Dear Pharm PKers,Back to the Top
I am interested to work in the in vitro estimation of drug and the
metabolic changes.
1. How to perform the microsomal industion and inhibition assays
2. How to correlate the invitro results with invivo (Plasma or serum PK
data)
3. Why GC-MS was not employed as like LC-MS and any regulatory reason
if any?
I will be thankful for your answers.
Yours truly,
Kas
Dear Kas,Back to the Top
Your question is very wide!
To start, you can have a look on the FDA guidance (Guidance for
Industry:
Drug Metabolism/Drug Interaction Studies in the Drug Development
Process:
Studies In Vitro), and on the following general articles:
1) Tucker GT et al, Pharm. Res., 18, 1071-1080 (2001)
2) Bjornsson TD et al, J. Clin. Pharmacol., 43, 443-469 (2003).
Regards,
Frederic Massiere
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