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https://www.readbyqxmd.com/read/29774560/high-resolution-separation-of-monoclonal-antibodies-mixtures-and-their-charge-variants-by-an-alternative-and-generic-cze-method
#1
Alexandre Goyon, Yannis Nicolas Francois, Olivier Colas, Alain Beck, Jean Luc Veuthey, Davy Guillarme
The determination of mAb critical quality attributes (CQA) is crucial for their successful application in health diseases. A generic CZE method was developed for the high-resolution separation of various mAb charge variants, which are often recognized as important CQA. A dynamic coating of the capillary was obtained with polyethylene oxide (PEO), whereas Bis-Tris allowed the analysis of mAbs under native conditions at pH 7.0. The effect of PEO and Bis-Tris concentrations, as well as the nature of the acidic counter ion on the method performance were systematically studied...
May 17, 2018: Electrophoresis
https://www.readbyqxmd.com/read/29769386/global-acceptance-of-biosimilars-importance-of-regulatory-consistency-education-and-trust
#2
REVIEW
Eduardo Cazap, Ira Jacobs, Ali McBride, Robert Popovian, Karol Sikora
Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics...
May 16, 2018: Oncologist
https://www.readbyqxmd.com/read/29744792/development-and-psychometrics-of-a-short-form-pharmaceutical-care-specific-measure-for-quality-of-life
#3
Phantipa Sakthong, Nontapat Sonsa-Ardjit, Pattarin Sukarnjanaset, Wipaporn Munpan, Todsaporn Sangthonganotai
Background The validated patient-reported outcomes measure of pharmaceutical therapy for quality of life (PROMPT-QoL) contains 43-items, and can be too lengthy for some applications. Objectives To develop a brief version called the PROMPT, and test its psychometric properties. Setting Four public hospitals in Bangkok, Thailand. Method Secondary analysis of three databases used to develop and evaluate the original PROMPT-QoL. Items for the short-form PROMPT were selected based on expert and patient evaluations of content and importance, and lack of redundancy...
May 9, 2018: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/29742934/drug-information-association-pharmacovigilance-and-risk-management-strategies-2017-overview-of-the-generic-drug-program-and-surveillance
#4
Howard D Chazin, John R Peters, Debra M Catterson, James L Osterhout, Linda M Forsyth, Jung E Lee, Edward K Kim, Karen B Feibus
The US Food and Drug Administration's (FDA's) generic drug program has dramatically increased the availability of affordable, high quality generic drugs. The foundation of generic drug approvals is a two-tiered regulatory framework of pharmaceutical equivalence and bioequivalence. Intrinsic to both of these is consideration of the clinical relevance of formulation and bioequivalence data to support an inference of therapeutic equivalence, based on clear evidence that there are no significant differences between the generic drug and the brand name drug...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29689305/quality-and-cost-assessment-of-a-recombinant-antibody-fragment-produced-from-mammalian-yeast-and-prokaryotic-host-cells-a-case-study-prior-to-pharmaceutical-development
#5
Kristell Lebozec, Martine Jandrot-Perrus, Gilles Avenard, Olivier Favre-Bulle, Philippe Billiald
Monoclonal antibody fragments (Fab) are a promising class of therapeutic agents. Fabs are aglycosylated proteins and so many expression platforms have been developed including prokaryotic, yeast and mammalian cells. However, these platforms are not equivalent in terms of cell line development and culture time, product quality and possibly cost of production that greatly influence the success of a drug candidate's pharmaceutical development. This study is an assessment of the humanized Fab fragment ACT017 produced from two microorganisms (Escherichia coli and Pichia pastoris) and one mammalian cell host (CHO)...
April 21, 2018: New Biotechnology
https://www.readbyqxmd.com/read/29668697/efficacy-and-safety-of-biosimilar-insulins-compared-to-their-reference-products-a-systematic-review
#6
Carolyn Tieu, Eleanor J Lucas, Mindi DePaola, Lori Rosman, G Caleb Alexander
IMPORTANCE: For nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug Administration in 2015, and subsequently Admelog and Lusduna in 2017. OBJECTIVE: To summarize the scientific evidence comparing the safety, efficacy, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products. DATA SOURCES: We conducted a systematic review using PubMed, Cochrane, Embase, Latin America and Caribbean Health Sciences, South Asian Database of Controlled Clinical Trials, and IndiaMED from their inception through January 14, 2018...
2018: PloS One
https://www.readbyqxmd.com/read/29623710/-development-of-dissolution-method-for-warfarin-sodium-tablets
#7
Ivana Lukášová, Jan Muselík, Aleš Franc
Warfarin is intensively discussed drug with narrow therapeutic index. In the past, its generic substitution was identified as a cause of bleeding. Altered quality of the active substance or varying drug content was discussed. The substance quality can be evaluated with adequate dissolution method. An official dissolution method with aqueous medium exists, however this method is non-discriminatory. In the first 15 minutes the whole amount of the active pharmaceutical ingredient is released from a tested dosage form, which does not allow comparison between tablets from different producers and it also makes difficult to track the changes throughout stability testing...
2018: Ceská a Slovenská Farmacie
https://www.readbyqxmd.com/read/29599984/a-bibliometric-analysis-of-the-global-research-on-biosimilars
#8
Akram Hernández-Vásquez, Christoper A Alarcon-Ruiz, Guido Bendezu-Quispe, Daniel Comandé, Diego Rosselli
Background: Biosimilars could be a promising option to help decrease healthcare costs and expand access to treatment. There is no previous evidence of a global bibliometric analysis on biosimilars. Therefore, we aimed to assess the quantity and quality of worldwide biosimilars research. Methods: We performed a bibliometric analysis using documents about biosimilars published until December 2016 in journals indexed in Scopus. We extracted the annual research, languages, countries, journals, authors, institutions, citation frequency, and the metrics of journals...
2018: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/29568713/translating-new-science-into-the-drug-review-process-the-us-fda-s-division-of-applied-regulatory-science
#9
Rodney Rouse, Naomi Kruhlak, James Weaver, Keith Burkhart, Vikram Patel, David G Strauss
In 2011, the US Food and drug Administration (FDA) developed a strategic plan for regulatory science that focuses on developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. In line with this, the Division of Applied Regulatory Science was created to move new science into the Center for Drug Evaluation and Research (CDER) review process and close the gap between scientific innovation and drug review. The Division, located in the Office of Clinical Pharmacology, is unique in that it performs mission-critical applied research and review across the translational research spectrum including in vitro and in vivo laboratory research, in silico computational modeling and informatics, and integrated clinical research covering clinical pharmacology, experimental medicine, and postmarket analyses...
March 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29567088/community-pharmacists-understanding-and-perceptions-of-fda-therapeutic-equivalence-standards
#10
Brandon J Euen, Hala M Fadda
BACKGROUND: Pharmacists need to demonstrate knowledge of and have confidence in Food and Drug Administration (FDA) therapeutic equivalence (TE) standards to improve acceptance of generic medicines amongst patients and other healthcare professionals. OBJECTIVE: To evaluate community pharmacists' understanding, interpretation and perceptions of the FDA TE standards to identify if further education is needed on this topic. METHODS: An anonymous, 13-item survey was piloted and then distributed by e-mail to a random sample of 287 Indiana community pharmacists...
March 7, 2018: Research in Social & Administrative Pharmacy: RSAP
https://www.readbyqxmd.com/read/29557685/magnesium-sulfate-and-calcium-channel-blocking-drugs-as-antidotes-for-acute-organophosphorus-insecticide-poisoning-a-systematic-review-and-meta-analysis
#11
Miran Brvar, Ming Yin Chan, Andrew H Dawson, Richard R Ribchester, Michael Eddleston
INTRODUCTION: Treatment of acute organophosphorus or carbamate insecticide self-poisoning is often ineffective, with tens of thousands of deaths occurring every year. Researchers have recommended the addition of magnesium sulfate or calcium channel blocking drugs to standard care to reduce acetylcholine release at cholinergic synapses. OBJECTIVE: We aimed to review systematically the evidence from preclinical studies in animals exposed to organophosphorus or carbamate insecticides concerning the efficacy of magnesium sulfate and calcium channel blocking drugs as therapy compared with placebo in reducing mortality or clinical features of poisoning...
