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Author contribution
J Zhang: project administration, investigation, methodology, formal analysis, writing. A Dasgupta: investigation. R Ayala: investigation. C Bonapace: investigation, supervision. S Kassim: project administration, supervision.PJ Faustino: project administration, supervision.
Disclaimer
This publication reflects the views of the authors and should not be construed to represent FDA's views or policies.
Financial disclosure
The authors have no financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Competing interests disclosure
The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Writing disclosure
No writing assistance was utilized in the production of this manuscript.
Acknowledgments
The authors thank W Li (Novartis), S Lowes (Q Squared Solutions), E Woolf (Merck), N Weng (Janssen, now GSK), W Jian (Janssen), FF Vazvaei-Smith (Merck) and L Li (Office of Bioequivalence, Office of Generic Drugs, FDA/CDER) for valuable discussions.