• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

08/18/ 2008 Email - RiaSTAP

From: Kumar, Vasantha
Sent:

Monday, August 18, 2008 12:04 PM

To: 'David.Desris@cslbehring.com'
Subject: RE: STN.125317/0.CSL Behring. Human Fibrinogen Concentrate, Pasteurized. Riastap

Dear David,

Thanks for the response!

I just wanted to remind you that the data should consists of plasma concentrations vs time, individual pK parameters, dose, gender, age and weight.

Thanks Vasantha

Vasantha Kumar, M.S., Ph.D.
FDA/CBER/OBRR/DBA/RPMB
Room 485N/HFM-380
1401 Rockville Pike Rockville, MD 20852
Phone: 301-827-3524 Fax: 301-827-2857
E-Mail:  vasantha.kumar@fda.hhs.gov

 

 From: David.Desris@cslbehring.com [mailto:David.Desris@cslbehring.com] 
Sent:
Friday, August 15, 2008 2:56 PM 
To:
Kumar, Vasantha 
Subject:
RE: STN.125317/0.CSL Behring. Human Fibrinogen Concentrate, Pasteurized. Riastap

Dear Vasantha

I have requested the PK data in an Excel format and will get back to you next week on how soon we can provide this to you. David

 

From: Kumar, Vasantha [mailto:Vasantha.kumar@fda.hhs.gov] 
Sent:
Friday, August 15, 2008 2:07 PM 
To:
Desris, David US/KOP; Hill, John US/KOP 
Subject:
STN.125317/0.CSL Behring. Human Fibrinogen Concentrate, Pasteurized. Riastap
Importance: High

Hi David and John,

I had a request from the PK reviewer to request you to provide raw plasma concentration/time data in an Excel format. I would appreciate it very much if you could provide your response at the earliest.

Thanks Vasantha

 Vasantha Kumar, M.S., Ph.D.
FDA/CBER/OBRR/DBA/RPMB
Room 485N/HFM-380
1401 Rockville Pike Rockville, MD 20852
Phone: 301-827-3524 Fax: 301-827-2857
E-Mail:  vasantha.kumar@fda.hhs.gov

This email, including any attachments, is confidential and contains proprietary content and may be legally privileged. This transmission is intended only for the designated recipient(s), and any duplication or distribution, in any form or part, without the written consent of the sender is strictly prohibited. These confidentiality protections apply even if you received this transmission in error, in which case you should delete the message, disregard its contents and notify the sender of the mistake. CSL Behring