RT Journal Article SR Electronic T1 The Evolution of Quality by Design (QbD) for Biologics JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 320 OP 322 DO 10.5731/pdajpst.2014.00989 VO 68 IS 4 A1 Anthony R. Newcombe YR 2014 UL http://journal.pda.org/content/68/4/320.abstract AB LAY ABSTRACT: In recent years, regulators have recognized the need for more controls in drug manufacturing processes. Quality by design is a science- and risk-based approach to drug product development and several pilot programs are ongoing to evaluate enhanced drug development strategies. This article provides a commentary on a recent regulatory publication on the subject of design space verification.