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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
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Guidelines are the consensus document
accepted by a regulatory body
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REGULATORY AGENCIES
■ ICH ■ OECD■ FDA ■ WHO
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NEED OF GUIDELINES
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■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
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■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
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■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
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■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
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Thank You