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Development and Approval of Inhaled Respiratory Drugs: A US Regulatory Science Perspective

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Controlled Pulmonary Drug Delivery

Part of the book series: Advances in Delivery Science and Technology ((ADST))

Abstract

This chapter focuses on the regulatory science aspects of the postdiscovery development and approval of the inhaled respiratory drug products intended for local action. It provides a brief treatise of the CMC, in vitro and in vivo evaluations for development and approval of inhalation aerosols in the US. In addition, it includes a brief discussion on scientific considerations related to potential extended-release inhalation drug products. Regulatory paradigms for approval of generic inhalation drug products are also discussed.

This article represents the personal opinions of the authors, and does not necessarily represent the views or policies of any regulatory agency or organization(s) of the author current or past affiliation.

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Authors and Affiliations

  1. Axar Pharmaceuticals, Irvine, CA, 92620, USA

    Gur Jai Pal Singh

  2. 22386 Amber Eve Drive, Corona, CA, 92883, USA

    Gur Jai Pal Singh

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  1. Gur Jai Pal Singh
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  2. Guirag Poochikian
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  1. , Pharmaceutics Division - PHR 4.214, University of Texas, University Station 1, Austin, 78712, USA

    Hugh D.C. Smyth

  2. Eshelman School of Pharmacy, Division of Molecular Pharmaceutics, University of North Carolina, Chapel Hill, 27599, North Carolina, USA

    Anthony J. Hickey

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Singh, G.J.P., Poochikian, G. (2011). Development and Approval of Inhaled Respiratory Drugs: A US Regulatory Science Perspective. In: Smyth, H., Hickey, A. (eds) Controlled Pulmonary Drug Delivery. Advances in Delivery Science and Technology. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-9745-6_21

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