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Regulatory Guidelines


OECD
Schedule Y
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Tests Required


Toxicology
  Acute studies 14 day Dose range finding studies  
Sub-acute studies Sub_chronic studies  
Genotoxicity
Others
 
   
GLP Non GLP  
Pharmacology
     
  Efficacy Models Pharmacokinetics  
Transgenic Models
Others
 
Batch release pharmacopeia
  Pyrogen testing Abnormal toxicity  
Others
 
     
Biocompatibility
Primary skin irritation Dermal sensitization
Cytotoxicity Implantation studies (1wk, 2wk, 4wk, 12wk)
Bacterial reverse mutation assay In-vitro chromosomal aberration test
In-vivo chromosomal aberration test In-vivo micronucleus test
Others
GLP Non GLP  
Alternative TGs for cosmetics
  In-vitro skin models HET - CAM  
BCOP
Others