Risk to Quality and Structured Biopharmaceutics Assessment will identify biopharmaceutics risks to drug product quality and highlight development of a Structured Biopharmaceutics Assessment. This presentation will aim to achieve the following objectives, (1) describe how knowledge aided assessment can facilitate risk assessment, (2) outline the biopharmaceutics risk assessment focusing on clinical performance, and (3) provide the advantages of enhanced risk communication toward PCQS
Upon completion, participant will be able to understand the structured knowledge to facilitate biopharmaceutics risk assessment.
Upon completion, participant will be able to identify scientifically-sound biopharmaceutics risk assessment criteria focusing on clinical performance
Upon completion, participant will be able to define PCQS and its role in enhanced risk communication.