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The following message was posted to: PharmPK
Dear All,
I would like to know about use of "radioimunoassay" in bioequivalence
studies.
In these protocols, Should the validation data contain evaluation of
linearity, quality controls, precision ... equal to a chromatography
validation ?
There are any draft or guidance that has this explanations.
Thanks,
Daniel
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The following message was posted to: PharmPK
Dear Daniel,
There are a guidance for Industry called "Bioanalytical Method
Validation"
that you can find in this electronic address:
http://www.fda.gov/cder/guidance/4252fnl.pdf
I hope it helps you.
Best regards,
Daniel Martínez
RIA Laboratory
Metabolism & Pharmacokinetics Service
Research & Development Department
IPSEN PHARMA, S.A.
Ctra. Laureŕ Miró 395
Sant Feliu de Llobregat, Barcelona, Spain
Teléf.: 936858100
daniel.martinez.aaa.beaufour-ipsen.com
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