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https://www.readbyqxmd.com/read/28545614/-hera-quest-hta-evaluation-of-generic-pharmaceutical-products-to-improve-quality-economic-efficiency-patient-safety-and-transparency-in-drug-product-changes-in-hospitals
#1
Miriam Gyalrong-Steur, Anita Kellermann, Rudolf Bernard, Georg Berndt, Meike Bindemann, Elfriede Nusser-Rothermundt, Steffen Amann, Myga Brakebusch, Jörg Brüggmann, Eva Tydecks, Markus Müller, Frank Dörje, Eberhard Kochs, Rainer Riedel
In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available...
April 2017: Zeitschrift Für Evidenz, Fortbildung und Qualität Im Gesundheitswesen
https://www.readbyqxmd.com/read/28539125/do-anti-malarials-in-africa-meet-quality-standards-the-market-penetration-of-non-quality-assured-artemisinin-combination-therapy-in-eight-african-countries
#2
Paul N Newton, Kara Hanson, Catherine Goodman
BACKGROUND: Quality of artemisinin-based combination therapy (ACT) is important for ensuring malaria parasite clearance and protecting the efficacy of artemisinin-based therapies. The extent to which non quality-assured ACT (non-QAACT), or those not granted global regulatory approval, are available and used to treat malaria in endemic countries is poorly documented. This paper uses national and sub-national medicine outlet surveys conducted in eight study countries (Benin, Kinshasa and Kantanga [Democratic Republic of the Congo, DRC], Kenya, Madagascar, Nigeria, Tanzania, Uganda and Zambia) between 2009 and 2015 to describe the non-QAACT market and to document trends in availability and distribution of non-QAACT in the public and private sector...
May 25, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28531119/quality-attributes-and-in-vitro-bioequivalence-of-different-brands-of-amoxicillin-trihydrate-tablets
#3
Moawia M Al-Tabakha, Khairi M S Fahelelbom, Dana Emad Eddin Obaid, Sadik Sayed
Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigate whether locally marketed amoxicillin tablets have the required chemical and physical attributes, including in vitro bioequivalence performance. Five generic products (T1, T2, T3, T4, and T5) containing combination of amoxicillin trihydrate and potassium clavulanate as 1 g strength present in immediate release tablets were compared to the reference listed drug product Augmentin® (R) for weight variation, friability, resistance to crushing, and chemical content of amoxicillin...
May 20, 2017: Pharmaceutics
https://www.readbyqxmd.com/read/28497676/assessment-of-validity-and-reliability-of-drug-hypersensitivity-quality-of-life-questionnaire-the-dutch-experience
#4
M Moayeri, H Van Os-Medendorp, I Baiardini, H Röckmann
Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) is the first questionnaire that captures health related quality of life impact in patients with drug hypersensitivity. The aim of this study was to translate and validate the original Italian 15-item DrHy-Q for use among Dutch-speaking residents. We also compared the DrHy-Q scores obtained across countries. In a prospective cohort study, the Dutch DrHy-Q was completed by 124 patients (65.3% female, age 56.8 ± 14.0) with a confirmed drug hypersensitivity...
May 2017: European Annals of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28485714/portugal-health-system-review
#5
Jorge de Almeida Simoes, Goncalo Figueiredo Augusto, Ines Fronteira, Cristina Hernandez-Quevedo
This analysis of the Portuguese health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. Overall health indicators such as life expectancy at birth and at age 65 years have shown a notable improvement over the last decades. However, these improvements have not been followed at the same pace by other important dimensions of health: child poverty and its consequences, mental health and quality of life after 65...
March 2017: Health Systems in Transition
https://www.readbyqxmd.com/read/28462792/implementation-of-a-reimbursed-medication-review-program-corporate-and-pharmacy-level-strategies
#6
Linda D MacKeigan, Nadine Ijaz, Elizabeth A Bojarski, Lisa Dolovich
BACKGROUND: In 2006, the Ontario drug plan greatly reduced community pharmacy reimbursement for generic drugs. In exchange, a fee-for-service medication review program was introduced to help patients better understand their medication therapy and ensure that medications were taken as prescribed. A qualitative study of community pharmacy implementation strategies was undertaken to inform a mixed methods evaluation of the program. PURPOSE: To describe strategies used by community pharmacies to implement a government-funded medication review service...
March 31, 2017: Research in Social & Administrative Pharmacy: RSAP
https://www.readbyqxmd.com/read/28453627/patient-reported-physical-function-measures-in-cancer-clinical-trials
#7
Thomas M Atkinson, Angela M Stover, Daniel F Storfer, Rebecca M Saracino, Thomas A D'Agostino, Denise Pergolizzi, Konstantina Matsoukas, Yuelin Li, Ethan Basch
Patient-reported outcomes (PROs) are increasingly used to monitor treatment-related symptoms and physical function decrements in cancer clinical trials. As more patients enter survivorship, it is important to capture PRO physical function throughout trials to help restore pretreatment levels of function. We completed a systematic review of PRO physical function measures used in cancer clinical trials and evaluated their psychometric properties on the basis of guidelines from the US Food and Drug Administration...
January 1, 2017: Epidemiologic Reviews
https://www.readbyqxmd.com/read/28448593/benzodiazepines-z-drugs-and-the-risk-of-hip-fracture-a-systematic-review-and-meta-analysis
#8
Karen Donnelly, Robert Bracchi, Jonathan Hewitt, Philip A Routledge, Ben Carter
BACKGROUND: Hip fractures in the older person lead to an increased risk of mortality, poorer quality of life and increased morbidity. Benzodiazepine (BNZ) use is associated with increased hip fracture rate, consequently Z-drugs are fast becoming the physician's hypnotic prescription of choice yet data on their use is limited. We compared the risk of hip fracture associated with Z-drugs and BNZ medications, respectively, and examined if this risk varied with longer-term use. METHODS AND FINDINGS: We carried out a systematic review of the literature and meta-analysis...
2017: PloS One
https://www.readbyqxmd.com/read/28448138/the-idp-specific-force-field-ff14idpsff-improves-the-conformer-sampling-of-intrinsically-disordered-proteins
#9
Dong Song, Ray Luo, Hai-Feng Chen
Intrinsically disordered proteins (IDPs) or intrinsically disordered regions do not have a fixed tertiary structure but play key roles in signal regulation, molecule recognition, and drug targeting. However, it is difficult to study the structure and function of IDPs by traditional experimental methods because of their diverse conformations. Limitations of current generic protein force fields and solvent models were reported in the previous simulations of IDPs. We have also explored overcoming these limitations by developing the ff99IDPs and ff14IDPs force fields to correct the dihedral distribution for eight disorder-promoting residues often observed in IDPs and found encouraging improvements...
May 4, 2017: Journal of Chemical Information and Modeling
https://www.readbyqxmd.com/read/28431584/monitoring-quality-and-coverage-of-harm-reduction-services-for-people-who-use-drugs-a-consensus-study
#10
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
#11
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
#12
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
#13
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
#14
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
#15
REVIEW
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
#16
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
#17
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
#18
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
#19
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
#20
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
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