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https://www.readbyqxmd.com/read/29350120/-continued-development-of-drugs-the-path-of-thioguanine
#1
M Simsek, K H N de Boer, C J J Mulder
Continued development of existing drugs ('drug rediscovery') may offer new therapeutic options and be cost-effective. Rediscovered drugs are commonly prescribed off-label, although licensing can be important to allow safe and controlled prescription of the drugs to patients. Licensing of a new indication for a generic drug, however, is a complicated process since there is no blueprint for this and there is little interest from the pharmaceutical industry due to an unattractive cost-recovery model. In this article, we illustrate the successful license-extension for thioguanine - initially developed in 1950 for leukaemia - as a new treatment for patients with inflammatory bowel disease...
2018: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/29343977/cost-effectiveness-analysis-of-six-therapies-for-the-treatment-of-lower-urinary-tract-symptoms-due-to-benign-prostatic-hyperplasia
#2
James C Ulchaker, Melissa S Martinson
Objective: To conduct a cost-effectiveness analysis from payers' perspectives of six treatments for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and to examine positioning of these modalities in the marketplace for the best use of health care funds and quality-of-life benefits for patients. Methods: The economic analysis was conducted with a Markov model to compare combination prescription drug therapy (ComboRx), minimally invasive therapies (MITs) including convective radiofrequency (RF) water vapor thermal therapy (Rezūm®), conductive RF thermal therapy (Prostiva®), and prostatic urethral lift (UroLift®), and invasive surgical procedures including photovaporization of the prostate (Greenlight® PVP) and transurethral resection of the prostate (TURP)...
2018: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/29340562/medicare-spending-and-potential-savings-on-brand-name-drugs-with-available-generic-substitutes-excluded-by-2-large-pharmacy-benefit-managers-2012-through-2015
#3
Alexander C Egilman, Joshua D Wallach, Joseph S Ross, Sanket S Dhruva
No abstract text is available yet for this article.
January 16, 2018: JAMA Internal Medicine
https://www.readbyqxmd.com/read/29339133/antithrombin-iii-binding-site-analysis-of-low-molecular-weight-heparin-fractions
#4
Yin Chen, Jing Zhao, Yanlei Yu, Xinyue Liu, Lei Lin, Fuming Zhang, Robert J Linhardt
Low molecular weight heparins (LMWHs) are widely used as clinical anticoagulant drugs. LMWHs are heterogeneous and highly negatively charged glycans prepared by chemical or enzymatic depolymerization of unfractionated heparin. The detailed structural analysis of a LMWH is essential for the drug quality control. In this study, a LMWH, enoxaparin sodium (a generic version of Lovenox) was separated to different molecular weights fractions by a Superdex peptide column. The disaccharide compositions, 3-O-sulfo group containing tetrasaccharides composition, and antithrombin III binding affinity of the fractions from this LMWH were analyzed...
January 12, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29338273/adverse-drug-reactions-of-non-opioid-and-opioid-analgesics-reported-to-croatian-national-authority-from-2007-to-2014
#5
Petra Sunara, Darko Krnic, Livia Puljak
OBJECTIVE: Adverse drug reactions (ADRs) are commonly observed in the health services because of system weaknesses and individual errors. Analgesics are widely used and it can be expected that with the increased use one can expect increased number of ADRs of analgesics. The aim of this study was to analyze ADRs of non-opioid and opioid analgesics reported to the Croatian Agency for Medicinal Products and Medical Devices (HALMED) from 2007 to 2014. METHODS: HALMED provided data on generic drug name, year of the ADR report, type of report, institution, reporting person, patient's age, sex and ADR type...
November 2017: Acta Medica Academica
https://www.readbyqxmd.com/read/29335085/-impact-of-transition-readiness-on-quality-of-life-in-children-with-chronic-diseases
#6
Jia-Li Ma, Nan Sheng, Wen-Wen Ding, Ying Zhang
OBJECTIVE: To investigate the current quality of life in children with chronic diseases, and to explore the impact of transition readiness on quality of life. METHODS: A total of 332 children with chronic diseases from two children's hospitals in Shanghai, China were enrolled. A self-designed demographic questionnaire, Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQLTM 4.0), and Self-Management and Transition to Adulthood with Rx=Treatment (STARx) Questionnaire were used to evaluate transition readiness and quality of life...
January 2018: Zhongguo Dang Dai Er Ke za Zhi, Chinese Journal of Contemporary Pediatrics
https://www.readbyqxmd.com/read/29331750/phosphoinositide-3-kinase-inhibitors-in-advanced-breast-cancer-a-systematic-review-and-meta-analysis
#7
REVIEW
Jacques Raphael, Danielle Desautels, Kathleen I Pritchard, Ekaterina Petkova, Prakeshkumar S Shah
Phosphoinositide 3-kinase (PI3K) inhibitors may overcome drug resistance and improve advanced breast cancer (ABC) outcomes. We conducted a systematic review and meta-analysis to assess the efficacy and safety of adding a PI3K inhibitor to the standard of care (SOC) treatment in ABC. The electronic databases Ovid, PubMed, Cochrane Central Register of Controlled Trials and Embase, were searched for relevant randomised trials. Pooled hazard ratios (HRs) for progression-free survival (PFS) and pooled risk ratios (RRs) for objective response rates (ORRs), disease control rates (DCRs) and toxicity were meta-analysed using the Mantel-Haenszel method and generic inverse variance...
