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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>

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