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Dissolution Method Validation and Method Transfer
Tuesday, November 13
7:00 am - 8:15 am
Sunrise Session
ACPE #073-999-07-515-L04
This sunrise school will cover in depth, the method validation parameters for dissolution testing. The aspects will be the usual validation parameters and those special to dissolution testing. Some special parameters as filter and sinker validation will be included along with deaeration and robustness. The intermediate precision will get special attention as it is a prelude to method transfer. Method transfer in dissolution test procedures can sometimes be quite troublesome and at times unsuccessful. The sources of problems in method transfer and intermediate precision will be discussed.
Moderator
Vivian A. Gray
V. A. Gray Consulting, Inc.
Dissolution Method Transfer, Including Sources of Problems
Vivian A. Gray
V. A. Gray Consulting, Inc.
Dissolution Method Validation
Margareth Marques, Ph.D.
U.S. Pharmacopeia