Studies in which a drug is tested on animals and in other non-human test systems. Safety information from such studies are used to support an investigational new drug application. The main goals of pre-clinical studies (also named animal toxicology and nonclinical studies) are to determine a product's ultimate safety profile. For instance, drugs may undergo pharmacodynamics (PD), pharmacokinetics (PK), ADME, and toxicity testing through animal testing.
Our associate animal toxicological study centers are providing preclinical studies services to fulfill requirements of registration dossier.
Toxicity Studies :
- Acute Toxicity
- Subchronic Toxicity
- Chronic Toxicity
- Reproduction / Teratology Studies etc.
- Median lethal dose (LD 50)
Reports prepared :
More than 100 reports are prepared overall for CIS Countries, Russia, Latin America, African countries, Middle East countries etc.
Format And Guideline :
As per country specific guideline.