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Dear Group:
I have a client that is considering performing a single dose
pharmacokinetic trial on their agent in order to satisfy a regulatory
requirement. A conventional pediatric patient trial is apparently not
possible and an alternative approach is being developed.
If they attempted to perform a simplified PK study in children from 6
to 16 it may provide the necessary information to satisfy the Agency. I
am well aware of the recruitment and ethical difficulties in conducting
such a trial but am currently evaluating the possibility.
I am interested in identifying any networks, sites or collaborations
that maybe able to perform healthy volunteer pediatric studies in a
reasonable time frame or have prior experience with such studies.
Thanks for your assistance.
John
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John,
I think you will have a difficult time passing a healthy volunteer PK
trial in children with most Investigational Review Boards (IRB). Is
this drug currently being used in an off-labeled fashion in a specific
disease state/disorder? If so, it may be easier to enroll these
patients from an IRB perspective.
Carlton
Carlton K.K. Lee, Pharm.D., MPH, FASHP
Assistant Professor - Pediatrics
Johns Hopkins University
Phone: (410) 614-2949
FAX: (410) 955-9765
Pager: (410) 283-0740
email: cleea.aaa.jhmi.edu
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The Pediatric Pharmacology Research Unit Network, which we are a
member, is
comprise of 13 pediatric units specializing in pharmacology studies in
infants and children and has vast experience in phase I-II studies in
pediatric patients. However, as you appear to recognize there are
significant ethical hurdles in performing PK studies in healthy
pediatric
volunteers and except under some extraordinary circumstances this
practise
is not done (and at some centers cannot be performed at all).
Depending on
the drug being studied, it may be possible to study a pediatric
populations
at risk.
Best Regards,
Edmund Capparelli
Edmund V. Capparelli, Pharm.D.
Director, Pediatric Pharmacology Research Unit (PPRU)
Clinical Professor, Pediatrics
Division of Clinical Pharmacology and Developmental Therapeutics
Schools of Medicine and Pharmacy & Pharmaceutical Sciences
University of California, San Diego
Phone 619-497-2100
FAX 619-497-2101
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You are adviced to use urine analysis. This is what works for children
.. However there is A LOT OF EXPERIMENTAL ERRORS WITH URINE ANALYSIS
(URINE CONCENTRATION TIME CURVE)
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)