ICH Q12 Examples – Pharmaceutical Product Lifecycle Management Examples – FDA Guidance
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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...
Minimum QbD, Enhanced QbD, and R&D QbD – How Are They Different?
I know what you are thinking. “We have no resources for implementing a full QbD. What is the minimum requirement to call our development process a QbD?” This article addresses that question. But it also provides a roadmap to enhance the “minimum QbD” over a period of time. Ildikó...
Pharmaceutical Quality by Design Book – Practical or Theoretical? [Interview]
A new book on Quality by Design was recently published. When I read such a book on QbD, I ask – “is it merely theoretical or actually practical?” As a scientist who deals with the reality of messy biologics and constraints of time and resources at the office, I...
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...
QbD – Doing More with Less with these 3 Tools [Mehtap Saydam]
What if we could predict the relationship of QTPP, CQA and CPP of our drug – with less clinical data? Mehtap Saydam, our QbD evangelist from Turkey describes that there is a way with the 3 tools – In Vitro Testing; Biopharmaceutical Classification Systems; and QbD Risk Assessment. “In...
Quality in Pharmaceutical Industry – Literature Review
Quality in the Pharmaceutical Industry – A Literature Review Here is a Literature Review on the topic of Quality in the Pharmaceutical Industry. It is not specific to Quality by Design (QbD) or (Process Analytical Technology) PAT. However the literature review does have a small section on both QbD...
Pedro Hernandez – A Tribute to QbD and PAT Evangelist
Our fellow QbD evangelist – passed away this month. He will be missed by many of us. My friend, Mehtap Saydam suggested we reflect on Pedro’s contribution as a community with Pedro’s family at this time. Pedro presenting at a conference Urn of Pedro with his family...
QbD Application in Pharmaceutical Development for Nano Formulation
“This method (in QbD) can improve pharmaceutical nano-developments by achieving shorter development time, lower cost, saving human resource efforts and more effective target-orientation.” Edina Pallagi, PhD, Rita Ambrus, Piroska Szabó-Révész, and Ildikó Csóka (University of Szeged) recently published, “Adaptation of the quality by design concept in early pharmaceutical development of...
QbD Publications and Literature
Are you applying Quality by Design in: Blending, Granulation, Milling, Compression, Packaging, Cell Culture, Chromatography, Filtration, Purification, Formulations, Lyophilization, Analytical Chemistry, CMC, Assay Development? Do you plan to publish a Quality by Design article and want to know which journals to submit to? Do you have a publication related...