Suggestions for Streamlining and Optimizing Clinical End-Point Bioequivalence Studies for US Abbreviated New Drug Application Submissions

Clin Pharmacol Ther. 2019 Feb;105(2):310-312. doi: 10.1002/cpt.1252. Epub 2018 Nov 14.

Authors

Charles E DiLiberti¹, Charles Bon², Pina D'Angelo³, Keith Gallicano³, Diane Potvin⁴

Affiliations

¹ Montclair Bioequivalence Services, LLC, Montclair, New Jersey, USA.
² Biostudy Solutions, LLC, Wilmington, North Carolina, USA.
³ Novum Pharmaceutical Research Services, Pittsburgh, Pennsylvania, USA.
⁴ Excelsus Statistics Inc., Montreal, Quebec, Canada.

PMID: 30430559
DOI: 10.1002/cpt.1252

No abstract available

MeSH terms

Drug Approval / methods*
Endpoint Determination / standards*
Humans
Reference Standards
Reproducibility of Results
Research Design
Therapeutic Equivalency*
United States
United States Food and Drug Administration