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https://www.readbyqxmd.com/read/28371718/comparability-study-of-rituximab-originator-and-follow-on-biopharmaceutical
#1
Othman Montacir, Houda Montacir, Murat Eravci, Andreas Springer, Stephan Hinderlich, Amirhossein Saadati, Maria Kristina Parr
Immunglobolin G (IgG)-based biopharmaceuticals are emerging on the pharmaceuticals market due to their high target selectivity in different diseases. In parallel, a growing interest by other companies to produce similar or highly similar follow-on biologics exits, once the patent of blockbuster biotherapeutics is about to expire. In correlation to their complex structure, an analytical challenge is facing the approval of these biosimilars. Health authorities (e.g. FDA and EMA) have issued several guidelines to define critical quality attributes during manufacturing process changes...
June 5, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28348532/ethical-implications-of-the-mild-encephalitis-hypothesis-of-schizophrenia
#2
Rita Riedmüller, Sabine Müller
Schizophrenia is a serious mental disease with a high mortality rate and severe social consequences. Due to insufficient knowledge about its etiopathogenesis, curative treatments are not available. One of the most promising new research concepts is the mild encephalitis hypothesis of schizophrenia, developed mainly by Karl Bechter and Norbert Müller. According to this hypothesis, a significant subgroup of schizophrenia patients suffer from a mild, but chronic, form of encephalitis with markedly different etiologies ranging from viral infections, traumas to autoimmune diseases...
2017: Frontiers in Psychiatry
https://www.readbyqxmd.com/read/28264706/erratum-to-disposal-practices-of-unused-and-expired-pharmaceuticals-among-general-public-in-kabul
#3
Mohammad Bashaar, Vijay Thawani, Mohamed Azmi Hassali, Fahad Saleem
No abstract text is available yet for this article.
March 6, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28231332/the-moderating-role-of-absorptive-capacity-and-the-differential-effects-of-acquisitions-and-alliances-on-big-pharma-firms-innovation-performance
#4
K D S Fernald, H P G Pennings, J F van den Bosch, H R Commandeur, E Claassen
In the context of increased pharmaceutical innovation deficits and Big Pharma blockbusters' patent expirations, this paper examines the moderating role of firms' absorptive capacity in external innovation activities of Big Pharma firms. The study indicates a rising interest of Big Pharma in acquisitions of and alliances with biotechnology companies. Unfortunately, this increased interest is not reflected in the number of new drugs generated by Big Pharma. We find that acquisitions of biotech companies have negatively affected Big Pharma firms' innovation performance on average but these acquisitions might have a positive effect at higher levels of acquiring firms' absorptive capacity...
2017: PloS One
https://www.readbyqxmd.com/read/28213391/the-politics-and-policies-of-regulating-generics-in-latin-america-a-survey-of-seventeen-states
#5
Cassandra M Sweet
When patents expire, are equivalent generic alternatives available to citizens? This article contributes to current discussion on access to medicine in the aftermath of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The focus is on off-patent or "generic" medicines: their product definitions, quality standards and prescription procedures. Drawing from a survey conducted of seventeen countries across the Latin American region, this article examines the differences in definition of off-patent products and the paradox of their relatively lower consumption across multiple developing states...
February 17, 2017: Journal of Health Politics, Policy and Law
https://www.readbyqxmd.com/read/28142147/history-of-erythropoiesis-stimulating-agents-the-development-of-biosimilars-and-the-future-of-anemia-treatment-in-nephrology
#6
Kamyar Kalantar-Zadeh
BACKGROUND: Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered biologic proteins derived from human, animal, or microorganism sources are a major area of growth in modern medical care, accounting for one-third of new drug approvals in the past decade. Despite benefit to patients, the use of biologics comes at a significant cost, representing one of the fastest growing segments of strained healthcare budgets around the world...
2017: American Journal of Nephrology
https://www.readbyqxmd.com/read/28116676/scientific-and-regulatory-considerations-for-generic-complex-drug-products-containing-nanomaterials
#7
Nan Zheng, Dajun D Sun, Peng Zou, Wenlei Jiang
In the past few decades, the development of medicine at the nanoscale has been applied to oral and parenteral dosage forms in a wide range of therapeutic areas to enhance drug delivery and reduce toxicity. An obvious response to these benefits is reflected in higher market shares of complex drug products containing nanomaterials than that of conventional formulations containing the same active ingredient. The surging market interest has encouraged the pharmaceutical industry to develop cost-effective generic versions of complex drug products based on nanotechnology when the associated patent and exclusivity on the reference products have expired...
