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Zoekresultaten - 6 results
The consistency approach for the substitution of in vivo testing for the quality control of established vaccines: practical considerations and progressive vision
FOS Classification: 1.6 Biological sciences ...
Setting specifications for Biologicals. Points to consider from simple to complex. Case study for viral vectored vaccines.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, BioMAN, Issue BioMAN, Cambridge, MA, USA (2017) Keywords: vaccine Health Topics: Va ...
Panel discussion on specifications for biologicals
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, BioMAN, Issue BioMAN, Cambridge, MA, USA (2017) Keywords: vaccine Health Topics: Va ...
The Biological Standardisation activities at the international level
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Quality control and batch release of vaccines and blood products in Europe, WIV-ISP, Issue WIV-ISP, Brussels, Belgium (2015) Keywords: Activity at batch release ...
Stability of Staphylococcus aureus Phage ISP after Freeze-Drying (Lyophilization)
Classification: 1.6 Biological sciences ...
Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).
on animals is only required for pre-clinical studies in order to test the toxicity of the drug substance and not for routine batch release. However, for some biological medicinal products in general ...