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https://www.readbyqxmd.com/read/29329941/analysis-of-refuse-to-file-policy-for-generic-drug-application-in-taiwan
#1
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/29322470/associations-between-the-drug-burden-index-potentially-inappropriate-medications-and-quality-of-life-in-residential-aged-care
#2
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/29300350/exploring-the-knowledge-and-perception-of-generic-medicines-among-final-year-undergraduate-medical-pharmacy-and-nursing-students-in-sierra-leone-a-comparative-cross-sectional-approach
#3
Peter Bai James, Abdulai Jawo Bah, Emmanuel Kamanda Margao, Christian Hanson, John Alimamy Kabba, Shazia Qasim Jamshed
Most low-income nations have national medicine policy that emphasized the use of generic medicines in the public health sector. However, the use of generics is often debatable as there are concerns over its efficacy, quality, and safety compared to their branded counterparts. This study was conducted to compare the knowledge and perception of generic medicines among final year undergraduate medical, pharmacy, and nursing students in Sierra Leone. We conducted a questionnaire-based cross-sectional study among these students at the College of Medicine and Allied Health Sciences University of Sierra Leone...
January 4, 2018: Pharmacy (Basel, Switzerland)
https://www.readbyqxmd.com/read/29282055/knowledge-attitudes-and-practices-of-community-pharmacists-on-generic-medicines-in-palestine-a-cross-sectional-study
#4
Naser Y Shraim, Tasneem A Al Taha, Rawan F Qawasmeh, Hiba N Jarrar, Maram A N Shtaya, Lama A Shayeb, Waleed M Sweileh
BACKGROUND: Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine...
December 28, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/29242394/a-qrm-discussion-of-microbial-contamination-of-non-sterile-drug-products-using-fda-s-and-ema-s-warning-letters-between-2008-and-2016
#5
Ana M C Santos, Mara S Doria, Luis Soares, António J Almeida, José C Menezes
Microbial quality control of non-sterile drug products is a concern to regulatory agencies and the pharmaceutical industry since the 1960's. Despite being an old challenge to companies, microbial contamination still affects a high number of manufacturers of non-sterile products. Consequences go well beyond the obvious direct costs related to batch rejections or product recalls, as human lives and a company's reputation are significantly impacted as well if such event occurs. To better manage this type of events and establish effective mitigation strategies, it is necessary to understand the microbial hazards involved in the manufacturing processes of non-sterile drug products, be able to evaluate their potential impact on final product quality and apply mitigation actions ...
December 14, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29226862/the-rationale-and-design-of-the-reducing-pathology-in-alzheimer-s-disease-through-angiotensin-targeting-radar-trial
#6
Patrick G Kehoe, Peter S Blair, Beth Howden, David L Thomas, Ian B Malone, Jeremy Horwood, Clare Clement, Lucy E Selman, Hannah Baber, Athene Lane, Elizabeth Coulthard, Anthony Peter Passmore, Nick C Fox, Ian B Wilkinson, Yoav Ben-Shlomo
BACKGROUND: Anti-hypertensives that modify the renin angiotensin system may reduce Alzheimer's disease (AD) pathology and reduce the rate of disease progression. OBJECTIVE: To conduct a phase II, two arm, double-blind, placebo-controlled, randomized trial of losartan to test the efficacy of Reducing pathology in Alzheimer's Disease through Angiotensin TaRgeting (RADAR). METHODS: Men and women aged at least 55 years with mild-to-moderate AD will be randomly allocated 100 mg encapsulated generic losartan or placebo once daily for 12 months after successful completion of a 2-week open-label phase and 2-week placebo washout to establish drug tolerability...
2018: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/29189133/risk-assessment-and-monitoring-of-antibody-responses-to-biosimilars-in-chronic-inflammatory-diseases
#7
Iris Detrez, Ann Gils
BACKGROUND: The expiry of the patent of several leading biological medicinal products has led to a surge in the development of 'biosimilar' products. In contrast to generic small-molecule medicines, biosimilars are not identical to their reference medicinal products. METHODS: Full comparability in quality as well as in preclinical and clinical issues is required to register a biosimilar. Since immunogenicity is key for biological medicinal products, regulatory authorities in the European Union require antidrug antibody (ADA) responses to be evaluated and to be approached from a safety perspective...
November 29, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/29186163/development-and-validation-of-a-tool-to-assess-knowledge-and-attitudes-towards-generic-medicines-among-students-in-greece-the-attitude-towards-generics-attogen-questionnaire
#8
Philip J Domeyer, Vassilis Aletras, Fotios Anagnostopoulos, Vasiliki Katsari, Dimitris Niakas
INTRODUCTION: The use of generic medicines is a cost-effective policy, often dictated by fiscal restraints. To our knowledge, no fully validated tool exploring the students' knowledge and attitudes towards generic medicines exists. The aim of our study was to develop and validate a questionnaire exploring the knowledge and attitudes of M.Sc. in Health Care Management students and recent alumni's towards generic drugs in Greece. MATERIALS AND METHODS: The development of the questionnaire was a result of literature review and pilot-testing of its preliminary versions to researchers and students...
