System Info - 114310 SMITH, MICHAEL J 17-Dec-2009 16:08:22 SMITHM
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125324/0 Office: OVRR
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 17-DEC-2009 11:41 AM Initiated by FDA? Yes
Author: MICHAEL SMITH
Recommendation for future validation methods for PnELISA's.
FDA Participants: Mike Smith, Julie Vaillancourt and Colleen Sweeney
Non-FDA Participants: Jack Love and Carmel Devlin
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Smith, Michael (CBER)
Sent: Thursday, December 17, 2009 11:41 AM
To: 'Love Jack'; 'Devlin Carmel'
Cc: Vaillancourt, Julienne; Sweeney, Colleen
Subject: RE: Comment from Dr. Lev Sirota regarding the bioassay statistical review
Jack and Carmel,
Dr. Lev Sirota completed his statistical review of the bioassays and there is one comment (see below) regarding any potential future validation assays.
- In the Pneumococcal Enzyme-linked Immunosorbent Assays (PnELISAs) sub-section of section 188.8.131.52 “Analytical and Bioanalytical Methods” you used a criterion for linearity of R>(b)(4). This criterion appears to be too liberal. All presented linear regression data in this part of study demonstrate a coefficient of correlation of 0.99 and above. CBER recommends that you make criterion more stringent for future validations of the method. Please comment.
If you have any questions, please contact Julie or myself.
Mike Smith, Ph.D.
Lieutenant Commander (LCDR), U.S. Public Health Service
Regulatory Project Manager
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
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