PharmPK Discussion - Metabolite elucidation in tox species

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On 26 Nov 2003 at 15:32:55, "Hoefer, Constance" (Constance.Hoefer.-at-.solvay.com) sent the message


The following message was posted to: PharmPK

Dear All,

Does anyone have information relating to regulatory requirements for
metabolite ID ALSO in faeces and urine (in addition to plasma) in all
tox
species employed (rat, dog, hamster, mouse) if there is good evidence
(from
cold studies) that the plasma metabolite profile of only one tox species
(dog) is comparable to that of man?

Many Thanks for your help,

Constance

Dr Constance Hoefer
Department of Clinical Candidate Selection
PH-REB
Solvay Pharmaceuticals GmbH
Hans-Boeckler-Allee 20
30173 Hannover, Germany
Phone +49 (0)511 857-3365
Fax     +49 (0)511 857-3269
Mail to Constance.Hoefer.-at-.solvay.com

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