Wednesday, November 6, 2019

Powder Compaction in relation to variation of excipient and application of QbD to link Formulation to development The WritePass Journal

Powder Compaction in relation to variation of excipient and application of QbD to link Formulation to development Introduction Powder Compaction in relation to variation of excipient and application of QbD to link Formulation to development , pharmatutor.org/articles/overview-of-co-processed-pharmaceutical-excipients-formulation-aspects?page=0,0 David Schoneker, (2011), The impact of excipient variability of QbD, IPEC. Viewed Apr 20th 2012, ich.org/fileadmin/Public_Web_Site/Training/GCG_-_Endorsed_Training_Events/APEC_LSIF_JCCT_workshop_Beijing__China_Dec_08/Day_3/Impact_of_Excipient.pdf John F. Gamble, Wing-Sin Chiu, Vivienne Gray et.al, (2010), Investigation into the degree of variability in the Solid-State properties of common pharmaceutical excipients-Anhydrous Lactose, AAPS PharmSciTech, Vol. 11, No. 4. Joseph Kushner, Beth A. Langdon , John I. Hiller , Glenn T. Carlsen, (2011), Exmining the Impact of excipient material property variation on drug product quality Attributes: A Quality –by Design Study for a Roller compacted , Immediate release tablet,   Journal of Phamaceutical Sciences, Vol 100, No 6. Sai P. Chamarthy,Rodolfo Pinal,  and M. Teresa Carvajal, (2009), Elucidating raw material variability –Importance of surface properties and functionality in pharmaceutical powders, AAPS PharmSciTech, 10(3): 780–788. USP, (2011), IPC-USP 10th Science and Standards symposium: Global Quality standards for   Biologicals and Chemical Drugs, viewed Apr 20th 2012, usp.org/sites/default/files/usp_pdf/EN/meetings/04TrackI-ChemicalsConcurrentSessions.pdf

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