Studies in which a drug is tested on animals and in other non-human test systems. The main goals of pre-clinical studies (also named animal toxicology and non-clinical 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.
DocentPharma advantage for Toxicological Studies:
- Coordination for toxicological studies (on behalf of manufacture)
- Low cost due to our long-term alliance with CROs Providing complete protocol and report (as per country specific guideline)
- Handling all pre-registration and post-registration
- Toxicity Studies:
- Acute Toxicity
- Subchronic Toxicity
- Chronic Toxicity
- Reproduction/Teratology Studies etc.
- Median lethal dose (LD 50)
- Carry out pre-study audits of the CRO,
- Provide advice on and review toxstudy designs,
- Review & helping in preparation of Protocol for various countries as per respective regulatory authority’s guidance.
- Monitor studies to ensure Good Laboratory Practise (GLP) compliance,
- Review of final reports.
Format & Guideline: - As per country specific guideline.
For DocentPharma preclinical/non-clinical/toxicological services or information, please write email to us: firstname.lastname@example.org