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

Autor: 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.

Publikováno v: In Advanced Drug Delivery Reviews November 2022 190

Generic substitution of epinephrine autoinjectors: Patient and caregiver perceptions and attitudes.

Autor: Ray SE; RTI International, Research Triangle Park, NC., Boudewyns V; RTI International, Research Triangle Park, NC., Oguntimein O; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Md., Conti D; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Md., Malik R; RTI International, Research Triangle Park, NC., Srivastava I; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Md., Feibus KB; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Md.

Publikováno v: The journal of allergy and clinical immunology. Global [J Allergy Clin Immunol Glob] 2023 Sep 14; Vol. 3 (1), pp. 100170. Date of Electronic Publication: 2023 Sep 14 (Print Publication: 2024).