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Potency and the product life‐cycle<br />
(additional points)<br />
• The need to understand the performance of assays over<br />
time and through clinical development points to the need<br />
for maintaining stable reference preparations against<br />
which potency results may be standardized<br />
• There is also considerable value in retaining (under<br />
conditions of high stability) samples of material used<br />
during the clinical development process in order to<br />
bridge between clinical studies, for example, if the retesting<br />
of potency in updated assays becomes<br />
necessary.<br />
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