Studies carried
out - Pharmaceuticals & Medical Devices
Non-clinical toxicity studies (ICH
guidelines EU, USA & Japan)
Single / Repeated dose toxicity studies
Reproduction toxicity studies
Genotoxicity studies
Local tolerance / Toxicokinetic studies
Pharmacokinetic studies
Medical Devices - Biocompatibility
(as per ISO 10993 Standards)
10993 - 3 : Tests for
Genotoxicity, Carcinogenicity, Reproductive
Toxicity
10993 - 6 : Tests for
local Effects after Implantation
10993 - 10 : Tests for Irritation
and Sensitization
10993 - 11 : Tests for Systemic Toxicity
10993 - 16 : Toxicokinetic Study
Design for Degradation Products / Leachable