Determining equivalence of inhaled medications
نویسندگان
چکیده
منابع مشابه
Clinical equivalence testing of inhaled bronchodilators.
There are no standardized methods to demonstrate in-vivo bioequivalence of inhaled bronchodilators. The most practical method of showing therapeutic equivalence in vivo is by estimating their relative potencies (RP) in clinical efficacy studies. The RP of bronchodilators may be estimated by comparing either their bronchodilator or bronchoprotective properties. Bronchodilator studies are easier ...
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The majority of deaths in COPD are from cardiovascular causes. Several large randomized controlled trials demonstrate that inhaled anticholinergic agents ipratropium and tiotropium increase the risk of serious cardiovascular events, including cardiovascular mortality. Tiotropium Respimat is associated with a statistically significant increased risk of mortality (RR 1.52; 95% CI 1.06 to 2.16) an...
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In recent years, pathways for the development and approval of bioequivalent inhaled products have been established for regulated markets, including the European Union (EU), and a number of orally inhaled products (OIPs) have been approved in the EU solely on the basis of in vitro and pharmacokinetic data. This review describes how these development pathways are structured and their implications...
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Background – It is well known that for systemically administered drugs, such as corticosteroids, the therapeutic index cannot be improved by increasing their potency, since efficacy and safety are both attributable to circulating drug concentrations, and common receptor interactions. However, the validity of this assumption has not yet been investigated for inhaled corticosteroids, which are us...
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Two quantum finite automata are equivalent if for any input string x the two automata accept x with equal probability. In this paper, we focus on determining the equivalence for 1-way quantum finite automata with control language (CL-1QFAs) defined by Bertoni et al and measure-many 1-way quantum finite automata (MM-1QFAs) introduced by Kondacs and Watrous. It is worth pointing out that although...
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ژورنال
عنوان ژورنال: Respiratory Medicine
سال: 1995
ISSN: 0954-6111
DOI: 10.1016/0954-6111(95)90085-3