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Pharmaceutical economics

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https://www.readbyqxmd.com/read/28101462/identification-and-molecular-characterization-of-genes-coding-pharmaceutically-important-enzymes-from-halo-thermo-tolerant-bacillus
#1
Azam Safary, Rezvan Moniri, Maryam Hamzeh-Mivehroud, Siavoush Dastmalchi
Purpose: Robust pharmaceutical and industrial enzymes from extremophile microorganisms are main source of enzymes with tremendous stability under harsh conditions which make them potential tools for commercial and biotechnological applications. Methods: The genome of a Gram-positive halo-thermotolerant Bacillus sp. SL1, new isolate from Saline Lake, was investigated for the presence of genes coding for potentially pharmaceutical enzymes. We determined gene sequences for the enzymes laccase (CotA), l-asparaginase (ansA3, ansA1), glutamate-specific endopeptidase (blaSE), l-arabinose isomerase (araA2), endo-1,4-β mannosidase (gmuG), glutaminase (glsA), pectate lyase (pelA), cellulase (bglC1), aldehyde dehydrogenase (ycbD) and allantoinases (pucH) in the genome of Bacillus sp...
December 2016: Advanced Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28101128/simultaneous-determination-of-newly-developed-antiviral-agents-in-pharmaceutical-formulations-by-hplc-dad
#2
Nourah Zoman Al-Zoman, Hadir Mohamed Maher, Amal Al-Subaie
BACKGROUND: Ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira Pak(®)) are the newest medicines approved for use in the treatment of hepatitis C virus (HCV) and are available in tablet form as an oral combination. Specifically, these agents are indicated in the treatment of HCV in patients with genotype 1 infection. Due to the therapeutic importance and increased use of Viekira Pak, proper methods for its determination in bulk and pharmaceutical formulations must be developed. RESULTS: The present study describes the development and validation of a simple, rapid, selective and economical reverse phase high performance liquid chromatography-diode array detection (HPLC-DAD) method for the simultaneous determination of paritaprevir (PAR), ombitasvir (OMB), dasabuvir(DAS) and ritonavir (RIT) in bulk and pharmaceutical preparations...
2017: Chemistry Central Journal
https://www.readbyqxmd.com/read/28100464/six-month-market-exclusivity-extensions-to-promote-research-offer-substantial-returns-for-many-drug-makers
#3
Aaron S Kesselheim, Benjamin N Rome, Ameet Sarpatwari, Jerry Avorn
To incentivize pharmaceutical manufacturers to invest in areas of unmet medical need, policy makers frequently propose extending the market exclusivity period of desired drugs. Some such proposals are modeled after the pediatric exclusivity patent extension program, which since 1997 has provided six additional months of market exclusivity for drugs studied in children. The most recent proposal would encourage rare disease research by providing six months of extended exclusivity for any existing drug that is granted subsequent FDA approval for a new rare disease indication...
January 18, 2017: Health Affairs
https://www.readbyqxmd.com/read/28087127/the-route-from-problem-to-solution-in-multistep-continuous-flow-synthesis-of-pharmaceutical-compounds
#4
Péter Bana, Róbert Örkényi, Klára Lövei, Ágnes Lakó, György István Túrós, János Éles, Ferenc Faigl, István Greiner
Recent advances in the field of continuous flow chemistry allow the multistep preparation of complex molecules such as APIs (Active Pharmaceutical Ingredients) in a telescoped manner. Numerous examples of laboratory-scale applications are described, which are pointing towards novel manufacturing processes of pharmaceutical compounds, in accordance with recent regulatory, economical and quality guidances. The chemical and technical knowledge gained during these studies is considerable; nevertheless, connecting several individual chemical transformations and the attached analytics and purification holds hidden traps...
