Understanding pharmaceutical quality by design
Contributor(s):: Yu, Lawrence X, Amidon, Gregory Khan, Mansoor A Hoag, Stephen W, Polli, James, Raju, G K, Woodcock, Janet
This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and...