Pharmaceutical drug development separation science role

The Role of Separation Science in Pharmaceutical Drug Development... [Pg.431]

THE ROLE OF SEPARATION SCIENCE IN PHARMACEUTICAL DRUG DEVELOPMENT... [Pg.432]

In pharmaceutical laboratories, the use and importance of separation sciences extends throughout almost all aspects of the development process [28]. Separation methodology is used in the very early stages of discovery research, where numerous biologically active chemical entities must be separated to provide information on relative purities and impurities levels. In the pre-clinical and clinical phases of the drug development process, separation methods play a pivotal role in fully characterising chemical entities prior to use in human clinical studies. Tliroughout the process, batches of API are prepared... [Pg.32]