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https://www.readbyqxmd.com/read/28292999/-outcomes-of-an-independent-clinical-study-to-compare-branded-and-generic-formulations-of-sustained-release-oxycodone
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
https://www.readbyqxmd.com/read/28109310/consolidating-drug-data-on-a-global-scale-using-linked-data
#13
Milos Jovanovik, Dimitar Trajanov
BACKGROUND: Drug product data is available on the Web in a distributed fashion. The reasons lie within the regulatory domains, which exist on a national level. As a consequence, the drug data available on the Web are independently curated by national institutions from each country, leaving the data in varying languages, with a varying structure, granularity level and format, on different locations on the Web. Therefore, one of the main challenges in the realm of drug data is the consolidation and integration of large amounts of heterogeneous data into a comprehensive dataspace, for the purpose of developing data-driven applications...
January 21, 2017: Journal of Biomedical Semantics
https://www.readbyqxmd.com/read/28104414/dissolution-failure-of-solid-oral-drug-products-in-field-alert-reports
#14
Dajun Sun, Meng Hu, Mark Browning, Rick L Friedman, Wenlei Jiang, Liang Zhao, Hong Wen
From 2005 to 2014, 370 data entries of dissolution failures of solid oral drug products were assessed with respect to the solubility of drug substances, dosage forms [immediate release (IR) vs. modified release (MR)], and manufacturers (brand name vs. generic). The study results show that the solubility of drug substances does not play a significant role in dissolution failures; however, MR drug products fail dissolution tests more frequently than IR drug products. When multiple variables were analyzed simultaneously, poorly water-soluble IR drug products failed the most dissolution tests, followed by poorly soluble MR drug products and very soluble MR drug products...
January 17, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28086866/perceptions-and-utilization-of-generic-medicines-in-guatemala-a-mixed-methods-study-with-physicians-and-pharmacy-staff
#15
David Flood, Irène Mathieu, Anita Chary, Pablo García, Peter Rohloff
BACKGROUND: Access to low-cost essential generic medicines is a critical health policy goal in low-and-middle income countries (LMICs). Guatemala is an LMIC where there is both limited availability and affordability of these medications. However, attitudes of physicians and pharmacy staff regarding low-cost generics, especially generics for non-communicable diseases (NCDs), have not been fully explored in Guatemala. METHODS: Semi-structured interviews with 30 pharmacy staff and 12 physicians in several highland towns in Guatemala were conducted...
January 13, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28035215/the-role-and-choice-criteria-of-antihistamines-in-allergy-management-expert-opinion
#16
Piotr Kuna, Dariusz Jurkiewicz, Magdalena M Czarnecka-Operacz, Rafał Pawliczak, Jarosław Woroń, Marcin Moniuszko, Andrzej Emeryk
Allergic diseases are the most common chronic conditions lasting throughout the patient's life. They not only cause significant deterioration in the quality of life of patients but also lead to significant absenteeism and reduced productivity, resulting in very high costs for society. Effective and safe treatment of allergic diseases is therefore one of the main challenges for public health and should be carried out by all the specialists in family medicine, internists and paediatricians in collaboration with allergists, otorhinolaryngologists and dermatologists...
December 2016: Postȩpy Dermatologii i Alergologii
https://www.readbyqxmd.com/read/28032517/integrating-biopharmaceutics-risk-assessment-and-in-vivo-absorption-model-in-formulation-development-of-bcs-class-i-drug-using-the-qbd-approach
#17
Naseem A Charoo, Rodrigo Cristofoletti, Sun K Kim
OBJECTIVE: Clinically relevant critical quality attributes (CQA's) were identified for the development of generic drug products containing fluconazole and potential design spaces relevant to the clinical application of the drug candidate was explored. SIGNIFICANCE: A simplified scoring system for the biopharmaceutics risk assessment roadmap (BioRAM) is proposed to guide product development. METHODS: Factorial design of experiments was employed to study the effect of formulation and process variables on CQA's...
April 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28027918/building-parity-between-brand-and-generic-peptide-products-regulatory-and-scientific-considerations-for-quality-of-synthetic-peptides
#18
Larisa C Wu, Fu Chen, Sau L Lee, Andre Raw, Lawrence X Yu
Peptides are a fast growing segment in the pharmaceutical industry. Consequently, the industry and regulatory agencies are increasing their focus on the regulatory path and quality considerations for peptide development and manufacturing. Although most peptides are synthetic, manufactured by solid phase synthesis, nevertheless they are complex molecules with challenging quality and regulatory aspects. This paper provides a structured overview of relevant quality issues for chemically synthesized peptides used as active pharmaceutical ingredients (API) in drug products...
December 24, 2016: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27998293/global-pharmaceutical-regulation-the-challenge-of-integration-for-developing-states
#19
Anthony Pezzola, Cassandra M Sweet
BACKGROUND: This paper has set out to map the state of pharmaceutical regulation in the developing world through the construction of cross-national indices drawing from World Health Organization data. The last two decades have been characterized by deep changes for the pharmaceutical sector, including the complete transformation of intellectual property systems at the behest of the World Trade Organization and the consolidation of global active ingredient suppliers in China and India...
December 20, 2016: Globalization and Health
https://www.readbyqxmd.com/read/27977041/risperidone-versus-placebo-for-schizophrenia
#20
REVIEW
Ranganath D Rattehalli, Sai Zhao, Bao Guo Li, Mahesh B Jayaram, Jun Xia, Stephanie Sampson
BACKGROUND: Risperidone is the first new-generation antipsychotic drug made available in the market in its generic form. OBJECTIVES: To determine the clinical effects, safety and cost-effectiveness of risperidone compared with placebo for treating schizophrenia. SEARCH METHODS: On 19th October 2015, we searched the Cochrane Schizophrenia Group Trials Register, which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO, and registries of clinical trials...
December 15, 2016: Cochrane Database of Systematic Reviews
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