Bioequivalence and Bioavailability Forum • Animal PK Sample Analysis

riteshsrmc
☆

India,
2013-10-28 08:51
(4622 d 09:15 ago)

Posting: # 11787
Views: 2,600

Animal PK Sample Analysis [Regulatives / Guidelines]

Hi,

Can you pl. someone respond to the following query?

If Pre-clinical studies (Life Phase) being conducted at CRO (GLP Certified) and PK samples from that CRO is being analyzed at a Bioanalytical CRO (Not GLP Certified but comply with GLP). So

Whether It would be acceptable by Regulator(s). Since Bioanalytical CRO does not have GLP certification?
As far as I beleieved that Bioanalytical CRO does nor comes under National GLP compliance Programme? (Is it right)?
Whether Bioanalytical CRO can be audited by National GLP compliance Programme?

Early response would be highly appreciate.

Ohlbe
★★★

France,
2013-10-28 13:01
(4622 d 05:05 ago)

@ riteshsrmc
Posting: # 11791
Views: 2,083

Animal PK Sample Analysis

Post reply

Dear Riteshsrmc,

❝ If Pre-clinical studies (Life Phase) being conducted at CRO (GLP Certified) and PK samples from that CRO is being analyzed at a Bioanalytical CRO (Not GLP Certified but comply with GLP).

This depends on the scope of your study. If it is just a PK study: no problem, it does not formally fall in the scope of GLP. If it is a preclinical safety study with some toxicokinetic samples: it is fully in the scope of GLP, and the bioanalytical lab should be GLP-compliant. If they are not part of a routine national GLP monitoring programme they should contact the monitoring authority and ask for an inspection.

—
Regards
Ohlbe