USP Responses to Comments on Stimuli Article, "Proposed Change to Acceptance Criteria for Dissolution Performance Verification T

ABSTRACT
Pharmacopeial Forum 33(3) [May–June 2007] included a Stimuli article titled “Proposed Change to Acceptance Criteria for
Dissolution Performance Verification Testing.” This Stimuli article proposed changing the form of the acceptance criteria
for the Performance Verification Test (PVT) associated with USP Dissolution <711> to make the PVT consistent with the
International Organization for Standardization’s recommendations for proficiency testing. The article elicited five
comments, which are abstracted here with USP responses.
INTRODUCTION
In Pharmacopeial Forum 33(3) USP authors published a
Stimuli article titled “Proposed Change to Acceptance
Criteria for Dissolution Performance Verification Testing”
(1). This article elicited a number of comments, which are
published here with USP responses. Comments have been
edited for publication.

Author(s): 
Walter W. Hauck, Todd L. Cecil, William Brown, Darrell R. Abernethy, William F. Koch, Roger L. Williams
Journal: 
Dissolution Technologies May 2008 Volume 15 Issue 2