| Autor: |
Patrick R. Connelly, Brian Patrick Quinn, Steve Johnston, Anuj K. Kuldipkumar, Hongren Wang, Phillip W. Snyder, Patricia Hurter, Andrey Peresypkin, Philip Bransford, Jeff Katstra, Setu Roday, Praveen Mudunuri, Majed Fawaz, Bill Rowe, Tapan Sanghvi |
| Rok vydání: |
2015 |
| Předmět: |
|
| Zdroj: |
Pharmaceutical Sciences Encyclopedia |
| Popis: |
This chapter demonstrates that the personnel involved in translational drug development (TDD) are integrated into each stage of discovery and development, serving as regular members of working groups, projects teams, and major steering committees. The early development of amorphous dispersions is carried out using certain aspects of telaprevir as an example. TDD charges the pharmaceutical development division with understanding a broad range of physicochemical properties as early as possible in a compound's development. In developing a suspension formulation of an amorphous dispersion, a mathematical, biopharmaceutical model that predicts absorption is created to ensure that a preclinical study will not result in inadequate exposure in vivo. An advance in the pharmaceutical industry would move us away from much of the current a posteriori trial-and-error empiricism and into a level of rigor one can expect in other technically intensive sectors of the society. Keywords: amorphous dispersions; biopharmaceutical model; physiochemical properties; telaprevir; translational drug development (TDD); trial-and-error empiricism |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
