Particle Size Distribution Equivalency as Novel Predictors for Bioequivalence

Author:

Ngeacharernkul Pratak,Stamatis Stephen D.,Kirsch Lee E.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Reference57 articles.

1. Crowder TM, Hickey AJ, Louey MD, Orr NA. Guide to pharmaceutical particulate science. London: Interpharm/CRC; 2003.

2. U.S. National Archives and Records Administration. Title 21: Food and drugs. Chapter1-Food and Drug Administration. Code of Federal Regulations: part 320-bioavailability and bioequivalence requirements. 2017.

3. Food and Drug Administration. Draft guidance on cyclosporine: emulsion form/ophthalmic route. 2013.

4. Azzalini A, Capitanio A. The skew-normal and related families: Cambridge University Press; 2014. URL https://www.R-project.org/

5. Bikhazi AB, Higuchi WI. Interfacial barriers to the transport of sterols and other organic compounds at the aqueous polysorbate 80-hexadecane Interface. Biochim Biophys Acta Biomembr. 1971;233(3):676–87.

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