The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs ICH Q11 focuses ...

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance. The quality-by-design (QbD) initiative, which focuses on building ...

Amgen, Genentech, Abbott, Medlmmune, GSK, Lilly, and Pfizer will create examples of development programs that follow ICH quidelines for product registration. Conformia has brought together seven ...

The ICH and FDA guidance documents on Pharmaceutical cGMPs stress the importance of management's responsibility to meet customer needs by encompassing quality improvement through quality by design ...