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Updated: May 15, 2025

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吸入式和鼻腔生物制剂:分析,配方,开发和监管方面的考虑

David Cipolla1, Christopher J Gruenloh2, Nani Kadrichu3

  • 1Research Department, Insmed Incorporated, Bridgewater, New Jersey, USA.

Journal of aerosol medicine and pulmonary drug delivery
|April 8, 2025
PubMed
概括

吸入式和鼻腔生物制剂 (INBs) 与注射剂相比具有优势,但需要仔细开发. 本报告通过讨论化学,制造和控制 (CMC) 和生物等价性 (BE) 考虑来指导INB的发展.

关键词:
生物学的生物学.吸入的 吸入的 吸入的大分子分子的大分子.鼻子 鼻子 鼻子监管部门的监管机构.呼吸道 呼吸道 呼吸道

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