QbD Implementation on Medical Devices (Drug Eluting Stents)
Does Quality by Design apply to Medical Devices? We’ve seen it coming down to combination products. Now QbD implementation on Medical Devices. My colleagues working in the medical devices claims Design Controls is comparable to QbD. Design controls is a FDA guidance to product development activities. However, it is...
How to Choose Which Design Space Studies to Work On – Why QbD Risk Assessment is Not Just a Risk Assessment
If you ask an average pharmaceutical scientist, “What is QbD?” she or he will mostly likely answer: DOE (Design of Experiments). As scientists, we are attracted to design space studies (including myself) because it is an extension of our daily work. However the bigger question is – “Which process...
QbD Design Space for Analytical Assay — Screening DOE [Tutorial]
I’m excited to share a Case Study on QbD Design Space for Analytical Assay — Screening DOE. Dr. HS Kim from Green Cross kindly shared his slides titled: “QbD using Design of Experiments Application for Analytical Assay.” The data of the experiment comes from Experimental Design in Biotechnology (Statistics: A Series...
Why Not Use Design of Experiments for QbD?
Confession Today, I share an embarrassing story… I did not truly appreciate DOE. When I was teaching Six Sigma topics at Stanford University and Keio University, I only scratched the surface level. Main reason was that most project sponsors could not share their proprietary or confidential details (process parameters), hiding real numbers...
JMP Setup Guide for DOE – in 1 Minute
Now that we’ve covered: How to conduct QbD Risk Assessment in a smart way, I’d like to move onto the next step – QbD Design Space in a smart way. Before we get into details, let’s set up our main tool –JMP– for success. Surprisingly, many JMP users aren’t aware...
Design Space in QbD — Definitions
If you are new to QbD, here are the basic definitions of “Design Space” in QbD. If you have to explain the terminologies to your colleagues, you can refer them to this page as a resource. I’m building a resource page (Start Here) for QbD newcomers. ICH Q8 (R2)...
QbD Framework – in 2 Minutes (for Scientists)
When I began my QbD journey, I was confused by the jargons that FDA or ICH used (or created) in their guidelines. After some time I understood it. But now I had to explain it to those who are new to Quality by Design. They were unimpressed due to...
Sample Size Question – How to Answer it as a R&D Scientist
How to answer the question–“What Sample Size do we need?”– as a R&D scientist. Before running an experiment, you or someone from Quality will inevitably ask the sample size question. You could regurgitate this or use this calculator. However it’s still confusing. Here’s how to answer it in...
How to Approach Design of Experiments in a Practical Way
A Scientific Method for Experimentation How to Approach Design of Experiments in a Practical Way. [leadplayer_vid id=”52594F7A0148B”] Lots more to come. Subscribe. SLIDE: A Scientific Method Model for Experimentation So here is the scientific method model for experimentation. It’s a little bit messy graph, but I hope you...
History of Design of Experiments
A Brief History of Design of Experiments – DOE. [leadplayer_vid id=”52594A4A370DB”] Please Subscribe to receive further Tutorials. There’s lots more to come. SLIDE: The Scientific Method and the History of Experimentation (Aristotle, OFAT, Fisher, Box and Taguchi) Let’s talk a little about the history of DOE. We like...