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