January 23, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28112087/tackling-the-climate-targets-set-by-the-paris-agreement-cop-21-green-leadership-empowers-public-hospitals-to-overcome-obstacles-and-challenges-in-a-resource-constrained-environment
#8
E Weimann, B Patel
The healthcare sector itself contributes to climate change, the creation of hazardous waste, use of toxic metals such as mercury, and water and air pollution. To mitigate the effect of healthcare provision on the deteriorating environment and avoid creating further challenges for already burdened health systems, Global Green Hospitals was formed as a global network. Groote Schuur Hospital (GSH), as the leading academic hospital in Africa, joined the network in 2014. Since then, several projects have been initiated to reduce the amount of general waste, energy consumption and food waste, and create an environmentally friendlier and more sustainable hospital in a resource-constrained public healthcare setting...
December 21, 2016: South African Medical Journal, Suid-Afrikaanse Tydskrif Vir Geneeskunde
https://www.readbyqxmd.com/read/28068518/impact-of-space-environment-on-stability-of-medicines-challenges-and-prospects
#9
REVIEW
Priti Mehta, Dhara Bhayani
To upkeep health of astronauts in a unique, isolated, and extreme environment of space is the primary goal for a successful space mission, hence, safe and efficacious medications are essential for the wellness of astronauts. Space medication has been challenged with problems related to efficacy. Along with altered physiology, one of the possible reasons could be instability of space medications in the presence of harsh spaceflight environmental conditions. Altered physical and chemical stability can result in reduced potency which can result in reduced efficacy...
March 20, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28066115/comparison-of-the-knowledge-attitude-and-practices-of-doctors-nurses-and-pharmacists-regarding-the-use-of-expired-and-disposal-of-unused-medicines-in-delhi
#10
Kriti Bhayana, Harmeet Singh Rehan, Tarun Arora
OBJECTIVES: The use of out-of-date medicines and improper disposal of pharmaceutical products harm consumers and environment. To limit pharmaceutical load on the environment, it is important that healthcare professionals (HCPs) are aware of and have good practices toward their disposal. MATERIALS AND METHODS: A pretested instructor administered questionnaire containing 21 questions was used to assess knowledge, attitude, and practices (KAP) of 300 HCPs toward use and disposal of unwanted/expired medicines...
November 2016: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28061902/disposal-practices-of-unused-and-expired-pharmaceuticals-among-general-public-in-kabul
#11
Mohammadk Bashaar, Vijay Thawani, Mohamed Azmi Hassali, Fahad Saleem
BACKGROUND: Most of the medicine users remain unaware about the disposal of unused or expired medicines. The aim of this study was to know the disposal practices of unused and expired medicines among the general public in Kabul. METHODS: This was a descriptive, cross-sectional survey, conducted through face-to-face interviews using prevalidated structured questionnaire. Returned questionnaires were double-checked for accuracy. Statistical Package for Social Science (SPSS) version 23 was used for statistical analysis...
January 7, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28012020/product-safety-spillovers-and-market-viability-for-biologic-drugs
#12
John Romley, Tiffany Shih
When a pharmaceutical manufacturer experiences a safety problem, negative impacts on profitability can spread to its competitors. Reduced consumer confidence, product recalls, and litigation are limited to the responsible manufacturer only if that manufacturer can be clearly linked to the safety problem. We analyze the impact of "accountability" for safety problems on manufacturer entry decisions and investments to mitigate risk. Consistent with prior research, we find investment levels increase with accountability in a duopoly market, and that accountability can thus enhance market viability and improve consumer welfare...
December 23, 2016: International Journal of Health Economics and Management
https://www.readbyqxmd.com/read/27881996/quality-of-drug-stores-storage-practices-regulatory-compliance-in-karachi-pakistan
#13
Syed Shaukat Ali Muttaqi Shah, Baqar Shyum Naqvi, Mashhad Fatima, Asif Khaliq, Abdul Latif Sheikh, Muhammad Baqar
OBJECTIVE: To assess and evaluate the drug storage quality and regulatory compliance among privately operated drug stores of Karachi Pakistan. METHODS: A cross-sectional survey of drug stores located in Karachi was conducted from May to December 2013. A total of 1003 drug stores that were involved in the sales, purchase and dispensing of pharmaceutical products were approached by non-probability purposive sampling technique, and the information was collected using a close ended, structured questionnaire...
September 2016: Pakistan Journal of Medical Sciences Quarterly
https://www.readbyqxmd.com/read/27804787/pharmaceutical-patent-applications-in-freeze-drying
#14
REVIEW
Edmond Ekenlebie, Tomaž Einfalt, Arianna Irò Karytinos, Andrew Ingham
Injectable products are often the formulation of choice for new therapeutics; however, formulation in liquids often enhances degradation through hydrolysis. Thus, freeze-drying (lyophilization) is regularly used in pharmaceutical manufacture to reduce water activity. Here we examine its contribution to 'state of the art' and look at its future potential uses. A comprehensive search of patent databases was conducted to characterize the international patent landscape and trends in the use of freeze-drying. A total of 914 disclosures related to freeze-drying, lyophilization or drying of solid systems in pressures and temperatures equivalent to those of freeze-drying were considered over the period of 1992-2014...
