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Potency and product life cycle<br />
• Each progressive phase of development is based upon<br />
an ability to relate their respective measures of potency.<br />
• Doses used in Phase 1 studies must be capable of<br />
being related to those used in pre-clinical studies<br />
• In turn, doses used in Phase 2 and Phase 3 studies<br />
must be capable of being related both to each other and<br />
to material used in Phase 1.<br />
• After licensure, potency assays are used to help assure<br />
that marketed product contains a quantity of active<br />
ingredient similar to that shown to be safe and effective<br />
in clinical trials.<br />
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