The safety testing of pharmaceutical products, such as antibody, recombination protein, vaccines and peptide drugs are required for the evaluation of toxic effects. This testing mainly focus on toxicological investigations.
In regulatory terms, safety studies encompass:
- safety pharmacology
- acute toxicity
- subchronic/chronic toxicity
- genotoxicity
- carcinogenicity
- reproductive toxicity
- special toxicity
When design a safety testing, some principles should be considered carefully. These aspects include the selection of test system (animal species, cell or bacterial strains), conditions for test systems, test size and selection of concentrations and doses. Our technical staffs are experienced in safety and toxicology evaluation of different biopharmaceutical products. Creative Proteomics provides following various safety testing based on United-States Pharmacopoeia and ICH Guidelines:
- general toxicity studies
- single dose acute toxicity studies
- repeated dose toxicity studies
- reproductive toxicity studies
- genotoxicity studies
For more details about our services, please contact us.
