QbD implementation and Post Approval Lifecycle Management (PALM)-Reference-Cited by-同舟云学术

QbD implementation and Post Approval Lifecycle Management (PALM)

Published:2016-09 Issue:5 Volume:44 Page:332-340
ISSN:1045-1056
Container-title:Biologicals
language:en
Short-container-title:Biologicals

Author:

Ohage Ettore,Iverson Raquel,Krummen Lynne,Taticek Ron,Vega Maria

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference10 articles.

1. ICH harmonized tripartite guideline, pharmaceutical development;International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use,2009

2. ICH harmonized tripartite guideline, pharmaceutical quality;International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use,2008

3. ICH harmonized tripartite guideline development and manufacture of drug substances;International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use,2012

4. Determination of critical quality attributes for monoclonal antibodies using quality by design principles;Nadja;Biologicals,2016

5. Process characterization and design space definition;Christian;Biologicals,2016

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