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generics drugs AND quality

Bashir Mohamed Elmahi Yousif, Siripen Supakankunti
BACKGROUND: The appropriate use of medicines is essential for the provision of quality health services, patient safety, and the rational use of health resources. In Sudan, general practitioners (GPs) provide 80 % of insured patients' health services. Pharmaceutical service costs have been increasing since 2010. OBJECTIVES: We aimed to use the World Health Organization (WHO) and International Network for the Rational Use of Drugs prescribing indicators to assess prescription quality among GPs in different types of primary healthcare centers (PHCCs) within the National Health Insurance Fund (NHIF) in Gezira State, Sudan...
September 2016: Drugs—Real World Outcomes
Jaime Galindo, Pedro Amariles, Héctor F Mueses-Marín, Jaime A Hincapié, Sebastián González-Avendaño, Ximena Galindo-Orrego
BACKGROUND: Generic drug policies are often associated with concerns about the quality and effectiveness of these products. Phase IV clinical trials may be a suitable design to assess the effectiveness and safety of generic drugs. The objective of this study was to describe the effectiveness and the safety of the generic abacavir/lamivudine and efavirenz in treatment-naïve HIV-infected patients. METHODS: A monocentric, nonrandomized, open-label, phase IV study in treatment naïve HIV-infected patients 18 years or older with indication to receive abacavir/lamivudine and efavirenz were recruited from a program that provides comprehensive outpatient consultation and continuing care...
October 3, 2016: BMC Infectious Diseases
Lisa Murray, Antonio Arias, Jibin Li, Sid Bhoopathy, Ismael J Hidalgo
To improve the quality of pharmaceutical products in their markets, several Latin American countries have begun to require that new generic products demonstrate bioequivalence against innovator or reference products. However, given the number of products involved, it is not feasible to rely on clinical studies to comply with this requirement. Instead, it makes sense to adopt or develop strategies that are appropriate to the characteristics of the region. To streamline drug development and accelerate patients' access to quality drug products, 15 years ago the United States Food and Drug Administration (FDA) decided to grant exemptions from clinical bioequivalence studies (i...
August 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Vani Nimbal, Jodi B Segal, Robert J Romanelli
BACKGROUND: Generic drug use in the outpatient setting is typically measured with adjudicated pharmacy claims; however, not all delivery systems have access to these data for their clinical populations. OBJECTIVE: To develop an algorithm to estimate generic drug use in an outpatient setting using electronic health records (EHR) data. METHODS: Twenty-five therapeutic classes were chosen with the potential for low generic use that were prescribed to managed care beneficiaries in a health care system in Northern California...
October 2016: Journal of Managed Care & Specialty Pharmacy
Assim A Alfadda, Madhawi M Al-Dhwayan, Abdulhameed A Alharbi, Basema K Al Khudhair, Omar M Al Nozha, Nawal M Al-Qahtani, Saad H Alzahrani, Wedad M Bardisi, Reem M Sallam, John J Riva, Jan L Brożek, Holger J Schünemann, Ainsley Moore
OBJECTIVE: To assist healthcare providers in evidence-based clinical decision-making for the management of overweight and obese adults in Saudi Arabia. METHODS: The Ministry of Health, Riyadh, Kingdom of Saudi Arabia assembled an expert Saudi panel to produce this clinical practice guideline in 2015. In collaboration with the methodological working group from McMaster University, Hamilton, Canada, using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, which describes both the strength of recommendation and the quality of evidence  RESULTS: After identifying 11 questions, corresponding recommendations were agreed upon as guidance for the management of overweight and obese adults...
October 2016: Saudi Medical Journal
Katja Walpurgis, Andreas Thomas, Matthias Vogel, Christian Reichel, Hans Geyer, Wilhelm Schänzer, Mario Thevis
Sotatercept (formerly ACE-011) is a glycosylated, dimeric fusion protein composed of the extracellular domain of the human activin receptor type IIA (ActRIIA) and the Fc region of human IgG1. The protein-based drug candidate acts as a ligand trap which competitively binds to activin A and other members of the transforming growth factor beta superfamily, thus blocking signalling through ActRIIA. Since the inhibition of activin A was found to significantly increase bone formation and quality, Sotatercept was originally developed for the treatment of diseases involving bone loss...
