
3/31/2008 Email - Rotarix


 

 
From: Henchal, Laraine 

Sent: Monday, March 31, 2008 1:37 PM 

To: 'Donna.2.Boyce@gsk.com' 

Subject: Potency release spec 

Yes, looks like we will have release potency between ------- (including those values; so ---------------------------------------------------------- at release). End-expiry OK at ---, but with a 24 month dating period for now. With the drop-off on the numbers at -- months, we would like to see further stability data -------------------------------, which can be done with supplement. 24 months may even be enough for you ------------------------------------------------------... So the release criteria will need to be reflected in an amended lot release protocol...I know that Joe Quander had some format questions for you earlier.

Laraine S. Henchal, MAS
 Microbiologist Reviewer, Team Leader
 Viral Vaccines Branch
 Division of Vaccines and
 Related Products Applications
 Office of Vaccines Research and Review
 Center for Biologics Evaluation and Research
 Food and Drug Administration
 Phone: 301-827-3070
 Fax: 301-827-3532

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From: Donna.2.Boyce@gsk.com [mailto:Donna.2.Boyce@gsk.com] 

Sent: Monday, March 31, 2008 11:58 AM 

To: Henchal, Laraine 

Subject: welcome back 

Hi,

Hope you had a nice holiday..do you have any updates regarding the potency spec for me?

best regards,
 Donna
