PRECLINICAL/NON-CLINICAL/TOXICOLOGICAL STUDIES

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

DocentPharma can:

• Toxicity Studies:
  • Acute Toxicity
  • Subchronic Toxicity
  • Chronic Toxicity
  • Carcinogenicity
  • Mutagenicity
  • 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: docent@docentpharma.com