Guidance on Drug Substance Particle Size Controls for Solid Oral Dose Forms-Reference-Cited by-同舟云学术

Guidance on Drug Substance Particle Size Controls for Solid Oral Dose Forms

Published:2018 Issue: Volume: Page:277-302
ISSN:2210-7371
Container-title:Particles and Nanoparticles in Pharmaceutical Products
language:
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Author:

Hilden Jon,Burcham Christopher L.,Stamatis Stephen D.,Miesle Jim,Coutant Carrie A.

Publisher

Springer International Publishing

Link

http://link.springer.com/content/pdf/10.1007/978-3-319-94174-5_7

Reference22 articles.

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3. Dokoumetzidis A, Macheras P (2006) A century of dissolution research: from Noyes and Whitney to the biopharmaceutics classification system. Int J Pharm 321:1–11. https://doi.org/10.1016/j.ijpharm.2006.07.011

4. Harbour G (2006) ICH Q9 Briefing pack II, Online Presentation [WWW Document]. URL http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Q9_Briefing_Pack/Tools_-_Applications.pdf . Accessed 29 Aug 17

5. Hilden J, Schrad M, Kuehne-Willmore J, Sloan J (2012) A first-principles model for prediction of product dose uniformity based on drug substance particle size distribution. J Pharm Sci 101:2364–2371. https://doi.org/10.1002/jps.23130

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