December 29, 2016: Bioorganic & Medicinal Chemistry
https://www.readbyqxmd.com/read/28077911/a-decade-of-data-protection-for-innovative-drugs-in-canada-issues-limitations-and-time-for-a-reassessment
#5
Megan Kendall, Declan Hamill
Drug regulators in Canada and in other nations require innovative pharmaceutical companies to submit undisclosed clinical or other data as a condition of approving the marketing of new pharmaceutical products-the origination of which involves considerable effort and investment. Data protection regulations were enacted in Canada in 2006, which-to some extent-closed a loophole in intellectual property law that had previously left innovative companies with no effective data protection for their clinical data. Although the regulations were intended to clarify and effectively implement Canada's international treaty obligations in the spirit of innovation, a review of Canada's first decade of effective data protection shows that Health Canada and Canadian courts have interpreted the scope of data protection for innovative drugs in a narrow manner that undermines and is inconsistent with the intent of the regulations...
December 1, 2016: Biotechnology Law Report
https://www.readbyqxmd.com/read/28076545/economic-evaluation-of-the-programs-rede-farm%C3%A3-cia-de-minas-do-sus-versus-farm%C3%A3-cia-popular-do-brasil
#6
Marina Morgado Garcia, Augusto Afonso Guerra, Francisco de Assis Acúrcio
We conducted an economic assessment of the Pharmaceutical Assistance - Rede Farmácia de Minas Gerais-RFMG and Farmácia Popular do Brasil-FPB to ascertain which of the two models stands out as the most efficient. To do this, a model, which consisted of a study of incurred costs in both programs, up to the dispensing of medicine to citizens, was developed. The uncertainties of the proposed model were tested using the Monte Carlo method. If the entire population initially estimated in the RFMG were attended in the FPB, there would be an additional cost of R$ 139,324,050...
January 2017: Ciência & Saúde Coletiva
https://www.readbyqxmd.com/read/28063135/cost-effectiveness-of-insulin-degludec-plus-liraglutide-ideglira-in-a-fixed-combination-for-uncontrolled-type-2-diabetes-mellitus-in-sweden
#7
Åsa Ericsson, Adam Lundqvist
BACKGROUND: Patients with uncontrolled type 2 diabetes mellitus (T2DM) are a priority group for intensified therapy without weight gain and with low risk of hypoglycaemia. OBJECTIVE: This study evaluates the cost effectiveness of insulin degludec plus liraglutide (IDegLira, Xultophy(®)) compared with six potential intensification treatment options for patients with T2DM that is uncontrolled with basal insulin. METHODS: The Swedish Institute for Health Economics (IHE) Cohort Model of Type 2 Diabetes was used with Swedish input data, a 40-year time frame and a societal perspective...
January 6, 2017: Applied Health Economics and Health Policy
https://www.readbyqxmd.com/read/28057032/ethical-imperatives-of-timely-access-to-orphan-drugs-is-possible-to-reconcile-economic-incentives-and-patients-health-needs
#8
R Rodriguez-Monguio, T Spargo, E Seoane-Vazquez
BACKGROUND: More than 6,800 rare diseases and conditions have been identified in the US, which affect 25-30 million Americans. In 1983, the US Congress enacted the Orphan Drug Act (ODA) to encourage the development and marketing of drugs to treat rare diseases and conditions. This study analyzed all orphan designations and FDA approvals since 1983 through 2015, discussed the effectiveness of incentives for the development of treatments for rare diseases, and reflected on the ethical imperatives for timely access to orphan drugs...
January 5, 2017: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/28054464/economic-improvement-of-continuous-pharmaceutical-production-via-the-optimal-control-of-a-multi-feed-bioreactor
#9
Jonathan P Raftery, Melanie R DeSessa, M Nazmul Karim
Projections on the profitability of the pharmaceutical industry predict a large amount of growth in the coming years. Stagnation over the last 20 years in product development has led to the search for new processing methods leading to improvements in profitability by the reduction of operating costs or the improvement of process productivity. This work proposes a novel multi-feed bioreactor system composed of independently controlled feeds for substrate(s) and media used as a supplement and allows for the free manipulation of the bioreactor supply rate and substrate concentrations to maximize bioreactor productivity and substrate utilization while reducing operating costs...
