|
Activity Number:
|
246
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Tuesday, August 8, 2006 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #305913 |
|
Title:
|
Statistical Issues of Two-Stage Delivery Dose Uniformity Test of Orally Inhaled and Nasal Drug Products
|
|
Author(s):
|
Meiyu Shen*+ and Yi Tsong
|
|
Companies:
|
U.S. Food and Drug Administration and U.S. Food and Drug Administration
|
|
Address:
|
10903 New Hampshire Ave., Silver Spring, MD, 20993,
|
|
Keywords:
|
dose content uniformity ; inhaler product ; parametric tolerance intervals ; quality assurance
|
|
Abstract:
|
In response to the 1998 FDA Draft Guidance for Chemistry, Manufacturing and Controls (CMC) documentation for metered dose inhalers (MDIs), dry powder inhalers (DPIs) and nasal spray drug products, pharmaceutical companies and industry groups have submitted numerous comments on the target specifications of the delivery dose and the validity of the delivered dose uniformity (DDU) test. These comments mainly focused on the unnecessary degree of restrictions and the statistical bias of the test procedure. In the last five years, both FDA and the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) have actively worked on developing an improved statistical testing procedure. In this presentation, we discuss the deficiencies of the 1998 FDA Draft Guidance test and a group sequential test procedure based on parametric tolerance intervals (PTT).
|