March 20, 2018: Clinical Toxicology
https://www.readbyqxmd.com/read/29548936/evaluation-of-prescription-errors-and-prescribing-indicators-in-the-private-practices-in-bahawalpur-pakistan
#12
Muhammad Atif, Muhammad Azeem, Muhammad Rehan Sarwar, Iram Malik, Wajiha Ahmad, Fariha Hassan, Ayesha Rehman, Mahjabeen Rana
BACKGROUND: Appropriate use of medicines is important to provide quality health. The aim of this study was to assess the prescribing practices and prescription errors in the private clinic practices of Bahawalpur, Pakistan. METHODS: A cross-sectional observational study was performed in March 2015 to assess the prescribing practices and prescription errors in the private clinical practices of Bahawalpur, Pakistan. We used the standard World Health Organization (WHO) methodology to achieve the study objectives...
March 13, 2018: Journal of the Chinese Medical Association: JCMA
https://www.readbyqxmd.com/read/29547426/improving-anesthesia-safety-in-low-resource-settings
#13
Fauzia A Khan, Alan F Merry
The safety of anesthesia characteristic of high-income countries today is not matched in low-resource settings with poor infrastructure, shortages of anesthesia providers, essential drugs, equipment, and supplies. Health care is delivered through complex systems. Achieving sustainable widespread improvement globally will require an understanding of how to influence such systems. Health outcomes depend not only on a country's income, but also on how resources are allocated, and both vary substantially, between and within countries...
April 2018: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/29500761/application-of-ultra-centrifugation-and-bench-top-19-f-nmr-for-measuring-drug-phase-partitioning-for-the-ophthalmic-oil-in-water-emulsion-products
#14
Xinyi Wang, Sharadrao M Patil, David A Keire, Xiaoming Xu, Kang Chen
Generic drug products are expected to have the same active pharmaceutical ingredient (API) (Q1) with the same content (Q2) and microstructure arrangement (Q3) as the innovator product. In complex oil-in-water emulsion drugs, the hydrophobic API is mainly formulated in oil droplets stabilized by surfactant and micelles composed of extra surfactant molecules. The API phase partition in oil and water (mainly micelle) is a critical quality attribute (CQA) of emulsion product in demonstrating physicochemical equivalence using difluprednate (DFPN) emulsion product Durezol® as a model, we developed a novel low-field benchtop NMR method to demonstrate its applicability in measuring DFPN phase partition for ophthalmic oil-in-water emulsion products...
May 2018: AAPS PharmSciTech
https://www.readbyqxmd.com/read/29452176/calcium-channel-blocker-use-reduces-incident-dementia-risk-in-elderly-hypertensive-patients-a-meta-analysis-of-prospective-studies
#15
Salman Hussain, Ambrish Singh, Syed Obaidur Rahman, Anwar Habib, Abul Kalam Najmi
Calcium channel blockers (CCBs) are an established class of drug for the management of hypertension. Observational studies have found that CCB use is associated with a reduction in the risk of developing dementia; however, studies have variably linked the CCBs use with the risk of dementia. This meta-analysis aims to assess whether, in elderly hypertensive patients, the use of CCBs alters the risk of developing dementia. We searched PubMed, Embase and Cochrane from August 2013 to 21st August 2017. Studies were screened on the basis of title and abstract...
