Targeted development of biosimilar pharmaceutical products
Targeted development of biosimilar pharmaceutical products
Targeted development of biosimilar pharmaceutical products
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Quality Attribute Criticality Assessment<br />
A-Mab case study risk assessment tool #1:<br />
Risk ranking & filtering<br />
Criticality = Impact (2-20) × Uncertainty (1-7)<br />
Risk that an attribute<br />
impacts safety and<br />
efficacy (risk score)<br />
Known or potential<br />
consequences on safety<br />
and efficacy, considering:<br />
• Biological activity<br />
• PK/PD<br />
• Immunogenicity<br />
• Safety<br />
Risk scores range between 2 and 140 (criticality continuum)<br />
22 | Thomas Stangler | EAPB SIG Regulatory Aspects for Bio<strong>pharmaceutical</strong>s | October 4th, 2010 | Business use only<br />
Relevance <strong>of</strong> information<br />
e.g. literature, prior knowledge,<br />
in vitro, preclinical, clinical
![Roy Forster [Kompatibilitätsmodus]](https://img.yumpu.com/7737040/1/190x135/roy-forster-kompatibilitatsmodus.jpg?quality=85)
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