September 2016: Pharmaceutical Patent Analyst
https://www.readbyqxmd.com/read/27766144/household-medical-waste-disposal-policy-in-israel
#15
Zohar Barnett-Itzhaki, Tamar Berman, Itamar Grotto, Eyal Schwartzberg
BACKGROUND: Large amounts of expired and unused medications accumulate in households. This potentially exposes the public to hazards due to uncontrolled use of medications. Most of the expired or unused medications that accumulate in households (household medical waste) is thrown to the garbage or flushed down to the sewage, potentially contaminating waste-water, water resources and even drinking water. There is evidence that pharmaceutical active ingredients reach the environment, including food, however the risk to public health from low level exposure to pharmaceuticals in the environment is currently unknown...
2016: Israel Journal of Health Policy Research
https://www.readbyqxmd.com/read/27723912/-biosimilars-in-oncology-a-therapeutic-alternative-to-the-reference-products
#16
W D Ludwig, S Dicheva
Biosimilar medicinal products (biosimilars) have been available in Europe for 10 years, allowing a wide use particularly in oncology. Biosimilars are being developed and approved by means of scientifically sound principles to assure close similarity with the reference products with regard to quality, efficacy, and safety. The scientific principles for establishing biosimilarity are the same as those for demonstrating comparability after a change in the manufacturing process of an already licensed biological...
November 2016: Zeitschrift Für Gastroenterologie
https://www.readbyqxmd.com/read/27706432/-a-fine-line-between-legal-and-illegal-oral-drug-repackaging
#17
Heberto Arboleya Casanova, Héctor Marino Zavala Sánchez, Angélica María Hernández Fernández, Dulce Janeth González Herrera
In 2009, with the implementation of the National Hospital Pharmacy Model, Mexico began regulating single-dose drugs. The repackaging of oral drugs is fundamental and critical and should be standardized by Mexican health legislation to enable quality drugs to be dispensed. Data is required on stability, compatibility, drug interactions, containers, and repackaging methods, in order to establish a new expiration date. The literature on health regulations applicable to repackaging was analyzed, revealing major conceptual imprecisions since there is no legislation in Mexico that regulates repackaging; rather, everything is carried out according to pharmacists' recommendations and criteria...
June 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
https://www.readbyqxmd.com/read/27605638/has-the-era-of-slow-growth-for-prescription-drug-spending-ended
#18
Murray Aitken, Ernst R Berndt, David Cutler, Michael Kleinrock, Luca Maini
In the period 2005-13 the US prescription drug market grew at an average annual pace of only 1.8 percent in real terms on an invoice price basis (that is, in constant dollars and before manufacturers' rebates and discounts). But the growth rate increased dramatically in 2014, when the market expanded by 11.5 percent-which raised questions about future trends. We determined the impact of manufacturers' rebates and discounts on prices and identified the underlying factors likely to influence prescription spending over the next decade...
September 1, 2016: Health Affairs
https://www.readbyqxmd.com/read/27482399/analysis-of-minimum-target-prices-for-production-of-entecavir-to-treat-hepatitis-b-in-high-and-low-income-countries
#19
Andrew Hill, Dzintars Gotham, Graham Cooke, Sanjay Bhagani, Isabelle Andrieux-Meyer, Jennifer Cohn, Joseph Fortunak
BACKGROUND: In 2013, an estimated 686,000 people died from hepatitis B virus (HBV) infection worldwide. Mass treatment programmes for hepatitis B will require very low drug costs. International treatment guidelines recommend first-line monotherapy with either entecavir or tenofovir disoproxil fumarate (TDF). While the basic patent on TDF expires in 2017/8, entecavir is already generic in several countries, including the US. The chemical structure of entecavir is related to abacavir, which costs <$200 per person-year in low-income countries...
2015: Journal of Virus Eradication
https://www.readbyqxmd.com/read/27382475/contribution-of-arab-countries-to-pharmaceutical-wastewater-literature-a-bibliometric-and-comparative-analysis-of-research-output
#20
Sa'ed H Zyoud, Shaher H Zyoud, Samah W Al-Jabi, Waleed M Sweileh, Rahmat Awang
BACKGROUND: Recently, the pharmaceutical manufacturing industry has been growing rapidly in many countries in the world, including in Arab countries. Pharmaceuticals reach aquatic environments and are prevalent at small concentrations in wastewater from the drug manufacturing industry and hospitals. Such presence also occurs in domestic wastewater and results from the disposal of unused and expired medicines. Therefore, the objective of this study was to analyze and compare the quantity and quality of publications made by researchers in Arab countries on pharmaceutical wastewater...
2016: Annals of Occupational and Environmental Medicine
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