de Vlieger, Jon S. B.
Crommelin, Daan J. A.
Tyner, Katherine
Drummond, Daryl C.
Jiang, Wenlei
McNeil, Scott E.
Neervannan, Sesha
Crist, Rachael M.
Shah, Vinod P.
Article History
Received: 12 February 2019
Accepted: 5 April 2019
First Online: 17 April 2019
Compliance with Ethical Standards
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: Work of authors SEM and RC has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, under Contract No. HHSN261200800001E. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.The opinions expressed in this article are those of the authors and not of any regulatory, industry, or medical organization they may be affiliated with, including the EMA and the FDA. JdV, DC, SN, SEM, VS are members of the Non-biological complex drugs Working Group hosted at Foundation Lygature, the Netherlands: ExternalRef removed