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The following message was posted to: PharmPK
Is there any American or EU guideline to be followed to be able to
obtain facilities accreditation for Pharmacokinetic Units to carry
out studies in non-patient volunteers?
Thanking you in advance
Dr. Ethel C. Feleder
Clinical Research Department Head
Osmotica Argentina S.A.
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Dear Mail sender,
regarding your question, I can answer as follows:
There is no American or EU guideline to be followed to be able to
obtain facilities accreditation for Pharmacokinetic Units to carry
out studies in non-patient volunteers. The procedure to be followed is
as follows:
- set-up and conduct of a pk study according to the ICH guidelines (with
external monitors etc.)
- audit of the study by a recognized international auditor
With that procedure the trial result must be accepted by all authorities
around the world.
We could care for such a study in our facilities.
In case of questions, don't hesitate to contact me.
Kind regards
--
Swiss Pharma Contract Ltd.
Dr. Rolf Pokorny
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