January 5, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/28051283/incremental-cost-effectiveness-pharmacoeconomic-assessment-of-hepatitis-c-virus-therapy-an-approach-for-less-wealthy-members-of-the-common-market
#10
Diana Mance, Davor Mance, Dinko Vitezić
AIM: To develop a new method of health-economic analysis based on a marginal approach. METHODS: We tested the research hypothesis that a detailed comparative a priori incremental cost-effectiveness analysis provides the necessary input for budget impact analysis about the proper order of introduction of new therapies, and thus maximizes the cost-effectiveness bounded by the total budget constraint. For the analysis we chose a combination therapy for the treatment of hepatitis C virus (HCV) genotype 1 (GT1) infection, which was approved by the European Medicine Agency in 2015...
December 31, 2016: Croatian Medical Journal
https://www.readbyqxmd.com/read/28049892/maintenance-of-clinical-expertise-and-clinical-research-by-the-clinical-professors-at-gifu-pharmaceutical-university
#11
Tomoya Tachi, Yoshihiro Noguchi, Hitomi Teramachi
 The clinical professors at Gifu Pharmaceutical University (GPU) provide pharmaceutical services at GPU Pharmacy, Gifu University Hospital, and Gifu Municipal Hospital to keep their clinical skills up-to-date; they also perform clinical research in collaboration with many clinical institutes. The Laboratory of Clinical Pharmacy is part of the Department of Pharmacy Practice and Science, to which the clinical professors belong, and is composed of three clinical professors (a professor, an associate professor, and an assistant professor)...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28031979/nanostructured-lipid-carriers-versatile-oral-delivery-vehicle
#12
REVIEW
Neelam Poonia, Rajeev Kharb, Viney Lather, Deepti Pandita
Oral delivery is the most accepted and economical route for drug administration and leads to substantial reduction in dosing frequency. However, this route still remains a challenge for the pharmaceutical industry due to poorly soluble and permeable drugs leading to poor oral bioavailability. Incorporating bioactives into nanostructured lipid carriers (NLCs) has helped in boosting their therapeutic functionality and prolonged release from these carrier systems thus providing improved pharmacokinetic parameters...
September 2016: Future Science OA
https://www.readbyqxmd.com/read/28025926/clinical-and-economic-burden-of-elevated-blood-eosinophils-in-patients-with-and-without-uncontrolled-asthma
#13
Julian Casciano, Jerry Krishnan, Zenobia Dotiwala, Chenghui Li, Shawn X Sun
BACKGROUND: The European Respiratory Society and American Thoracic Society (ERS/ATS) published guidelines in 2014 for the evaluation and treatment of asthma. These guidelines draw attention to management of patients with asthma that remains uncontrolled despite therapy. One phenotypic characteristic of therapy-resistant asthma is eosinophil elevation. It is important to better understand the burden of care gaps in this patient subgroup in order to support improved treatment strategies in the future...
January 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28025919/amcp-partnership-forum-enabling-the-exchange-of-clinical-and-economic-information-pre-fda-approval
#14
(no author information available yet)
: Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities...
January 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28009907/status-and-prospects-in-higher-alcohols-synthesis-from-syngas
#15
REVIEW
Ho Ting Luk, Cecilia Mondelli, Daniel Curulla Ferré, Joseph A Stewart, Javier Pérez-Ramírez
Higher alcohols are important compounds with widespread applications in the chemical, pharmaceutical and energy sectors. Currently, they are mainly produced by sugar fermentation (ethanol and isobutanol) or hydration of petroleum-derived alkenes (heavier alcohols), but their direct synthesis from syngas (CO + H2) would comprise a more environmentally-friendly, versatile and economical alternative. Research efforts in this reaction, initiated in the 1930s, have fluctuated along with the oil price and have considerably increased in the last decade due to the interest to exploit shale gas and renewable resources to obtain the gaseous feedstock...
