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Dear all,
Is it mandatory for preclinical ADME studies (other than
toxicokinetics) supporting FIM to be GLP? Do ADME data (rodent, non
rodent) obtained with cold material during candidate profiling can
support IND/IMPD submission ? Do classical extended 14C ADME studies
(rodent, non rodent) be performed in parallel of phase I studies ?
Thank you in advance
Elmer PhD
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The following message was posted to: PharmPK
Dear Elmer,
ADME studies are not required, but there is no reason to exclude cold
experiments. Often, radiolabel is not made until PK in man is obtained,
since this is a large investment for biotech. So yes, these studies can
be initiated post FIM.
Hope this helps.
Joyce
Joyce James, PhD
DMPK
Ambit, Inc.
4215 Sorrento Valley Blvd.
San Diego, CA 92121
p: 858-334-2186
f: 858-334-2192
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The following message was posted to: PharmPK
Dear Seb
Distribution studies are not required by the authorities before Phase
1 but sometimes useful to demonstarte exposure in pharmacological or
toxicological target organs. It is sufficient to look at a few
important organs. ADME must be complete before Phase 3, and some data
should be available before Phase 2 (e.g. rodent mass balance and
distribution studies).
GLP for ADME is not required all cases but recommendable. If you base
any safety evaluations of your ADME data , the studies should be
performed under GLP. However, this does not apply to "voluntary" work
before Phase 1.
best regards,
Michael
--
Dr. Michael Gassen - gassen.michael.aaa.rcc.ch
Head of Animal Metabolism and Pharmacokinetics
RCC Ltd - Zelgliweg 1 - CH-4452 Itingen - Switzerland
Tel +41 61 975 1349 - Fax +41 61 971 5266
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