PharmPK Discussion - Dose for Linearity/Non-Linearity

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On 30 Nov 1998 at 12:54:07, "R. C. GUPTA" (rcgupta.at.usa.net) sent the message


Hi!

We are doing pre clinical pharmacokinetic studies of new chemical entity
whose oral dose in rats 72 mg/kg.  What dose should be used to determine
linearity/non-linearity in pharmacokinetics? Kindly also provide relevant
references.

R. C. Gupta
rcgupta.-a-.usa.net

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On 1 Dec 1998 at 10:47:03, "Wagner, Bertil K {PDRD~Nutley}" (BERTIL_K.WAGNER.at.roche.com) sent the message


Dear R.C. Gupta,

The dose used in initial human studies is 1/10 the MTD. I would suggest
that you cover at least that dose up to the anticipated human dose range
based on available pre-clinical data.

Bertil Wagner, Pharm.D., FCCM
Pharma Development Registration
Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley, NJ 07110
(973) 562-5515

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