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October 1998

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The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Sat, 10 Oct 1998 18:11:03 EDT
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To the best of my knowledge there is no difference in the endotoxin
sensitivity of children.  The FDA guideline does not differentiate between
adult and pediatric uses except when the drug dose per Kg is calculated.  If
the pediatric dose per Kg is higher than the adult dose the pediatric dose is
used to calculate the endtoxin limit for the product.

Terry E. Munson
KMI/Parexel


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