Regulatory Aspects of Impurities in Biological Products - IIR
Regulatory Aspects of Impurities in Biological Products - IIR
Regulatory Aspects of Impurities in Biological Products - IIR
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Where is it written?<br />
Presentation Outl<strong>in</strong>e<br />
Classification <strong>of</strong> impurities <strong>in</strong> biological products<br />
Focus on ICH Q6B<br />
Example Approach to support<strong>in</strong>g Specifications<br />
for Process Related <strong>Impurities</strong>