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Hello every one,
While calculating the Matrix factor, what should be the Ideal
acceptance?
With Regards,
Falguni Patel
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Dear Falguni,
Different industries are following different criteria for
acceptance.As for as my concern prepare external spiked QCs(at
Low ,Mid & High level) in 6 different lots including one hemolysed and
compare it with aqs equivalent QCs .Find out matrix factor by dividing
area ratio of Ext. spiked QC to area ratio of AQS equivalent QCs.
global %CV of this ratio should be within 15%.
Hope this will help you.
Regards,
Rahul Vats
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The following message was posted to: PharmPK
The key feature is the precision of the MF across at least six different
biological matrices. CVlim is suggested as 15% for instrumental
assays and
may be opened up for ligand based assays. There really isn't any
absolute
value of MF, although you should try to maximize MF during development.
See the article below
Themed Issue: Bioanalytical Method Validation and Implementation: Best
Practices for Chromatographic and Ligand Binding Assays
Guest Editors - Mario L. Rocci Jr., Vinod P. Shah, Mark J. Rose,
Jeffrey M.
Sailstad
Key Elements of Bioanalytical Method Validation for Small Molecules
Submitted: February 7 , 2007 ; Accepted: March 8 , 2007; Published:
March
30, 2007
Surendra Bansal 1 and Anthony DeStefano 2
1 Hoffman-LaRoche Inc, Nutley, NJ
2 Procter & Gamble Pharmaceuticals, Mason, OH
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Dear Falguni,
As per our laboratory practice Matrix factor should be between 0.9 to
1.1 to avoid the assay variability.
However, no guideline defines the acceptace criteria for Matrix factor
As per AAPS article (Surendra Bansal) the %CV of ISTD normalised
matrix factor for 6 different lot of matrix should be within 15%
Regards
Raghavendra Shetty
Ecron AcuNova Ltd
Manipal
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