assay (ELISA) lacking specificity. Furthermore, the commercially available ELISA kit to quantify bevacizumab in human plasma only assesses the free fraction of the drug. However, the conditions of storage and analysis of plasma samples could alter the physiological equilibrium between the free, bound and partially bound forms of bevacizumab and this could result in over- or underestimation of drug concentration...
October 23, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/29110842/patient-reported-outcome-measures-proms-in-the-management-of-lung-cancer-a-systematic-review
#15
REVIEW
Youssef Ben Bouazza, Ibrahim Chiairi, Ouiam El Kharbouchi, Lesley De Backer, Greetje Vanhoutte, Annelies Janssens, Jan P Van Meerbeeck
Lung cancer is often associated with a poor quality of life, as reflected by patient-reported outcome measures (PROMs). The aim of this paper is to describe and compare the PROMs that are available. In this manuscript, we review the impact of PROMs on the management of lung cancer. Quality of the study and risk of bias were assessed using the appraisal tools recommended by the Dutch Cochrane Center. Out of 51 studies included in this review, ten instruments were identified and categorized as either generic, cancer- or lung cancer-specific...
November 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/29110294/chemometric-methods-to-quantify-1d-and-2d-nmr-spectral-differences-among-similar-protein-therapeutics
#16
Kang Chen, Junyong Park, Feng Li, Sharadrao M Patil, David A Keire
NMR spectroscopy is an emerging analytical tool for measuring complex drug product qualities, e.g., protein higher order structure (HOS) or heparin chemical composition. Most drug NMR spectra have been visually analyzed; however, NMR spectra are inherently quantitative and multivariate and thus suitable for chemometric analysis. Therefore, quantitative measurements derived from chemometric comparisons between spectra could be a key step in establishing acceptance criteria for a new generic drug or a new batch after manufacture change...
November 6, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/29107620/lacking-quality-in-research-is-behavioral-neuroscience-affected-more-than-other-areas-of-biomedical-science
#17
Anton Bespalov, Thomas Steckler
There are many reasons why novel therapeutics fail in clinical trials but these failures are often attributed to lacking quality of preclinical data. These problems are not limited to any specific therapeutic area, academic or industrial research and are due in large part to several generic factors influencing research quality (e.g., related to definition of pre-specified endpoints, principles of study design and analysis, biased reporting, and lack of proper training). Yet, Neuroscience drug discovery is often said to be affected more than the other fields...
October 28, 2017: Journal of Neuroscience Methods
https://www.readbyqxmd.com/read/29107048/beyond-q1-q2-the-impact-of-manufacturing-conditions-and-test-methods-on-drug-release-from-plga-based-microparticle-depot-formulations
#18
John Garner, Sarah Skidmore, Haesun Park, Kinam Park, Stephanie Choi, Yan Wang
Drug-loaded polymeric microparticles have been used as long-acting injectable (LAI) depot formulations. To obtain FDA approval, a generic LAI depot product needs to be qualitatively (Q1) and quantitatively (Q2) the same in terms of inactive ingredients as its reference listed drug (RLD). However, Q1/Q2 sameness as the RLD does not guarantee the same in vitro drug release profile and in vivo performance, especially when the manufacturing methods are different. There is little consensus on how the in vitro testing needs to be done to examine the release profiles of LAI depot formulations...
October 26, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29103339/lesinurad-for-the-treatment-of-hyperuricaemia-in-people-with-gout
#19
Philip C Robinson, Nicola Dalbeth
Gout is a common form of inflammatory arthritis caused by deposition of monosodium urate crystals. The central strategy for effective long-term management of gout is serum urate lowering. Current urate-lowering drugs include both xanthine oxidase inhibitors and uricosuric agents. Lesinurad is a URAT1 inhibitor that selectively inhibits urate rebsorption at the proximal renal tubule. Lesinurad 200mg daily in combination with a xanthine oxidase is approved for urate-lowering therapy in patients with gout. Areas covered: The published literature was searched using Pubmed and additional information was obtained from publically available regulatory documents...
November 6, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29101617/quality-of-medication-information-in-discharge-summaries-from-hospitals-an-audit-of-electronic-patient-records
#20
Beate Hennie Garcia, Berit Svendsen Djønne, Frode Skjold, Ellen Marie Mellingen, Trine Iversen Aag
Background Low quality of medication information in discharge summaries from hospitals may jeopardize optimal therapy and put the patient at risk for medication errors and adverse drug events. Objective To audit the quality of medication information in discharge summaries and explore factors associated with the quality. Setting Helgelandssykehuset Mo i Rana, a rural hospital in central Norway. Method For each month in 2013, we randomly selected 60 discharge summaries from the Department of Medicine and Surgery (totally 720) and evaluated the medication information using eight Norwegian quality criteria...
December 2017: International Journal of Clinical Pharmacy
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