2 results
Approved WMOCompleted
To obtain the safety and effectiveness data necessary to support a Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA)
Approved WMOCompleted
The primary objective is to minimize the occurrence of sub-therapeutic and supra-therapeutic C0 of tacrolimus on day 3 after transplantation by basing the starting dose of tacrolimus on a dosing algorithm, rather than the standard bodyweight-only-…