Importance of guidelines in regulatory toxicity testing
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The document emphasizes the importance of regulatory guidelines in toxicity studies to ensure the safety, efficacy, and quality of medicines while minimizing animal testing. It highlights the role of major regulatory agencies like ICH, OECD, FDA, and WHO in harmonizing technical requirements and streamlining clinical trials. Furthermore, these guidelines support economic growth and improve international collaboration in chemical assessment and biocide regulation.
Importance of guidelines in regulatory toxicity testing
- 1. Importance of Guidelines in Regulatory Toxicity studies Chander K Negi M.S Pharm, Regulatory Toxicology National Institute of Pharmaceutical Education and Research, S.A.S. Nagar, Punjab-160062 chandernegi09@gmail.com
- 2. Guidelines are the consensus document accepted by a regulatory body
- 3. REGULATORY AGENCIES ■ ICH ■ OECD ■ FDA ■ WHO
- 5. ■ Prevent duplication of clinical trials in humans ■ Ensure SAFETY, EFFICACY and QUALITY of medicines ■ Minimize the use of animal testing without compromising safety and effectiveness
- 6. ■ Provides the definite parameters of evaluation ■ Provides a roadmap to prepare a study protocol ■ Increase international harmonization of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost effective manner
- 7. ■ Supports economic growth, raise living standards, maintain financial stability and contribute to growth in world trade ■ Regulation of biocides – OECD biocide programme aims to attain a harmonized approach in the regulation of biocides
- 8. ■ Assessment of chemicals- harmonized activities concerning new chemical to reduce work of government and cost of industry ■ Chemical testing guidelines- most relevant internationally agreed method used by government, industry and independent laboratories to assess safety of chemical products
- 9. Thank You