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.|
|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|
This is to request information after reviewing the response from the sponsor in the submission dated 08/07/2009.
- For the data set named pasgrowth2.sas7bda, please answer the following questions.
- What do variables -(b)(4)---- and -(b)(4)- represent; and how they were obtained? Please explain the missing values for variables -(b)(4)---------.
- 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.
- Please check whether variables Dbl_t, Max and T_max are all normally distributed?
- Please indicate which variable is “the end of the lag phase” and how this variable was obtained?