keyword
MENU ▼
Read by QxMD icon Read
search

generics drugs AND quality

keyword
https://www.readbyqxmd.com/read/28431584/monitoring-quality-and-coverage-of-harm-reduction-services-for-people-who-use-drugs-a-consensus-study
#1
Lucas Wiessing, Marica Ferri, Vendula Běláčková, Patrizia Carrieri, Samuel R Friedman, Cinta Folch, Kate Dolan, Brian Galvin, Peter Vickerman, Jeffrey V Lazarus, Viktor Mravčík, Mirjam Kretzschmar, Vana Sypsa, Ana Sarasa-Renedo, Anneli Uusküla, Dimitrios Paraskevis, Luis Mendão, Diana Rossi, Nadine van Gelder, Luke Mitcheson, Letizia Paoli, Cristina Diaz Gomez, Maitena Milhet, Nicoleta Dascalu, Jonathan Knight, Gordon Hay, Eleni Kalamara, Roland Simon, Catherine Comiskey, Carla Rossi, Paul Griffiths
BACKGROUND AND AIMS: Despite advances in our knowledge of effective services for people who use drugs over the last decades globally, coverage remains poor in most countries, while quality is often unknown. This paper aims to discuss the historical development of successful epidemiological indicators and to present a framework for extending them with additional indicators of coverage and quality of harm reduction services, for monitoring and evaluation at international, national or subnational levels...
April 22, 2017: Harm Reduction Journal
https://www.readbyqxmd.com/read/28425236/predictors-of-health-related-quality-of-life-in-childhood-epilepsy-and-comparison-with-healthy-children-findings-from-an-indian-study
#2
Dipika Bansal, Chandrika Azad, Kapil Gudala, Anil Dasari
BACKGROUND/AIM: Children with epilepsy have reduced health-related quality of life (HRQOL) due to disease and medications. We aimed to assess child-reported HRQOL in Indian children with epilepsy and compare it with that in healthy children. MATERIALS AND METHODS: A cross-sectional study of 256 children with epilepsy aged between 5 and 18 years on antiepileptic drug (AED) treatment for at least 3 months was performed and 125 age and sex matched healthy children were included...
April 18, 2017: Turkish Journal of Medical Sciences
https://www.readbyqxmd.com/read/28416417/in-vitro-evaluation-of-nasogastric-ng-tube-delivery-performance-of-esomeprazole-magnesium-delayed-release-capsules
#3
Alicia Hoover, Dajun Sun, Hong Wen, Wenlei Jiang, Minglei Cui, Xiaojian Jiang, David Keire, Changning Guo
Enteral feeding tubes are used to deliver food or drugs to patients that cannot swallow. To deliver delayed-release drugs that are formulated as enteric coated granules to these patients via feeding tubes requires that they be suspended in water prior to administration. Importantly, the suspension of enteric granules in water of varying pH can cause damage to the enteric coating and affect the bioavailability of the drug. Here, analytical methods for testing acid resistance stability and particle size distribution (PSD) of esomeprazole granules were utilized to monitor the integrity of the granule enteric coating after water pretreatment and delivery through an oral syringe and nasogastric (NG) tube...
April 14, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28408012/comparing-generic-and-condition-specific-preference-based-measures-in-epilepsy-eq-5d-3l-and-newqol-6d
#4
COMPARATIVE STUDY
Brendan Mulhern, Joshua Pink, Donna Rowen, Simon Borghs, Thomas Butt, Dyfrig Hughes, Antony Marson, John Brazier
BACKGROUND: There is debate about the psychometric characteristics of the three-level EuroQol five-dimensional questionnaire (EQ-5D-3L) for use in epilepsy. In response to the concerns, an epilepsy-specific preference-based measure (NEWQOL-6D) was developed. The psychometric characteristics of the NEWQOL-6D, however, have not been assessed. OBJECTIVES: To investigate the validity and responsiveness of the EQ-5D-3L and the Quality of Life in Newly Diagnosed Epilepsy Instrument-six dimensions (NEWQOL-6D) for use in the assessment of treatments for newly diagnosed focal epilepsy...
April 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28392910/drug-shortages-in-israel-regulatory-perspectives-challenges-and-solutions
#5
Eyal Schwartzberg, Denize Ainbinder, Alla Vishkauzan, Ronni Gamzu
BACKGROUND: Pharmaceutical drug shortages (DSs) are a global problem which presents challenges to countries around the world. Shortages of pharmaceutical products may have a direct detrimental impact on public health and patients' wellbeing by causing delayed, or even lack of, treatment. Moreover, DSs may force both patients and caregivers to use unfamiliar drugs, which could lead to medication errors. The objective of our study was to analyze DSs in Israel during the years 2013-2015, assessing their etiology and exploring the steps taken for their mitigation and prevention...
