Table of Contents
Biotechnology Industry Organization (BIO)
BIO Membership
Spectrum of medical products
Paradigm for risk assessment
CASE by CASE approach
From science to new medicines
Differential impact
“What is an ideal safety database?”
PPT Slide
Long-term, controlled safety studies
A diverse safety database
Diverse database: impact on safety
Different dose levels
Data analysis and presentation
Identification safety issues early
Conclusion
On behalf of BIO:
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