Can any one provide me a standard PK/PD protocol . for small molecule/ peptide?
Hi, as per my knowledge..there shd be nothing like a standard PK/PD protocol. You have to design yourself based on the molecule (small/large), may be you can first go through some available studies of other molecules of similar class to have an idea about Tmax and Half-life to fix the time-points.. Although the PK properties of your molecule can be quite different from the same class, but you can use the results from your initial study, to plan a throrough study later on or integrate other parameters along with.
Varun Ahuja If I may ask, would you mind sending me few good reads to begin with? thanks.
Anukana Bhattacharjee kindly inform what are you working with small/large molecule, and better to provide some precise details. So, that I can send you relevant info.
Anukana Bhattacharjee You can google 'Drugs@FDA' or go to following link:
-https://www.accessdata.fda.gov/scripts/cder/daf/
-Search for any drug and download its pharmacologic review, in which section 5 contains PK-studies. Go through that, and design your study.
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