Hello Vivian:
As suggested, I am posting your response to the post mentioned above, along with an Editorial note from myself. Regards. Saeed
Editorial Note:
To address this response, I would like to clarify that I was referring to a potentially diminished role in the future in my post. Also, I assume that your comments reflect your personal views and not those of the USP or the new Expert Advisory Committee.
Response:
Dear Saeed, I feel I have to respond your recent posting on your website about Changes at USP. Please be sure you have seen the article in the August issue of Dissolution Technologies that gives the make up of the new USP committee. This information in is the USP update with Tom Foster achieving the Beal award. In that article the new members of the new committee are listed. There are five members of the BPC committee that are now on this new committee. They are Mario Gonzalez, Johannes Kramer, Tom Foster, Alan Parr and I. These people were very much involved with the PVT and I can assure you that the work will continue in the new committee and at the USP labs. The USP has published many articles in Pharmacopeial Forum (PF) about the PVT and evaluations of variables using the Prednisone Standard Tablets. Also if you look in Dissolution Technologies (DT), www.dissolutiontech.com back issue there are a plethora of articles on the dissolution variables and the USP Prednisone Tablets. Also in DT we have reprinted many of the PF articles about the PVT and the new criteria. So the “absence of clear information” is not accurate. If you go to the USP website there are many places for information on the subject including the USP Tool Kit on mechanical calibration. As a point of interest, the PF will be available on line for free in 2011.
I was hoping that I could respond on your website but the comments are closed. Please consider posting my reply to you in this public forum.
Best regards, Vivian
9 Yorkridge Trail
Hockessin, DE 19707 USA
Tel. 302-235-0621
Fax 443-946-1264
vagray@rcn.com
www.vagrayconsulting.net
www.dissolutiontech.com (now searchable, check it out)