2017: Israel Journal of Health Policy Research
https://www.readbyqxmd.com/read/28381720/practice-of-regulatory-science-development-of-medical-devices
#6
Shingo Niimi
 Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28353174/application-of-quality-by-design-development-to-manufacturing-of-diclofenac-sodium-topical-gel
#7
Aruna Khanolkar, Viraj Thorat, Preeti Raut, Gautam Samanta
The objective of the present study was to develop and optimize generic topical gel formulation of diclofenac sodium through quality by design approaches. The quality target product profile was set for the critical quality attributes of the gel. The key material variables like hydrophilic gelling agent carbopol and penetration enhancer kolliphor were optimized using design of experiments. A central composite design was used considering viscosity and cumulative percent diffusion of the drug after 0.5, 1, 2, 4 and 6 h as responses...
March 28, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28339376/long-term-stability-of-vancomycin-hydrochloride-in-glucose-5-polyolefin-bags-the-brand-name-versus-a-generic-product
#8
Sophie Huvelle, Marie Godet, Jean-Daniel Hecq, Patricia Gillet, Jacques Jamart, Laurence M Galanti
The objectives of this study were to determine if the preparation of vancomycin hydrochloride in advance of infusion could improve the quality of the drug, time management of drug delivery, cost savings of drug delivery, and to investigate the long-term stability of vancomycin hydrochloride (brand name Vancocin®) infusion in glucose 5% polyolefin bags versus the generic (Vancomycine®) at 5°C ± 3°C. Five bags of each infusion 1 g/100 mL vancomycin hydrochloride in 5% glucose (Vancocin ® and Vancomycine®) were stored up to 57 days at 5°C ± 3°C...
September 2016: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28292999/-outcomes-of-an-independent-clinical-study-to-compare-branded-and-generic-formulations-of-sustained-release-oxycodone
#9
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/28280742/main-reasons-for-registration-application-refusal-of-generic-and-similar-pharmaceutical-drug-products-by-the-brazilian-health-regulatory-agency-anvisa
#10
Ana Cerúlia Moraes do Carmo, Stefânia Schimaneski Piras, Nayrton Flávio Moura Rocha, Tais Gratieri
Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015...
2017: BioMed Research International
https://www.readbyqxmd.com/read/28257998/the-battle-of-nano-paclitaxel
#11
REVIEW
Alexandros Marios Sofias, Michael Dunne, Gert Storm, Christine Allen
Paclitaxel (PTX) is one of the three most widely used chemotherapeutic agents, together with doxorubicin and cisplatin, and is first or second line treatment for several types of cancers. In 2000, Taxol, the conventional formulation of PTX, became the best selling cancer drug of all time with annual sales of 1.6 billion. In 2005, the introduction of the albumin-based formulation of PTX, known as Abraxane, ended Taxol's monopoly of the PTX market. Abraxane's ability to push the Taxol innovator and generic formulations aside attracted fierce competition amongst competitors worldwide to develop their own unique, new and improved formulation of PTX...
February 28, 2017: Advanced Drug Delivery Reviews
https://www.readbyqxmd.com/read/28250671/generic-versus-branded-medicines-an-observational-study-among-patients-with-chronic-diseases-attending-a-public-hospital-outpatient-department
#12
Manisha Das, Supriyo Choudhury, Somnath Maity, Avijit Hazra, Tirthankar Pradhan, Aishee Pal, Ranendra Kumar Roy
BACKGROUND: The concept of generic prescription is widely accepted in various parts of the world. Nevertheless, it has failed to gain popularity in India due to factors such as nonavailability and distrust on the product quality. However, since 2012, the Government of West Bengal, India, has initiated exclusive generic drug outlets called "fair price medicine shop" (FPMS) inside the government hospital premises in a "public-private-partnership" model. This study was undertaken to evaluate the experience and attitude of patients who were consuming generic drugs purchased from these FPMS...
January 2017: Journal of Natural Science, Biology, and Medicine
https://www.readbyqxmd.com/read/28247180/registry-based-pragmatic-trials-in-heart-failure-current-experience-and-future-directions
#13
REVIEW
Lars H Lund, Jonas Oldgren, Stefan James
PURPOSE OF REVIEW: Randomized controlled trials (RCTs) in heart failure (HF) are becoming increasingly complex and expensive to conduct and if positive deliver expensive therapy tested only in selected populations. RECENT FINDINGS: Electronic health records and clinical cardiovascular quality registries are providing opportunities for pragmatic and registry-based prospective randomized clinical trials (RRCTs). Simplified regulatory, ethics, and consent procedures; recruitment integrated into real-world care; and simplified or automated baseline and outcome collection allow assessment of study power and feasibility, fast and efficient recruitment, delivery of generalizable findings at low cost, and potentially evidence-based and novel use of generic drugs with low costs to society...
