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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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?