Optimization of a pharmaceutical freeze-dried product and its process using an experimental design approach and innovative process analyzers-Reference-Cited by-同舟云学术

Optimization of a pharmaceutical freeze-dried product and its process using an experimental design approach and innovative process analyzers

Published:2011-02 Issue:5 Volume:83 Page:1623-1633
ISSN:0039-9140
Container-title:Talanta
language:en
Short-container-title:Talanta

Author:

De Beer T.R.M.,Wiggenhorn M.,Hawe A.,Kasper J.C.,Almeida A.,Quinten T.,Friess W.,Winter G.,Vervaet C.,Remon J.P.

Publisher

Elsevier BV

Subject

Analytical Chemistry

Reference18 articles.

1. Guidance for Industry: PAT – a Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, U.S. Food and Drug Administration, September 2004 (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070305.pdf).

2. Impact of freezing procedure and annealing on the physico-chemical properties and the formation of mannitol hydrate in mannitol–sucrose–NaCl formulations

3. Development of HSA-free formulations for a hydrophobic cytokine with improved stability

4. Importance of Using Complementary Process Analyzers for the Process Monitoring, Analysis, and Understanding of Freeze Drying

5. Building quality into a coating process

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