Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
U.L.<br />
Potency<br />
L.L.<br />
Calculation of vaccine minimum<br />
release potency<br />
•For vaccines, we usually set a minimum release spec to<br />
assure mean potency exceeds a clinically acceptable lower<br />
limit (L.L.) throughout the shelf life<br />
Release spec<br />
} Error term<br />
Time<br />
Expiry<br />
} Expected stability loss<br />
based on stability studies<br />
(linear regression, when<br />
feasible)
Change language