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Drug Regulatory Affairs

by Vyawahare, Ns

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Description

Regulatory Affair and its Importance - Drug Discover and Development - Regulatory Strategy - Investigational New Drug Application IND - New Drug Application NDA - Abbreviated New Drug Application ANDA - Drug Master File DMF - Orphan Drug - Biological Licensing Application BLA - Registrationa of Drug Products in Overseas Markets Pharmaceutical export - Regulatory Authorities and Agencies - Overview of Drug and Cosmetic Act - Regulatory Guidelines - Useful Information

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Product Details

  • Nirali Prakashan Brand
  • Jul 4, 2005 Pub Date:
  • 9380064683 ISBN-10:
  • 9789380064680 ISBN-13:
  • English Language
  • 9.69 in * 0.68 in * 7.44 in Dimensions:
  • 1 lb Weight: