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How important is a time zero (pre-dose) sample for a single dose
clinical PK study?
The reason I ask this is because it is a major issue in paediatric
studies, particularly single dose PK or bioequivalence/bioavailability
studies where obtaining a time zero sample may not always be feasible.
This is often because study has to be incorporated into normal
clinical practice. For example if you are evaluating an new analgesic
for trauma in an Accident & Emergency (Casualty/ER) Department, the
priority is to give the analgesic and not to wait until a cannula has
been inserted (into an already distressed child) and for the time zero
sample to be taken.
But there is of course the regulatory dilemma. If the study is pivotal
for obtaining a marketing authorisation, you would want robust data.
I would be interested to know what the view (or what you perceive to
be the view) of regulatory bodies such as the EMEA or FDA are on this.
Centre for Therapeutic Evaluation of Drugs in Children
University Hospitals of Leicester NHS Trust
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