QbD for Drug Device Combination Products – Part 2
This is the part 2 of the interview from Manfred on the drug device combination product. If you haven’t yet, please listen to the first part of QbD for Drug Device Combination Products. Today, we cover: Design Controls versus Quality by Design (QbD) – how is it different? When...
How To Apply QbD to Drug Device Combination Products
Today, we invite Dr. Manfred Maeder of Novartis to share how Quality-by-Design is applied in the development of medical devices and drug device combination products. Previously, Dr. Lana Shiu of FDA shared the ongoing regulatory changes in drug device combination products. I recommend you listen to her presentation as...
QbD for Dry Powder Inhalation Formulation (Combination Product)
Dr. Edina Pallagi is the QbD pioneer of Hungary. The University of Szeged team recently published, “New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach” For a complimentary PDF access, download the QbD case study by Sept. 5 The one-sentence takeaway is: By...