importance of guidelines in regulatory toxicity testing
TRANSCRIPT
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
Guidelines are the consensus document
accepted by a regulatory body
REGULATORY AGENCIES
■ ICH ■ OECD■ FDA ■ WHO
NEED OF GUIDELINES
■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
■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
■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
■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
Thank You