Saturday, February 21, 2009

Good Cell Culture Practices, GCCP, in Non Clinical In Vitro Safety Studies

Basic In Vitro Non Clinical Testing regulations
-21 CFR 58 - GLP
-40 CFR 162 - FIFRA
-40 CFR 792 - TSCA
-ENV/MC/Chemical (98) 17 Section No. 1-15
-21 CFR 210/ 211; 820

Alternative Animal Studies Expansion
Replace, reduce, and refine
-Modeling of in vitro systems to correlate with in vivo data
-Identification of cell line
-Qualification of test model
.Within a lab
.Data is reproducible and designed for specific cellular outcome
-Validation of model
.Inter lab studies

GCCP In Vitro NonClinical Safety Testing

In Vitro Safety Studies Examples
-USP Elution Assay
-3D dermal tissue models
-CaCo 2 cells
In Situ Safety Studies
-Viral/ Gene / Receptors markers

Increased in vitro models for toxicity
Increased submission of data from in vitro models for xenobiotic toxicity profiles
Increased use of cells lines
Controlling variation between laboratories using similar models
Acceptance of data; harmonization

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