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Dear all,
I kindly ask you if someone can give me an advice about a thorough QT/
QTc study, in accordance with FDA requirements: is it required that
drug plasma levels assay, to establish systemic exposure, is carried
out blinded in the bioanalytical labs ?
Or blinding may be open at the analytical lab and only samples of
subjects administered with active treatment can be analysed
Many thanks and kind regards
Annalisa Piccinno
Drug Metabolism & Pharmacokinetics Department
mailto:a.piccinno.aaa.chiesigroup.com
http://www.chiesigroup.com
Chiesi Farmaceutici S.p.A. Via S. Leonardo 96 43100 Parma (ITALY)
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The following message was posted to: PharmPK
Only samples of subjects administered with active treatment are
analysed.
Yaning
Yaning Wang, Ph.D.
Team Leader, Pharmacometrics
Office of Clinical Pharmacology
Office of Translational Science
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Email: yaning.wang.aaa.fda.hhs.gov
"The contents of this message are mine personally and do not necessarily
reflect any position of the Government or the Food and Drug
Administration."
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