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PDA Biosimilars Workshop Report (September 27—28, 2018)—Getting It Right the First Time for Biosimilar Marketing Applications

Stephan Krause, Emanuela Lacana, Joel Welch, Marjorie Shapiro, Christopher Downey, Jee Chung, Qing Zhou, Martijn Van Der Plas, Chantal Depatie, Bev Ingram, Catherine Srebalus-Barnes, Alla Polozova, Barbara Rellahan, Daeseok Choi, Richard Burdick, Thomas Stangler and Emily Shacter
PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 401-416; DOI: https://doi.org/10.5731/pdajpst.2019.010215

References

  1. 1.
  2. 2.
    FDA Guidance for Industry: Data Integrity and Compliance with Drug CGMP, December 2018.
  3. 3.
    US Code of Federal Regulations, Title 21, Part 11.
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PDA Biosimilars Workshop Report (September 27—28, 2018)—Getting It Right the First Time for Biosimilar Marketing Applications
Stephan Krause, Emanuela Lacana, Joel Welch, Marjorie Shapiro, Christopher Downey, Jee Chung, Qing Zhou, Martijn Van Der Plas, Chantal Depatie, Bev Ingram, Catherine Srebalus-Barnes, Alla Polozova, Barbara Rellahan, Daeseok Choi, Richard Burdick, Thomas Stangler, Emily Shacter
PDA Journal of Pharmaceutical Science and Technology Jul 2019, 73 (4) 401-416; DOI: 10.5731/pdajpst.2019.010215
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