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Reference30 articles.
1. 21 CFR 320.1(e).
2. Lee SL, Adams WP, Li BV, Conner DP, Chowdhury BA, Yu LX. In vitro considerations to support bioequivalence of locally acting drugs in dry powder inhalers for lung diseases. AAPS J. 2009;11(3):414–23.
3. Lu Y, Chow SC, Zhu S. In vivo and in vitro bioequivalence testing. J Bioequivalence Bioavailab. 2014;6(2):67–74.
4. Gottlieb S. Reducing the hurdles for complex generic drug development [Internet]. 2017 [cited 2020 Jan 7]. Available from: https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/reducing-hurdles-complex-generic-drug-development. Accessed 7 Jan 2020.
5. Liu Q, Absar M, Saluja B, Guo C, Chowdhury B, Lionberger R, et al. Scientific considerations for the review and approval of first generic mometasone furoate nasal suspension spray in the United States from the bioequivalence perspective. AAPS J. 2019;21(2):1–6.