FDA
-21 CFR 58 - GLP
EPA
-40 CFR 162 - FIFRA
-40 CFR 792 - TSCA
OECD
-ENV/MC/Chemical (98) 17 Section No. 1-15
GMP
-21 CFR 210/ 211; 820
Alternative Animal Studies Expansion
-R’s
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
-Photo-toxicity
-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
No comments:
Post a Comment