April 2017: Current Heart Failure Reports
https://www.readbyqxmd.com/read/28240353/carbamazepine-versus-phenytoin-monotherapy-for-epilepsy-an-individual-participant-data-review
#14
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/28196335/paternal-nicotine-exposure-alters-hepatic-xenobiotic-metabolism-in-offspring
#15
Markus P Vallaster, Shweta Kukreja, Xin Y Bing, Jennifer Ngolab, Rubing Zhao-Shea, Paul D Gardner, Andrew R Tapper, Oliver J Rando
Paternal environmental conditions can influence phenotypes in future generations, but it is unclear whether offspring phenotypes represent specific responses to particular aspects of the paternal exposure history, or a generic response to paternal 'quality of life'. Here, we establish a paternal effect model based on nicotine exposure in mice, enabling pharmacological interrogation of the specificity of the offspring response. Paternal exposure to nicotine prior to reproduction induced a broad protective response to multiple xenobiotics in male offspring...
February 14, 2017: ELife
https://www.readbyqxmd.com/read/28194534/the-impact-of-physician-level-drug-budgets-on-prescribing-behavior
#16
Katharina Elisabeth Fischer, Taika Koch, Karel Kostev, Tom Stargardt
To contain pharmaceutical spending, drug budgets have been introduced across health systems. Apart from analyzing whether drug budgets fulfill their overall goal of reducing spending, changes in the cost and quality of prescribing and the enforcement mechanisms put in place need evaluation to assess the effectiveness of drug budgets at the physician level. In this study, we aim to analyze the cost and quality of prescribing conditional on the level of utilization of the drug budget and in view of varying levels of enforcement in cases of overspending...
February 13, 2017: European Journal of Health Economics: HEPAC: Health Economics in Prevention and Care
https://www.readbyqxmd.com/read/28160164/liposomal-drug-product-development-and-quality-current-us-experience-and-perspective
#17
Mamta Kapoor, Sau L Lee, Katherine M Tyner
Research in the area of liposomes has grown substantially in the past few decades. Liposomes are lipid bilayer structures that can incorporate drug substances to modify the drug's pharmacokinetic profile thereby improving drug delivery. The agency has received over 400 liposomal drug product submissions (excluding combination therapies), and there are currently eight approved liposomal drug products on the US market. In order to identify the pain points in development and manufacturing of liposomal drug products, a retrospective analysis was performed from a quality perspective on submissions for new and generic liposomal drug products...
February 3, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28132580/real-world-outcomes-in-2-646-psoriasis-patients-one-in-five-has-pasi-%C3%A2-10-and-or-dlqi-%C3%A2-10-under-ongoing-systemic-therapy
#18
J M Norlin, P S Calara, U Persson, M Schmitt-Egenolf
Background Although biologics introduced a new era in psoriasis care when available a decade ago, it is unclear to what extent the available systemic treatments treat patients adequately. Objective To analyse the clinical severity and quality of life of the psoriasis population in Sweden treated with systemics. Methods Data included 2,646 patients from the Swedish Registry for Systemic Treatment of Psoriasis. Average Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and EQ-5D were reported...
January 30, 2017: Journal of Dermatological Treatment
https://www.readbyqxmd.com/read/28130773/identification-of-substandard-medicines-via-disproportionality-analysis-of-individual-case-safety-reports
#19
Zahra Anita Trippe, Bruno Brendani, Christoph Meier, David Lewis
INTRODUCTION: The distribution and use of substandard medicines (SSMs) is a public health concern worldwide. The detection of SSMs is currently limited to expensive large-scale assay techniques such as high-performance liquid chromatography (HPLC). Since 2013, the Pharmacovigilance Department at Novartis Pharma AG has been analyzing drug-associated adverse events related to 'product quality issues' with the aim of detecting defective medicines using spontaneous reporting. The method of identifying SSMs with spontaneous reporting was pioneered by the Monitoring Medicines project in 2011...
January 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28114954/endoscopic-sinus-surgery-in-adult-patients-with-chronic-rhinosinusitis-with-nasal-polyps-polypess-study-protocol-for-a-randomised-controlled-trial
#20
Evelijn S Lourijsen, Corianne A J M de Borgie, Marleen Vleming, Wytske J Fokkens
BACKGROUND: Chronic rhinosinusitis with nasal polyps is a chronic disease frequently seen in otorhinolaryngological practice. Along with its chronic disease burden it creates high societal costs. Therapy consists of long-term use of medication and, if insufficient, endoscopic sinus surgery. No consensus exists on the right timing and extent of disease that warrants surgery. Furthermore, there is lack of clinical knowledge about the benefit of surgery over medication only. The current trial evaluates the clinical effectiveness and cost-effectiveness of endoscopic sinus surgery in addition to drug treatment versus medication exclusively in the adult patient group with nasal polyps...
January 23, 2017: Trials
keyword
keyword
114928
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"