2017: PloS One
https://www.readbyqxmd.com/read/29175789/quality-surveillance-of-immediate-release-aceclofenac-tablets-100-mg-available-in-local-market
#9
Rabia Bushra, Muhammad Harris Shoaib, Huma Ali, Yousra Shafiq, Farya Zafar, Shazia Alam, Nousheen Aslam
Aceclofenac is considered to be an effective drug that has been widely prescribed for multi-medical complaints globally. Owing to high demand many generic counterpart of aceclofenac tablets are now available in the commercial market. The aim of the present work is to evaluate and compare the quality attributes of various national/local brands of aceclofenac immediate release tablets (100mg) with the standard multi-national brand available in Pakistan. Physico-chemical evaluation was performed by determining the average tablet weight, thickness, hardness, disintegration time, percent dissolution and assay...
November 2017: Pakistan Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29170118/generic-drug-device-combination-products-regulatory-and-scientific-considerations
#10
Stephanie H Choi, Yan Wang, Denise S Conti, Sam G Raney, Renishkumar Delvadia, Andrew A Leboeuf, Kimberly Witzmann
Complex regulatory and scientific considerations exist for drug-device combination products submitted under an Abbreviated New Drug Application. The Agency has published several guidances to aid industry in the development of a generic drug-device combination product: providing recommendations on the types of studies necessary to establish bioequivalence, providing considerations on product quality and performance for certain types of device constituents, and most recently, providing tools to assess the proposed user interface when compared to the user interface of the Reference Listed Drug...
November 21, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29168243/iron-sucrose-assessing-the-similarity-between-the-originator-drug-and-its-intended-copies
#11
Tiziana Di Francesco, Erik Philipp, Gerrit Borchard
Iron sucrose (IS) is a complex nanocolloidal intravenous suspension used in the treatment of iron-deficiency anemia. Follow-on IS products (iron sucrose similars (ISSs)) have obtained marketing authorization by the generic pathway, implying that identical copies of IS may be manufactured. However, recent prospective and retrospective clinical studies showed discrepancies in clinical outcomes, which might be related to differences in physicochemical properties. The aim of this work is to measure and compare the physicochemical properties of IS and three ISSs available in the market using innovative analytical procedures...
November 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/29165079/comparison-of-clobetasol-propionate-generics-using-simplified-in-vitro-bioequivalence-method-for-topical-drug-products
#12
Kelen Carine Costa Soares, Weidson Carlos de Souza, Leonardo de Souza Texeira, Marcilio Sergio Soares da Cunha-Filho, Guilherme Martins Gelfuso, Tais Gratieri
The aim of this paper is to propose a simple in vitro skin penetration experiment in which the drug is extracted from the whole skin piece as a test valid for formulation screening and optimization during development process, equivalence assessment during quality control or post-approval after changes to the product. Twelve clobetasol propionate (CP) formulations (six creams and six ointments) from the local market were used as a model to challenge the proposed methodology in comparison to in vitro skin penetration following tape-stripping for drug extraction...
November 20, 2017: Current Drug Delivery
https://www.readbyqxmd.com/read/29121918/-no-generics-doctor-the-perspective-of-general-practitioners-in-two-french-regions
#13
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/29110842/patient-reported-outcome-measures-proms-in-the-management-of-lung-cancer-a-systematic-review
#14
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
#15
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
#16
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/29101617/quality-of-medication-information-in-discharge-summaries-from-hospitals-an-audit-of-electronic-patient-records
#17
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
https://www.readbyqxmd.com/read/29079338/advances-in-experimental-and-mechanistic-computational-models-to-understand-pulmonary-exposure-to-inhaled-drugs
#18
Per Bäckman, Sumit Arora, William Couet, Ben Forbes, Wilbur de Kruijf, Amrit Paudel
Prediction of local exposure following inhalation of a locally acting pulmonary drug is central to the successful development of novel inhaled medicines, as well as generic equivalents. This work provides a comprehensive review of the state of the art with respect to multiscale computer models designed to provide a mechanistic prediction of local and systemic drug exposure following inhalation. The availability and quality of underpinning in vivo and in vitro data informing the computer based models is also considered...
October 25, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29076742/impact-of-the-us-fda-biopharmaceutics-classification-system-bcs-guidance-on-global-drug-development
#19
Mehul U Mehta, Ramana S Uppoor, Dale P Conner, Paul Seo, Jayabharathi Vaidyanathan, Donna A Volpe, Ethan Stier, Dakshina Chilukuri, Angelica Dorantes, Tapash Ghosh, Haritha Mandula, Kimberly Raines, Pariban Dhanormchitphong, Janet Woodcock, Lawrence X Yu
The FDA guidance on application of the biopharmaceutics classification system (BCS) for waiver of in vivo bioequivalence (BE) studies was issued in August 2000. Since then, this guidance has created worldwide interest among biopharmaceutical scientists in regulatory agencies, academia, and industry toward its implementation and further expansion. This article describes how the review implementation of this guidance was undertaken at the FDA and results of these efforts over last dozen years or so across the new, and the generic, drug domains are provided...
November 7, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/29073983/drug-policy-in-poland
#20
Karina Jahnz-Różyk, Pawel Kawalec, Krzysztof Malinowski, Katarzyna Czok
We presented a general overview of the health care system as well as the pricing and reimbursement environment in Poland. Poland aims to ensure proper access to safe and effective medicines while reducing patients' share in treatment costs. Nevertheless, the co-payment for pharmacotherapy is still high (more than 60%). The key policymaker and regulator in the system is the Ministry of Health, which is supported by the Polish Agency for Health Technology Assessment and Tariff System (Agencja Oceny Technologii Medycznych i Taryfikacji), responsible for evaluating applicant drugs, and the Economic Commission, responsible for negotiating the official sales prices and conditions for reimbursement with pharmaceutical companies (e...
September 2017: Value in Health Regional Issues
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