Ensuring consistent clinical performance.
By Kenneth Norris, Pfizer Inc.; Dorys Argelia Diaz, Pfizer Inc.; Mohan Ganapathy, Merck & Co. Inc.; Lynn Gold, Camargo Pharmaceutical Services; and Ling Zhang, Pfizer Inc.
What progress has been made on establishing clinically relevant specification implementation, and what are the opportunities to align on the application of scientific approaches? Asking end product testing to adequately serve as a quality control and as a clinically relevant surrogate has always been a challenge. Because the dissolution test has been identified as a potential basis for granting biowaivers, it is a logical test to establish clinically relevant acceptance criteria.