Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective

Author:

Newman Bryan,Babiskin Andrew,Bielski Elizabeth,Boc Susan,Dhapare Sneha,Fang Lanyan,Feibus Katharine,Kaviratna Anubhav,Li Bing V.,Luke Markham C.,Ma Tian,Spagnola Michael,Walenga Ross L.,Wang Zhong,Zhao Liang,El-Gendy Nashwa,Bertha Craig M.,Abd El-Shafy Mohammed,Gaglani Dhaval K.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference114 articles.

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3. Addressing the regulatory and scientific challenges with generic orally inhaled drug products;Newman;Pharmaceut. Med.,2020

4. In vitro considerations to support bioequivalence of locally acting drugs in dry powder inhalers for lung diseases;Lee;The AAPS Journal,2009

5. Device selection and outcomes of aerosol therapy: evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology;Dolovich;Chest,2005

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