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It was also planned that if sufficient RCTs were identified, an attempt would be made to assess funnel plot asymmetry due to small study effect, as this may be indicative of publication bias.
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Scientific principles suggest that using a single global reference product is reasonable, provided that it is proven comparable to the same product labeled in other major regions.
It is also the case that our legislators, generally being ignorant of things medical and scientific, will pass stupid laws.
However, Health Canada recognizes that when justifiable and where there is no undue risk, PK studies may be conducted in healthy volunteers.
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Biosimilars are seen as a cost-effective alternative to the high-priced branded biologics, offering cost advantages to both payers and patients.
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In approximately 70% of the hospitals surveyed, physicians were involved in making decisions about the process of therapeutic interchange.
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By engaging today in advocating and implementing the highly similar standard for mAb biosimilars and working with EU on their published draft guidelines, the FDA can rejoin EMA in leading the oversight of all biologics for a global patient need.
Results from the ATMOSPHERE trial, also presented at the American College of Cardiology and simultaneously published in the New England Journal of Medicine, demonstrated no benefit from adding aliskiren to enalapril.
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Bei Biosimilars ist die Situation anders, da es sich um Arzneistoffe handelt, die sich in der Herstellung und Wahl des Expressionssystem vom Originalprotein unterscheiden.
The foundation of the biosimilar development process is a concept called "Quality by Design": a robust, lengthy and iterative process that ensures our biosimilars are highly similar to the reference biologic medicine.
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However, it recognised that there would be minimal effect on incremental cost-effectiveness ratios (ICERs) given that the adverse reactions in the studies were rare.
Finally, filgrastim biosimilars show the lowest discount figures in 2008 and 2010 (11% and 8% respectively), but then rise to 32% in 2009.
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