December 23, 2016: Chemical Society Reviews
https://www.readbyqxmd.com/read/28005986/a-systematic-review-of-cost-effectiveness-studies-reporting-cost-per-daly-averted
#16
Peter J Neumann, Teja Thorat, Yue Zhong, Jordan Anderson, Megan Farquhar, Mark Salem, Eileen Sandberg, Cayla J Saret, Colby Wilkinson, Joshua T Cohen
INTRODUCTION: Calculating the cost per disability-adjusted life years (DALYs) averted associated with interventions is an increasing popular means of assessing the cost-effectiveness of strategies to improve population health. However, there has been no systematic attempt to characterize the literature and its evolution. METHODS: We conducted a systematic review of cost-effectiveness studies reporting cost-per-DALY averted from 2000 through 2015. We developed the Global Health Cost-Effectiveness Analysis (GHCEA) Registry, a repository of English-language cost-per-DALY averted studies indexed in PubMed...
2016: PloS One
https://www.readbyqxmd.com/read/28005139/-heparin-induced-thrombocytopenia-type%C3%A2-ii-hit%C3%A2-ii-a%C3%A2-medical-economic-view
#17
R Riedel, A Schmieder, A Koster, S Kim, G Baumgarten, J C Schewe
BACKGROUND: In the context of inpatient and increasingly ambulatory thrombosis prophylaxis, heparins have been recognised as standard therapy for decades. In addition to the therapeutic benefit, therapy with heparins also entails the risk of undesirable side effects, such as bleeding and thrombocytopenia. Heparin-induced thrombocytopenia (HIT II) is deemed a serious side effect. AIM: In the following work, HIT II is subjected to a medico-economic consideration (treatment, pharmaceuticals, subsequent costs due to possible complications) and, with regard to a possible HIT II prophylaxis, aspects of increasingly respected patient safety are also considered...
December 22, 2016: Medizinische Klinik, Intensivmedizin und Notfallmedizin
https://www.readbyqxmd.com/read/28003311/unlocking-the-potential-of-orphan-legumes
#18
REVIEW
Christopher Cullis, Karl J Kunert
Orphan, or underutilized, legumes are domesticated legumes with useful properties, but with less importance than major world crops due to use and supply constraints. However, they play a significant role in many developing countries, providing food security and nutrition to consumers, as well as income to resource-poor farmers. They have been largely neglected by both researchers and industry due to their limited economic importance in the global market. Orphan legumes are better adapted than the major legume crops to extreme soil and climatic conditions, with high tolerance to abiotic environmental stresses such as drought...
December 21, 2016: Journal of Experimental Botany
https://www.readbyqxmd.com/read/27992309/advanced-implantable-drug-delivery-systems-via-continuous-manufacturing
#19
Mohammed Maniruzzaman, Ali Nokhodchi
Polymeric implantable drug delivery systems have remarkable potential for systemic delivery of various therapeutic agents. Generally, drug-loaded implants do not require a vehicle for delivery and can be used to attain prolonged delivery into the systemic circulation of active pharmaceutical ingredients (APIs) with enhanced drug bioavailability. Furthermore, implants can provide drug release ranging from months to years, which improves patient compliance, especially for poorly bioavailable and rapidly metabolized compounds...
2016: Critical Reviews in Therapeutic Drug Carrier Systems
https://www.readbyqxmd.com/read/27987632/the-cost-of-costing-treatments-incorrectly-errors-in-the-application-of-drug-prices-in-economic-evaluation-due-to-failing-to-account-for-the-distribution-of-patient-weight
#20
Anthony J Hatswell, Joshua Porter, Dawn Lee, Nadine Hertel, Nicholas R Latimer
BACKGROUND: The cost of pharmaceuticals dosed by weight or body surface area (BSA) can be estimated in several ways for economic evaluations. A review of 20 recent National Institute for Health and Care Excellence appraisals showed that 17 of them took the mean weight or BSA of patients, 2 costed the individual patient data from trials, and 2 fitted a distribution to patient-level data. OBJECTIVES: To investigate the estimated drug costs using different methodologies to account for patient characteristics for pharmaceuticals with a weight- or BSA-based posology...
December 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
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