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RegisterAnimal PK Sample Analysis [Regulatives / Guidelines]
Dear Riteshsrmc,
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.
❝ 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.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Animal PK Sample Analysis riteshsrmc 2013-10-28 07:51
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Animal PK Sample AnalysisOhlbe 2013-10-28 12:01
Ing. Helmut Schütz