Pharmaceuticals

Non-clinical safety testing

Regulation (EC) No. 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency VUOS has experience with safety toxicological testing for pharmaceuticals. All studies are performed in compliance with Good Laboratory Practice (GLP) regulations. All common test systems (in vitro, in vivo, ex vivo) and common administration routes are offered.

Single-Dose Toxicity: ICH M3(R2), EMEA/CHMP/SWP/81714/2010 

• Acute toxicity 
• Extended single dose toxicity 
• Maximum tolerated dose

Repeated-Dose Toxicity: ICH M3(R2), ICH S4, CPMP/SWP/1042/99, CPMP/ICH/300/95 

• 14-day repeated dose toxicity 
• 28-day repeated dose toxicity 
• 90-day repeated dose toxicity 
• 6-month repeated dose toxicity

Genotoxicity: ICH S2(R1), ICH S2A, ICH S2B 

• Reverse mutation test using bacteria 
• In vitro mammalian cell micronucleus test 
• In vitro mammalian chromosome aberration test 
• In vitro mammalian cell gene mutation test 
• In vivo mammalian erythrocyte micronucleus test 

Carcinogenicity: ICH S1C(R2), ICH S1A, ICH S1B, ICH S1C(R2) 

• Carcinogenicity study 
• Combined chronic toxicity/carcinogenicity study 

Reproductive and Developmental Toxicity: ICH S5(R2), EMEA/CHMP/203927/05 

• Prenatal developmental toxicity 
• One-generation reproduction toxicity 
• Two-generation reproduction toxicity

Local Tolerance: CPMP/SWP/2145/00 

• In vitro skin corrosion: human skin model test 
• In vitro skin irritation 
• Acute toxicity: dermal irritation/corrosion 
• Acute toxicity: eye irritation/corrosion 
• Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants 
• Local lymph node assay 
• Guinea pig maximization test 
• Other special tests according to the CPMP/SWP/2145/00