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Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions

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Authors and Affiliations

  1. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, 5600 Fishers Lane, Rockville, Maryland, 20857

    Lawrence X. Yu, Hong Zhao, Mehul U. Mehta, Dale P. Conner, Vinod P. Shah, Lawrence J. Lesko, Mei-Ling Chen & Ajaz S. Hussain

  2. Department of Pharmaceutics, University of Michigan, College of Pharmacy, Ann Arbor, Michigan, 48109-1065

    Gordon L. Amidon

  3. Department of Pharmaceutical Sciences, University of Maryland, School of Pharmacy, Baltimore, Maryland, 21201

    James E. Polli

  4. Department of Pharmaceutical Sciences, University of Southern California, School of Pharmacy, Los Angeles, California, 90089-9121

    Vincent H. L. Lee

Authors
  1. Lawrence X. Yu
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  2. Gordon L. Amidon
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  3. James E. Polli
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  4. Hong Zhao
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  6. Dale P. Conner
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  8. Lawrence J. Lesko
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  11. Ajaz S. Hussain
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Correspondence to Lawrence X. Yu.

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Yu, L.X., Amidon, G.L., Polli, J.E. et al. Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions. Pharm Res 19, 921–925 (2002). https://doi.org/10.1023/A:1016473601633

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