PT  - JOURNAL ARTICLE
AU  - Newcombe, Anthony R.
TI  - The Evolution of Quality by Design (QbD) for Biologics
AID  - 10.5731/pdajpst.2014.00989
DP  - 2014 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 320--322
VI  - 68
IP  - 4
4099  - http://journal.pda.org/content/68/4/320.short
4100  - http://journal.pda.org/content/68/4/320.full
SO  - PDA J Pharm Sci Technol2014 Jul 01; 68
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.