|
Activity Number:
|
77
- Contributed Poster Presentations: Biopharmaceutical Section
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Monday, August 3, 2020 : 10:00 AM to 2:00 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
|
Abstract #309735
|
|
|
Title:
|
Bioequivalence Study Design for Multiplicity
|
|
Author(s):
|
Michelle Quinlan* and Ekkehard Glimm and Bharani Bharani-Dharan
|
|
Companies:
|
Novartis Oncology and Novartis and Novartis Oncology
|
|
Keywords:
|
bioequivalence;
multiplicity
|
|
Abstract:
|
Bioequivalence (BE) is “the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study (FDA)”. In BE studies there can be two or more tests versus one reference to show comparability among formulations. E.g., two new formulations developed for future use compared to the reference formulation. This scenario warrants adjustment for multiplicity to ensure adequate control of overall type I error, however no HA guidance exists for multiplicity in BE studies. To address this problem, multiple designs with various testing strategies were explored. An innovative design that facilitated the development of a three arm BE study with multiplicity adjustment and adequate power for a ‘win’ based on at least one formulation meeting BE was selected. Key stakeholders were convinced on the need for an innovative study design with adequate power, which will facilitate a transformative solution to deliver the two new options for patients.
|
Authors who are presenting talks have a * after their name.
