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- Published online August 6, 2019.
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- previous version (April 19, 2019 - 08:56).
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© PDA, Inc. 2019
Author Information
- Stephan Krause1,*,
- Emanuela Lacana2,
- Joel Welch2,
- Marjorie Shapiro2,
- Christopher Downey2,
- Jee Chung2,
- Qing Zhou2,
- Martijn Van Der Plas3,
- Chantal Depatie4,
- Bev Ingram5,
- Catherine Srebalus-Barnes6,
- Alla Polozova7,
- Barbara Rellahan8,
- Daeseok Choi9,
- Richard Burdick10,
- Thomas Stangler11 and
- Emily Shacter12
- 1AstraZeneca Biologics, 1 Medimmune Way, Gaithersburg, MD 20878;
- 2CDER, U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, Silver Spring, MD 20993;
- 3Medicines Evaluation Board (MEB), Graadt van Roggenweg 500, 3531 AH Utrecht, The Netherlands;
- 4Health Canada, 100 Eglantine Driveway, Ottawa, ON K1A 0K9, Canada;
- 5Pfizer Inc., 1 Burtt Road, Andover, MA 01810;
- 6Pfizer Inc., 275 North Field Drive, Lake Forest, IL 60045;
- 7Amgen Inc., 360 Binney Street, Cambridge, MA 02142;
- 8Amgen, Inc., 601 13th Street, NW, Suite 1100 North, Washington, DC 20005;
- 9CELLTRION Inc., 19, Academy-ro 51, Yeonsu-gu, Incheon 406-840, Republic of Korea;
- 10Burdick Statistical Consulting, LLC, 7783 Renegade Hill Drive, Colorado Springs, CO 80923;
- 11Novartis, Biochemiestraße 10, 6336 Langkampfen, Austria; and
- 12ThinkFDA, LLC, 710 Erie Ave, Takoma Park, MD 20912
- ↵* Corresponding Author: AstraZeneca Biologics, 1 Medimmune Way, Gaithersburg, MD 20878; Phone: 301-398-2108; E-mail: Stephan.Krause{at}astrazeneca.com