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Dear Colleagues:
We knew that FDA guidance on bioanalytical method validation gives a
choice of using surrogate matrix in place of biological matrix for
validating analytical methods and the clinical sample analysis. I
appreciate if anyone can share with me their experiences in the use
of surrogate matrix for Aqueous Humor from Human Eye. We all aware
the Ophthalmic Aqueous Humor is hard to access and an expensive
material and doing validation in this matrix is time consuming
expensive, if someone can guide me on how they validated an
analytical method using surrogate matrix (composition of surrogate
aqueous humor) whether they used completely the surrogate matrix or
for some aspects (recovery, QCs or something) they used actual
aqueous humor?
Any guidance is highly appreciated.
Sincerely,
Prasad
--
Siva Rama Prasad Kambhampati, PhD
Section Head, Clinical Evaluation of Specialty Products
MDS Pharma Services
621 Rose Street
Lincoln, NE-68502 USA
Email: Prasad.Kambhampati.aaa.mdsinc.com
Tel: 402-437-1130
Fax: 402-476-7598
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