Dear Pharm PKers,Back to the Top
I am interested to work in the in vitro estimation of drug and the
1. How to perform the microsomal industion and inhibition assays
2. How to correlate the invitro results with invivo (Plasma or serum PK
3. Why GC-MS was not employed as like LC-MS and any regulatory reason
I will be thankful for your answers.
Dear Kas,Back to the Top
Your question is very wide!
To start, you can have a look on the FDA guidance (Guidance for
Drug Metabolism/Drug Interaction Studies in the Drug Development
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).
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