X hits on this document

Powerpoint document

Quality by Design: Next Steps to Realize Opportunities? - page 33 / 37

132 views

0 shares

0 downloads

0 comments

33 / 37

What steps (is) should FDA (taking) take to realize the benefits of QbD?

While the ICH process on Pharmaceutical Development is ongoing

Focus on SUPAC-C concept

Work with/within the draft Comparability Protocol Guidance

Is this format too restrictive?

In addition to Comparability Protocol concept develop additional guidance on SUPAC-C

Appendix to Comparability Protocol?

Planned revisions of current SUPAC guidance?

Independent SUPAC-C guidance?

Document info
Document views132
Page views132
Page last viewedTue Jan 24 07:29:59 UTC 2017
Pages37
Paragraphs609
Words2099

Comments