Inhalation Sunday, October 26, 2014
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Inhalation is the only technical publication devoted exclusively to readers involved in development and production of pulmonary or nasal delivered pharmaceuticals.
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Risk management for combination products

The need for improved risk management practices for orally inhaled and nasal drug products.

Currently, no harmonized guidelines for development of combination products exists; however, developing an early understanding of the relationships between a particular formulation and a particular device can minimize the need for changes or can streamline implementation of changes in late product development and post-approval. In order to assist the industry in achieving these goals, a working group of IPAC-RS has studied the contrasting approaches to regulation and design control for these types of projects.

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