Katherine et.al.:

To confirm the information contained in the attached responses:

Refer to the 1987 FDA 'Guideline on Validation of the Limulus Amebocyte
Lysate Test as an End-Product Endotoxin Test for Human and Animal
Parenteral Drugs, Biological Products, and Medical Devices'. On page 22
Appendix D for the dose you will see: ..."if the pediatric dose/kg is
higher than the adult dose then it shall be the dose used in the formula".

Jeff Werner
V-P, PMF and
Steering Cmte Member LAL Users Group





"Shih, Katherine" <[log in to unmask]> on 10/01/98 07:38:41 PM

Please respond to The Pharmaceutical Microbiology Mail List
      <[log in to unmask]>

To:   [log in to unmask]
cc:    (bcc: Jeff Werner/Cambridge/Biogen)
Subject:  Re: [PMFLIST] Endotoxin Limits




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Michael:
Thank you.  (Your memory serves you right.)
Katherine Shih
> -----Original Message-----
> From: MICHAEL CARROLL (Sr. QA Mgr., Osteotech, Inc.
> [SMTP:[log in to unmask]]
> Sent: Thursday, October 01, 1998 11:38 AM
> To:   [log in to unmask]
> Subject:      Re: [PMFLIST] Endotoxin Limits
>
>      Katherine:
>         The only exceptions to the 5.0 EU/Kg rule that I'm aware of,
> are
>      intrathecals, which (if memory serves) are 0.2 EU/Kg..... I
> believe
>      the "per Kg" part is supposed to account for pediatrics: Smaller
> body
>      mass--
>         M.Carroll ([log in to unmask])
>
>
> ______________________________ Reply Separator
> _________________________________
> Subject: [PMFLIST] Endotoxin Limits
> Author:  <[log in to unmask]> at INTERNET-MAIL
> Date:    9/29/98 11:31 AM
>
>
> Hi:
>
> We use 5 EU/Kg as the endotoxin limit for parenteral products.  Is
> there
> a lower limit for pediatric products?   Are children/infant more
> sensitive?  Thank you in advance for your help.
>
> Katherine Shih
> Oread
> >
>
>
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