April 3, 2018: Neuroscience Letters
https://www.readbyqxmd.com/read/29439078/new-mechanism-to-identify-cost-savings-in-english-nhs-prescribing-minimising-price-per-unit-a-cross-sectional-study
#16
Richard Croker, Alex J Walker, Seb Bacon, Helen J Curtis, Lisa French, Ben Goldacre
BACKGROUND: Minimising prescription costs while maintaining quality is a core element of delivering high-value healthcare. There are various strategies to achieve savings, but almost no research to date on determining the most effective approach. We describe a new method of identifying potential savings due to large national variations in drug cost, including variation in generic drug cost, and compare these with potential savings from an established method (generic prescribing). METHODS: We used English National Health Service (NHS) Digital prescribing data, from October 2015 to September 2016...
February 8, 2018: BMJ Open
https://www.readbyqxmd.com/read/29425332/association-between-use-of-phthalate-containing-medication-and-semen-quality-among-men-in-couples-referred-for-assisted-reproduction
#17
A Broe, A Pottegård, J Hallas, T P Ahern, J Fedder, P Damkier
STUDY QUESTION: Does phthalate exposure from prescription drugs affect semen quality? SUMMARY ANSWER: Exposure to phthalate-containing drugs is associated with poor semen quality. WHAT IS KNOWN ALREADY: Phthalates and their metabolites have been shown to disrupt the hormone signalling in animal studies. One study has shown associations between medicinal phthalate exposure and poor semen quality, suggesting similar effects in humans. STUDY DESIGN, SIZE, DURATION: We included 18 515 males with poor semen quality (cases) and 31 063 males with normal semen quality (controls) registered in the Danish IVF Registry from 2006 to 2016...
February 7, 2018: Human Reproduction
https://www.readbyqxmd.com/read/29414124/a-novel-unit-dose-approach-for-the-pharmaceutical-compounding-of-an-orodispersible-film
#18
Wen Chin Foo, Yuet Mei Khong, Rajeev Gokhale, Sui Yung Chan
Orodispersible films (ODF) have clinical potential as extemporaneous pharmacy preparations for individualized pharmacotherapy. However, the conventional method of ODF preparation using a film applicator may limit its application, due to content uniformity challenges arising from viscosity changes of the casting solution and varied operator manipulation. This study proposes the unit-dose (UD) plate as an alternative to the film applicator for compounding individual ODFs. Using a design-of-experiments approach, we developed an extemporaneous ODF formulation for an antiemetic drug, ondansetron hydrochloride dihydrate (OND), at a clinically relevant dose...
March 25, 2018: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29406837/optimization-of-medication-use-at-accountable-care-organizations
#19
Chrisanne Wilks, Erik Krisle, Kimberly Westrich, Kristina Lunner, David Muhlestein, Robert Dubois
BACKGROUND: Optimized medication use involves the effective use of medications for better outcomes, improved patient experience, and lower costs. Few studies systematically gather data on the actions accountable care organizations (ACOs) have taken to optimize medication use. OBJECTIVES: To (a) assess how ACOs optimize medication use; (b) establish an association between efforts to optimize medication use and achievement on financial and quality metrics; (c) identify organizational factors that correlate with optimized medication use; and (d) identify barriers to optimized medication use...
May 30, 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29384848/economic-evaluation-of-weekends-off-antiretroviral-therapy-for-young-people-in-11-countries
#20
RANDOMIZED CONTROLLED TRIAL
Luis Enrique Tierrablanca, Jessica Ochalek, Deborah Ford, Ab Babiker, Diana Gibb, Karina Butler, Anna Turkova, Susan Griffin, Paul Revill
OBJECTIVES: To analyze the cost effectiveness of short-cycle therapy (SCT), where patients take antiretroviral (ARV) drugs 5 consecutive days a week and have 2 days off, as an alternative to continuous ARV therapy for young people infected with human immunodeficiency virus (HIV) and taking efavirenz-based first-line ARV drugs. METHODS: We conduct a hierarchical cost-effectiveness analysis based on data on clinical outcomes and resource use from the BREATHER trial...
February 2018: Medicine (Baltimore)
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