Application of Mechanistic Models for Process Design and Development of Biologic Drug Products-Reference-Cited by-同舟云学术

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Application of Mechanistic Models for Process Design and Development of Biologic Drug Products

Published:2016-07-06 Issue:3 Volume:11 Page:200-213
ISSN:1872-5120
Container-title:Journal of Pharmaceutical Innovation
language:en
Short-container-title:J Pharm Innov

Author:

Chen Wei,Chen Xiaodong,Gandhi Rajesh,Mantri Rao V.,Sadineni Vikram,Saluja Atul

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1007/s12247-016-9250-0.pdf

Reference85 articles.

1. Group IEW. ICH harmonized tripartite guideline Q8(R2) - pharmaceutical development. International conference on harmonisation 2009.

2. Group IEW. ICH Q9, quality risk management. International conference on harmonisation 2005.

3. Group IEW. ICH Q10 Quality systems. International conference on harmonisation 2008.

4. Group CBW. A-Mab: a case study in bioprocess development. Emeryville: CASSS; 2009.

5. David Fissore RP, Antonello A. Barresi. Using mathematical modeling and prior knowledge for QbD in freeze-drying processes. Qual Des Biopharm Drug Prod Dev. 2015;18:565–93.

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1. Scale-Up Studies in Pharmaceutical Products Development;Dosage Form Design Considerations;2018

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