January 10, 2018: European Journal of Cancer
https://www.readbyqxmd.com/read/29330847/interchangeability-of-generic-drugs-a-non-parametric-pharmacokinetic-model-of-gabapentin-generic-drugs
#8
P J Glerum, Y Yu, W M Yamada, M N Neely, M Maliepaard, D M Burger, C Neef
Substitution by generic drugs is allowed when bioequivalence to the originator drug has been established. However, it is known that similarity in exposure may not be achieved at every occasion for all individual patients when switching between formulations. The ultimate aim of our research is to investigate if pharmacokinetic subpopulations exist when subjects are exposed to bioequivalent formulations. For that purpose, we developed a pharmacokinetic model for gabapentin, based on data from a previously conducted bioavailability study comparing gabapentin exposure following administration of the gabapentin originator and three generic gabapentin formulations in healthy subjects...
January 13, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29329941/analysis-of-refuse-to-file-policy-for-generic-drug-application-in-taiwan
#9
I-Chen Sun, Churn-Shiouh Gau
Generic drugs are accounted for majority of medicinal products. To reduce the unnecessary review for incomplete dossiers of generic drugs, Taiwanese government launched a refuse-to-file (RTF) procedure since 2017. The present study aimed to examine the outcome of RTF procedure by analyzing application characteristic, RTF rate and deficiencies found in the submitted dossiers. Descriptions of administrative information, chemistry, manufacturing and controls, bioequivalence study, and comparative dissolution testing were presented during the first 6 months after the implementation of RTF policy...
January 9, 2018: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29329884/impurity-profiling-of-drug-candidates-analytical-strategies-using-reversed-phase-and-mixed-mode-high-performance-liquid-chromatography-methods
#10
Elise Lemasson, Sophie Bertin, Philippe Hennig, Eric Lesellier, Caroline West
The development of new active pharmaceutical ingredients (API) requires accurate impurity profiling. Nowadays, reversed-phase HPLC (RPLC) on C18 stationary phase is the method of first choice for this task and usually employed in generic screening methods. However, this method sometimes fails, especially when the target analyte is not sufficiently retained, making impurity analysis difficult or even impossible. In such cases, a second method must be available. In the present paper, we compare the merits of RPLC on C18 phase to those of previously optimized alternative methods, based on the analysis of a large and diverse set of small-molecule drug candidates...
January 8, 2018: Journal of Chromatography. A
https://www.readbyqxmd.com/read/29327520/risk-factors-of-clinical-and-immunological-failure-in-south-indian-cohort-on-generic-antiretroviral-therapy
#11
Mucheli Shravan Sadashiv, Priscilla Rupali, Abi Manesh, Rajesh Kannangai, Ooriapadickal Cherian Abraham, Susanne A Pulimood, Rajiv Karthik, S Rajkumar, Kurien Thomas
Background: Since the time of NACO Antiretroviral (ART) roll-out, generic ART has been the mainstay of therapy. There are many studies documenting the efficacy of generic ART but with the passage of time, failure of therapy is on the rise. As institution of second line ART has significant financial implications both for a program and for an individual it is imperative that we determine factors which contribute towards treatment failure in a cohort of patients on generic antiretroviral therapy...
December 2017: Journal of the Association of Physicians of India
https://www.readbyqxmd.com/read/29322918/a-linear-programming-computational-framework-integrates-phosphor-proteomics-and-prior-knowledge-to-predict-drug-efficacy
#12
Zhiwei Ji, Bing Wang, Ke Yan, Ligang Dong, Guanmin Meng, Lei Shi
BACKGROUND: In recent years, the integration of 'omics' technologies, high performance computation, and mathematical modeling of biological processes marks that the systems biology has started to fundamentally impact the way of approaching drug discovery. The LINCS public data warehouse provides detailed information about cell responses with various genetic and environmental stressors. It can be greatly helpful in developing new drugs and therapeutics, as well as improving the situations of lacking effective drugs, drug resistance and relapse in cancer therapies, etc...
December 21, 2017: BMC Systems Biology
https://www.readbyqxmd.com/read/29322654/brand-to-generic-levetiracetam-switching-a-four-years-prospective-observational-real-life-study
#13
Michele Trimboli, Emilio Russo, Laura Mumoli, Giovanni Tripepi, Francesco Fortunato, Giovanni Mastroianni, Francesca Abate, Giovambattista De Sarro, Antonio Gambardella, Angelo Labate
BACKGROUND: The purpose of this study was to determine whether the switching from branded levetiracetam (LEV; ® Keppra) to a LEV generic equivalent product (® Matever) in an epilepsy cohort could result adequate in terms of seizures control and tolerability. METHODS: To be eligible for the study, patients were taking ® Keppra as monotherapy or polytherapy for at least six months. Since March 2013 to April 2017, patients were proposed to switch to ® Matever as part of their follow-up...
