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Change management considerations for orally inhaled and nasal drug products and other drug device combination products in the European Union

delete2026-06-12
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PRE
AI
M
Marielle Calderini
B
Beatrice Grand-Demars
L
Lee Nagao *
DOI:10.1016/j.xphs.2026.104357delete
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Abstract

Abstract

En 中文
In this paper, the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), discusses the current regulatory landscape associated with change management of orally inhaled and nasal drug products (OINDP) and other drug device combination products in the European Union.

Journal

Journal of Pharmaceutical Sciences cover
Journal of Pharmaceutical Sciences
IF:
3.8
Papers:
1.1W
Citations:
2.6W

Organization

N
nemera services
Scholars:
2
Papers: 1
Citations: 0
I
innovation & development center
Scholars:
2
Papers: 1
Citations: 0
F
faegre drinker biddle & reath llp
Scholars:
2
Papers: 1
Citations: 0
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