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Exploring the 505(b)(2) Route for Systemic and Regional Therapy via Pulmonary Delivery

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The Advantages of Using Respirable Engineered Spray-dried Dry Powder

Inhaled drug products offer several advantages over other dosage forms, including more targeted drug delivery, which can mean a lower dose is required, in turn reducing side-effects. Developing generic versions of complex products is increasingly challenging and it is important to consider a regulatory strategy to achieve market approval as quickly and efficiently as possible, using a simple and efficient pathway. In this article,  Aditya R. Das at Recipharm explores the use of the 505(b)(2) application route to advance inhalation drugs to market and the advantages of using respirable engineered spray-dried powder for the development of these products.

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