Author:
Weber Benjamin,Hochhaus Guenther,Adams Wallace,Lionberger Robert,Li Bing,Tsong Yi,Lee Sau L.
Publisher
Springer Science and Business Media LLC
Reference19 articles.
1. 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;11:414–23.
2. Shi S, Hickey AJ. Multivariate data analysis as a semi-quantitative tool for interpretive evaluation of comparability or equivalence of aerodynamic particle size distribution profiles. AAPS PharmSciTech. 2009;10:1113–20.
3. European Medicines Agency. Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003504.pdf
. Accessed 13 June 2012.
4. Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for industry—bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action (draft guidance), June 1999.
http://www.fda.gov/ohrms/dockets/ac/00/backgrd/36099b1l.pdf
. Accessed 13 June 2012.
5. Cheng B, Shao J. Profile analysis for assessing in vitro bioequivalence. J Biopharm Stat. 2002;12:323–32.
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