September 20, 2016: Drug Testing and Analysis
Albertino Damasceno
Hypertension is the main risk factor for morbidity and mortality in the world. In Sub-Saharan Africa, hypertension, previously almost unknown, is now a major risk factor. A paper recently published showed that mean systolic blood pressure is higher in all regions of Africa compared with other parts of the world, and, most important and contrary to what is happening in the rest of the world, it is increasing in the last years. Another important issue that characterises hypertension in Africa is its extremely low level of awareness and consequently low level of control...
September 2016: Journal of Hypertension
Christian Lanshoeft, Thierry Wolf, Markus Walles, Samuel Barteau, Franck Picard, Olivier Kretz, Sarah Cianférani, Olivier Heudi
An increasing demand of new analytical methods is associated with the growing number of biotherapeutic programs being prosecuted in the pharmaceutical industry. Whilst immunoassay has been the standard method for decades, a great interest in assays based on liquid chromatography tandem mass spectrometry (LC-MS/MS) is evolving. In this present work, the development of a generic method for the quantitative analysis of therapeutic proteins based on human immunoglobulin G (hIgG) in rat serum is reported. The method is based on four generic peptides GPSVFPLAPSSK (GPS), TTPPVLDSDGSFFLYSK (TTP), VVSVLTVLHQDWLNGK (VVS) and FNWYVDGVEVHNAK (FNW) originating from different parts of the fraction crystallizable (Fc) region of a reference hIgG1 (hIgG1A)...
November 30, 2016: Journal of Pharmaceutical and Biomedical Analysis
Simon van der Schans, Lucas M A Goossens, Melinde R S Boland, Janwillem W H Kocks, Maarten J Postma, Job F M van Boven, Maureen P M H Rutten-van Mölken
BACKGROUND: Worldwide, chronic obstructive pulmonary disease (COPD) is a highly prevalent chronic lung disease with considerable clinical and socioeconomic impact. Pharmacologic maintenance drugs (such as bronchodilators and inhaled corticosteroids) play an important role in the treatment of COPD. The cost effectiveness of these treatments has been frequently assessed, but studies to date have largely neglected the impact of treatment sequence and the exact stage of disease in which the drugs are used in real life...
September 3, 2016: PharmacoEconomics
Maíra T Teixeira, Lívia C L Sá-Barreto, Taís Gratieri, Guilherme M Gelfuso, Izabel C R Silva, Marcílio S S Cunha-Filho
Tablet subdivision is a common practice used mainly for dose adjustment. The aim of this study was to investigate how the technical aspects of production as well as the method of tablets subdivision (employing a tablet splitter or a kitchen knife) influence the accuracy of this practice. Five drugs commonly used as subdivided tablets were selected. For each drug, the innovator drug product, a scored-generic and a non-scored generic were investigated totalizing fifteen drug products. Mechanical and physical tests, including image analysis, were performed...
September 1, 2016: AAPS PharmSciTech
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
Lisa M Freeman, Cindy Rodenberg, A Narayanan, Jane Olding, Margaret A Gooding, Patricia E Koochaki
OBJECTIVES: The aims of the study were to define factors that owners consider relevant to the health-related quality of life (HRQoL) of cats, to develop an instrument based on this information, and to evaluate the validity and reliability of the final instrument (the Cat HEalth and Wellbeing [CHEW] Questionnaire). METHODS: Psychometric research techniques and guidance from the US Food and Drug Administration on outcome measures were used to develop a valid and reliable instrument...
September 2016: Journal of Feline Medicine and Surgery
Mandy Nizard, Jérémy Jost, Rakotovao Tanamasoandro, Rindra Andriambololona, Mehdi Megherbi, Gaetan Duval Solofomalala, Pierre Marquet, Pierre-Marie Preux, Voa Ratsimbazafy
PURPOSE: To determine the accessibility of treatment and the quality of antiepileptic drugs (AEDs) in the Haute Matsiatra district of Madagascar. METHODS: Cross-sectional descriptive study and interviews. Samples of 10 units of each available AED were collected, and the active ingredient was quantified by reversed-phase high-performance liquid chromatography (RP-HPLC) with photodiode-array UV detection. The quality of an AED was considered satisfactory if the quantity of active ingredient in each tablet was in the range ±15% of the average value according to the European Pharmacopeia (6th edition, 2008)...
