Setting CU Acceptance Criteria for Larger Sample Sizes
View Presentation Soren Andersen, Novo Nordisk Myron Diener, sanofi aventis *Gregory L Larner, Pfizer James Pazdan, Novartis Lori Pfahler, Merck Dennis Sandell, Siegfried Helen Strickland, Glaxo Kim Vukovinsky, Pfizer Keywords: Uniformity of Dosage Units (UDU), Content Uniformity (CU), Specification, Coverage Process analytical technology applications for content uniformity allow the measurement of significantly more dosage units per batch than required by traditional pharmacopeia testing. Applying the compendial requirements to samples larger than 30 is overly restrictive and leads to a disincentive to take larger samples that would contribute to increased process understanding and control. Sandell (et al) proposed a nonparametric counting test for samples greater than 100 dosage units that provides equal or better assurance of content uniformity than the compendial test. As there may be numerous manufacturing situations that would yield sample sizes of 31 to 99 per batch, this work provides appropriate tests for those moderate sample sizes.
|
Key Dates
-
April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC