Hi,
I want pharmacokinetic data (Plasma conc. vs time) of certain drugs to build physiologically based pharmacokinetics models. How can I find such data for the studies listed in clinicaltrials.gov? In the results sections, only the pharmacokinetic parameters extracted from that data is given.
Dear Muhammad ,
Only some trials are published. Unfortunately until now most of studies are not available for example in PubMed. Of course if some studies are published then available data cover final PK parameters not raw data.
Best regards
Tomasz
Thank you, Dr. Tomasz. So, can i compare the predicted values of the pharmacokinetic parameters with the experimental values for the validation of the model?
Dear Muhammad
Its depends on your goal, model and data, of course predicted versus observed is basis of any validation procedure.
Best regards
Tomasz
Dear Muhammad,
As mentioned by Tomasz not all trial are published and often papers show elaborated results rather than data. You can search for the papers, they may have supplementary data files with more of the data.
If the studies you are interested in were part of a submission to EMA for an approved drug (look in EPAR documents) you can place a request for document access, see instructions at this link:
https://www.ema.europa.eu/en/news/regulatory-information-ema-releases-practical-guidance-access-documents-requests
Some Sponsors also have disclosure policies for their clinical data.
Best regards
Patrice
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