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An illustration of the different barriers that must be overcome to gain the approval of a new drug product through either New Drug Application (NDA) or.

Published byShavonne Gaines Modified over 6 years ago

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Presentation on theme: "An illustration of the different barriers that must be overcome to gain the approval of a new drug product through either New Drug Application (NDA) or."— Presentation transcript:

1 An illustration of the different barriers that must be overcome to gain the approval of a new drug product through either New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) approval processes. BE = bioequivalence, PE = pharmaceutical equivalence. Source: Biopharmaceutical Aspects of the Active Pharmaceutical Ingredient and Pharmaceutical Equivalence, Applied Biopharmaceutics & Pharmacokinetics, 7e Citation: Shargel L, Yu AC. Applied Biopharmaceutics & Pharmacokinetics, 7e; 2016 Available at: Accessed: October 24, 2017 Copyright © 2017 McGraw-Hill Education. All rights reserved

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