Module 9 2024
03/09/2024
Prophylactic Vaccines & Pharmaceuticals: Different Purposes
Vaccines
Pharmaceuticals
Protect Healthy individuals
Treat ‘ sick ’ Patients
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Why are Vaccines Different? Considerations for registration….
Usually administered to very large numbers of healthy people , often infants, in national immunization programs; thus safety and quality are paramount *
Biological (inherently variable)
•
• Raw materials may also be biologicals • Biological methods used to test (standardisation difficult) • Range of different technologies used • Often combinations of antigens
The Organisation for Professionals in Regulatory Affairs
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