Unit-1 New drug discovery and drug development PPT.ppt

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New drug discovery and drug development New drug discovery and drug development

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Unit-1
New Drug Discovery and development
Subject Code: BP804TT
SEMESTER: VIII
Subject Name: Pharmaceutical Regulatory science
By: Dr. Yogi Pandya (M.Pharm, Ph.D. )

Unit-1 New drug discovery and drug development PPT.ppt

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1. Introduction During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies. 2. Drug development team 3. Investigational new drug application (INDA) 4. Format and content of IND 5. Preclinical testing 6. The development process IND application and safety 7. Clinical research 8. New drug application 9. Abbreviated new drug application 10. Changes to an approved NDA or ANDA 11. Difference between NDA and ANDA

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Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to introduce requirements for countries to get permission for: Importing Manufacturing new drugs Conducting Clinical Trials. Application for permission Clinical Trial Studies in specific population Post marketing surveillance Special studies: BA/BE studies

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