January 11, 2018: European Journal of Neurology: the Official Journal of the European Federation of Neurological Societies
https://www.readbyqxmd.com/read/29322470/associations-between-the-drug-burden-index-potentially-inappropriate-medications-and-quality-of-life-in-residential-aged-care
#14
Stephanie L Harrison, Lisa Kouladjian O'Donnell, Clare E Bradley, Rachel Milte, Suzanne M Dyer, Emmanuel S Gnanamanickam, Enwu Liu, Sarah N Hilmer, Maria Crotty
BACKGROUND: Inappropriate polypharmacy may negatively impact the quality of life of residents in aged care facilities, but it remains unclear which medications may influence this reduced quality of life. OBJECTIVE: The objective of this study was to examine whether the Drug Burden Index and potentially inappropriate medications were associated with quality of life in older adults living in residential care with a high prevalence of cognitive impairment and dementia...
January 11, 2018: Drugs & Aging
https://www.readbyqxmd.com/read/29319156/overview-of-the-european-medicines-agency-s-development-of-product-specific-bioequivalence-guidelines
#15
Jane O' Sullivan, Kevin Blake, Michael Berntgen, Tomas Salmonson, Jan Welink
The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms...
December 5, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29317432/in-silico-evaluation-of-pharmacokinetic-optimization-for-antimitogram-based-clinical-trials
#16
Skerdi Haviari, Benoît You, Michel Tod
Antimitograms are prototype in vitro tests for evaluating chemotherapeutic efficacy using patient-derived primary cancer cells. These tests might help optimize treatment from a pharmacodynamic (PD) standpoint by guiding treatment selection. However, they are technically challenging and require refinements and trials to demonstrate benefit in order to be widely used. In this study, we performed simulations aimed at exploring how to validate antimitograms and how to complement them by pharmacokinetic (PK) optimization...
January 9, 2018: Cancer Research
https://www.readbyqxmd.com/read/29316910/determinants-of-new-drugs-prescription-in-the-swiss-healthcare-market
#17
Anne Decollogny, Romain Piaget-Rossel, Patrick Taffé, Yves Eggli
BACKGROUND: Drug markets are very complex and, while many new drugs are registered each year, little is known about what drives the prescription of these new drugs. This study attempts to lift the veil from this important subject by analyzing simultaneously the impact of several variables on the prescription of novelty. METHODS: Data provided by four Swiss sickness funds were analyzed. These data included information about more than 470,000 insured, notably their drug intake...
January 9, 2018: BMC Health Services Research
https://www.readbyqxmd.com/read/29315859/medical-and-economic-factors-influencing-generic-drug-use-in-the-japanese-public-health-system-influencing-factors-in-different-populations
#18
Tomoya Tachi, Kosuke Saito, Hiroki Esaki, Yuta Kanematsu, Aki Yoshida, Ikuto Sugita, Yoshihiro Noguchi, Teppei Makino, Michi Umeda, Masahiro Yasuda, Takashi Mizui, Chitoshi Goto, Hitomi Teramachi
Factors influencing generic drug use must be considered when new drug policies are established and initiatives are implemented to promote generic drug use. This study was conducted to elucidate medical and economic factors that influence generic drug use in the Japanese public health system by evaluating the degree of generic drug use via a multivariate analysis. We conducted a retrospective study of medications administered to inpatients at Gifu Municipal Hospital (Japan) from November 1 to 14, 2014. Details of inpatients (age, sex, and type of medical insurance) and the drugs administered (prescribing institution, dispensing pharmacy, price, and class) were assessed...
January 8, 2018: International Journal of Health Planning and Management
https://www.readbyqxmd.com/read/29314750/phase-i-metabolism-of-the-recently-emerged-synthetic-cannabinoid-cumyl-pegaclone-and-detection-in-human-urine-samples
#19
Lukas Mogler, Maurice Wilde, Laura M Huppertz, Georg Weinfurtner, Florian Franz, Volker Auwärter
Indole, indazole or azaindole based synthetic cannabinoids (SCs), bearing a cumyl substituent are a widespread, recreationally used subgroup of new psychoactive substances (NPS). The latest cumyl-derivative, CUMYL-PEGACLONE, emerged in December 2016 on the German drug market. The substance features a novel γ-carboline core structure, which is most likely synthesized to bypass generic legislative approaches to control SCs by prohibiting distinct core structures. Using liquid chromatography tandem mass spectrometry and liquid chromatography high resolution mass spectrometry techniques, the main in vivo phase I metabolites of this new substance were detected...
January 3, 2018: Drug Testing and Analysis
https://www.readbyqxmd.com/read/29313311/the-safety-of-generic-prescription-drugs-in-the-united-states
#20
Sonal Singh
No abstract text is available yet for this article.
January 8, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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