
Statistical Review and Evaluation Letter - Intersol, August 18, 2009
 

 
STATISTICAL REVIEW AND EVALUATION



Date of the review:
8/18/09 

Type of submission:
BN_080041 

Product/Application:
New drug application: InterSol Solution for storage of AMICUS-Derived Apheresis Platelets. 

Indication: 
The InterSol Solution is a plasma replacement fluid for storage of platelet using routine blood banking conditions. Platelet products stored in InterSol are transfused to patients with low platelet counts or to decrease bleeding. 

Sponsor:
Fenwal Inc. 

From:
Paul B. Hshieh, Ph.D. 

Through:
Ghanshyam Gupta, Ph.D.,Chief, Therapeutics Evaluation Branch, (HFM-219)/Tie-Hua Ng, PhD., Team leader, Therapeutics Evaluation Branch,(HFM-219). 

To:
Salim Haddad, Medical officer. 

 


cc:
 HFM-219/ Ghanshyam Gupta  

 
HFM-215/ Henry Hsu  

 
HFM-215/Chronnological File 

Note:

This is to request information after reviewing the response from the sponsor in the submission dated 08/07/2009.
1.For the data set named pasgrowth2.sas7bda, please answer the following questions. 1.What do variables -(b)(4)---- and -(b)(4)- represent; and how they were obtained? Please explain the missing values for variables -(b)(4)---------.
2.Please correct some mistakes for variables Max and T_max. For example, with Bug=-(b)(4)- Donor=8, Media=PAS-, Max and T_max are incorrect; please double check the values of these two variables.

2.Please check whether variables Dbl_t, Max and T_max are all normally distributed?
3.Please indicate which variable is “the end of the lag phase” and how this variable was obtained?
