Current Issue : October - December Volume : 2013 Issue Number : 4 Articles : 4 Articles
Generic medicines are those where patent protection has expired, and which may be produced by manufacturers\r\nother than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a\r\ncost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator\r\nequivalents. Our objective is to provide a high-level description of what generic medicines are and how they differ,\r\nat a regulatory and legislative level, from originator medicines. We describe the current and historical regulation of\r\nmedicines in the world�s two main pharmaceutical markets, in addition to the similarities, as well as the differences,\r\nbetween generics and their originator equivalents including the reasons for the cost differences seen between\r\noriginator and generic medicines. Ireland is currently poised to introduce generic substitution and reference pricing.\r\nThis article refers to this situation as an exemplar of a national system on the cusp of significant health policy\r\nchange, and specifically details Ireland�s history with usage of generic medicines and how the proposed changes\r\ncould affect healthcare provision...
High-level expression of recombinant human growth hormone (hGH) in Escherichia coli (E. coli) leads to the formation of\r\ninsoluble aggregates as inclusion bodies devoid of biological activity. Until recently, significant efforts have been made to\r\nimprove the recovery of active hGH from inclusion bodies. Here, we developed an efficient procedure for the production of\r\ncompletely soluble hGH by minimizing the formation of inclusion bodies and optimizing protein purification conditions.\r\nUnder the newly established conditions we were able to obtain most of the total hGH in the soluble fraction. We show that\r\nthe soluble protein can be efficiently purified in high yield by a series of chromatographic procedures. We analyzed the\r\nresulting hGH using various analytical techniques such as reversed-phase high-performance liquid chromatography (RPHPLC),\r\nsize-exclusion chromatography (SEC), matrix-assisted laser desorption ionization time-of-flight (MALDI-TOF) mass\r\nspectrometry, and circular dichroism (CD). These multiple analyses support the conclusion that we obtained highly pure\r\nhGH with the expected molecular mass and intact secondary structure. The biological activity of purified hGH was also\r\nconfirmed by evaluating its growth-promoting effect using a cell proliferation assay. Taken together, we describe a\r\nstraightforward strategy for the production of completely soluble and biologically active hGH in E. coli....
Background: Multiple sclerosis (MS) is a highly debilitating immune mediated disorder and the second most\r\ncommon cause of neurological disability in young and middle-aged adults. Iran is amongst high MS prevalence\r\ncountries (50/100,000). Economic burden of MS is a topic of important deliberation in economic evaluations study.\r\nTherefore determining of cost-effectiveness interferon beta (INF �Ÿ) and their copied biopharmaceuticals (CBPs) and\r\nbiosimilars products is significant issue for assessment of affordability in Lower-middle-income countries (LMICs).\r\nMethods: A literature-based Markov model was developed to assess the cost-effectiveness of three INF �Ÿs products\r\ncompared with placebo for managing a hypothetical cohort of patients diagnosed with relapsing remitting MS\r\n(RRMS) in Iran from a societal perspective. Health states were based on the Kurtzke Expanded Disability Status Scale\r\n(EDSS). Disease progression transition probabilities for symptom management and INF �Ÿ therapies were obtained\r\nfrom natural history studies and multicenter randomized controlled trials and their long term follow up for RRMS\r\nand secondary progressive MS (SPMS). A cross sectional study has been developed to evaluate cost and utility.\r\nTransitions among health states occurred in 2-years cycles for fifteen cycles and switching to other therapies was\r\nallowed. Calculations of costs and utilities were established by attachment of decision trees to the overall model.\r\nThe incremental cost effectiveness ratio (ICER) of cost/quality adjusted life year (QALY) for all available INF �Ÿ\r\nproducts (brands, biosimilars and CBPs) were considered. Both costs and utilities were discounted. Sensitivity\r\nanalyses were done to assess robustness of model.\r\nResults: ICER for Avonex, Rebif and Betaferon was 18712, 11832, 15768 US Dollars ($) respectively when utility\r\nattained from literature review has been considered. ICER for available CBPs and biosimilars in Iran was $847,\r\n$6964 and $11913.\r\n(Continued on next page)...
not available....
Loading....