October 2016: Seizure: the Journal of the British Epilepsy Association
Declan Walsh, Mellar Davis, Carla Ripamonti, Eduardo Bruera, Andrew Davies, Alex Molassiotis
PURPOSE: The aim of this paper is to review the existing literature related to the management of nausea and vomiting (N & V) in advanced cancer and derive clinical evidence-based recommendations for its management. METHODS: Available systematic reviews on antiemetic drug effectiveness were used. One generic systematic review of antiemetics in advanced cancer (to 2009) was updated to February 2016. Agreement on recommendations was reached between panel members, and these were voted in favor unanimously by the larger antiemetic committee membership (n = 37)...
August 17, 2016: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
Amira E Abdellah, Sirageldin M K Abdelrahman
This study was conducted to analyze the quality of prescription writing of doctors in outpatient departments of paediatric teaching hospitals in Khartoum. This study is a descriptive cross- sectional, prospective, hospital based study. Nine hundred paediatric prescriptions collected from three paediatric teaching hospitals were analyzed. Three hundred prescriptions were also collected from doctors after giving them a case scenario for which they were asked to write appropriate prescriptions. These prescriptions were also analyzed for their completeness...
2012: Sudan J Paediatr
Marília Cruz Guttier, Marysabel Pinto Telis Silveira, Vera Lucia Luiza, Andréa Dâmaso Bertoldi
This study compared the perception, knowledge, and use of generic drugs by adults in Pelotas, Rio Grande do Sul State, Brazil, using two cross-sectional population-based studies from 2002 and 2012. Study outcomes were: (a) prevalence of use of generics; (b) generics as a proportion of all medication; (c) users' perceptions of prices and quality; (d) users' knowledge of generics; and (e) strategies for acquisition of medicines. Prevalence of generics use increased from 3.6% (95%CI: 3.0-4.3) to 26.1% (95%CI: 24...
August 1, 2016: Cadernos de Saúde Pública
Wenmin Yuan, Rui Kuai, Zhipeng Dai, Yue Yuan, Nan Zheng, Wenlei Jiang, Charles Noble, Mark Hayes, Francis C Szoka, Anna Schwendeman
Doxil® is a complex parenteral doxorubicin (DOX) liposome formulation approved by the FDA. For generic doxorubicin liposomes, analyzing the release profile of DOX is important for quality control and comparability studies. However, there is no robust standard drug release assay available for doxorubicin liposomes. In this study, we describe a USP-4 apparatus assay capable of discriminating DOX liposomal formulations based on release profile. Establishment of the assay was hindered by limited DOX release from liposomes in physiological conditions at 37°C...
August 2, 2016: AAPS Journal
Ramzi Shawahna, Abdel Kareem Hroub, Eliama Abed, Sondos Jibali, Ruba Al-Saghir, Abdel Naser Zaid
Atorvastatin reduces morbidity and mortality due to cardiovascular events. This study was conducted to assess the prices and pharmaceutical quality of innovator atorvastatin 20 mg with its locally available generics in Palestine and to assess the suitability of their interchangeability. The prices of innovator and generic atorvastatin 20 mg were determined and compared. Innovator atorvastatin and four generic products were tested for their pharmaceutical quality. Tablets were tested for their drug contents, weight uniformity, hardness, disintegration and dissolution...
May 2016: Acta Poloniae Pharmaceutica
A N Zaid, M Ghanem, L Maqboul, H Zaid, A Mahasne
Bioequivalence studies are expensive, time consuming and invasive to humans. Accordingly, an alternative in vitro study (biowaivers) has been introduced for drugs which belong to BCS class I and III and for other strengths of already approved higher drug strength. The main objective of this study was to prove the biowaiver eligibility of a lower strength Ramipril/Hydrochlorothiazide (2.5/12.5 mg) tablets. Visual and pharmacopoeial quality tests were performed on the higher and lower generic and on the reference listed drug to determine whether they are pharmaceutically equivalent...
October 2016: Drug Research
Grant R Martsolf, Adam C Carle, Dennis P Scanlon
OBJECTIVE: To explore the extent to which commonly used claims-based process quality indicators can be used to create an internally valid global composite measure of physician practice quality. DATA SOURCES: Health insurance claims data (October 2007-May 2010) from 134 physician practices in Seattle, WA. STUDY DESIGN: We use confirmatory and exploratory factor analysis to develop theory- and empirically driven internally valid composite measures based on 19 quality indicators...
July 24, 2016: Health Services Research
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