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A new regulatory approach to nebuliser testing by ProQuest

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For a number of years nebulisers were tested in accordance with the European Committee for Standardisation (CEN] Standard for Respiratory Therapy Equipment EN 13544-1. In 2006 the EMEA issued guidance which recognised that the safety and efficacy of a nebulised product depends on the nebuliser/drug combination. The proposed monograph (Ph.Eur.

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