FDA: Q8(R1) Pharmaceutical Development Revision 1

This guidance is a revision of the ICH guidance Q8 Pharmaceutical Development (Q8 parent guidance) that published in May 2006. The Q8 parent guidance is revised to add an annex, which provides further clarification of the key concepts outlined in the May 2006 guidance and describes the principles of quality by design (QbD). This Q8(R1) document includes the Q8 parent guidance and the annex.