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Activity Number: 85
Type: Contributed
Date/Time: Sunday, August 9, 2015 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract #316255 View Presentation
Title: Model-Based Meta-Analysis of Clinical Dose Response for Biological Products
Author(s): Joseph Wu* and Anindita Banerjee and Bo Jin and Sandeep Menon and Steven Martin
Companies: Pfizer Inc. and Pfizer Inc. and Pfizer Inc. and Pfizer Inc. and Pfizer Inc.
Keywords: Dose response ; Emax ; Meta-analysis ; Biological products
Abstract:

Dose-finding clinical trials play an indispensable role in learning the dose response and identifying the right dose. One of the main challenges is to determine the dose response model. There is a strong support to adopt a model-based approach to dose-finding based on a number of meta-analytical studies in the literature. Specifically, Thomas, Sweeney, and Somayaji (2014) reported results of a meta-analysis for a large set of small-molecule drugs across different therapeutic areas, showing that the hyperbolic Emax model as an appropriate model. There is an increasing interest if the hyperbolic Emax model can describe the dose response relationship for DNA-recombinant biological products which may have more complex PD/PK mechanisms. We conducted a literature search across a range of disease areas and sampled a broad set of published dose-ranging trials on biological products. We meta-analyzed the data and assessed if the hyperbolic Emax model can sufficiently describe the dose response summary data. The implications for supporting model-based development and designing future dose-finding for biologics will be discussed based on the results of this meta-analysis.


Authors who are presenting talks have a * after their name.

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