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

Autor: DiLiberti CE; Montclair Bioequivalence Services, LLC, Montclair, New Jersey, USA., Bon C; Biostudy Solutions, LLC, Wilmington, North Carolina, USA., D'Angelo P; Novum Pharmaceutical Research Services, Pittsburgh, Pennsylvania, USA., Gallicano K; Novum Pharmaceutical Research Services, Pittsburgh, Pennsylvania, USA., Potvin D; Excelsus Statistics Inc., Montreal, Quebec, Canada.
Jazyk: angličtina
Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2019 Feb; Vol. 105 (2), pp. 310-312. Date of Electronic Publication: 2018 Nov 14.
DOI: 10.1002/cpt.1252
Databáze: MEDLINE
Externí odkaz: