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In an alternative embodiment, the hydrogenation step 2 is performed on the crude reaction mixture formed in step 1, thereby providing a one-pot reaction scheme for forming a compound according to Formula III.

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This 2-week, double-blind, multicenter trial randomized 360 patients with moderate-to severe seasonal allergic rhinitis to azelastine, 2 sprays per nostril twice daily, or cetirizine, 10-mg tablets once daily.

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Seasonal allergic rhinitis (SAR) symptoms are induced by exposure to pollens from trees, grass, weeds or seasonal mould spores, whilst perennial rhinitis (PR) is associated with environmental allergens which are generally present on a year-round basis such as house dust, animal dander and insect droppings ().

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The term “physiologically functional derivative” as used herein denotes a chemical derivative of any of the specific therapeutic agents described herein having the same or similar physiological function as the free base therapeutic agent and, for example, being convertible in the body thereto.

The effect of azelastine on the early allergic response.

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The purpose of this article is to document the discussions at the 2010 European Workshop on Equivalence Determinations for Orally Inhaled Drugs for Local Action, cohosted by the International Society for Aerosols in Medicine (ISAM) and the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS).

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