Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett. Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics. "Design is intelligence made visible." -- Alina Wheeler

1. How to understand
regulators to design
experiments in pharma
product development
Ajaz | Insights

6. DOE why?
Rational, rigorous, reproducible and repeatable
cause-and-effect relationships that serve as
evidence and warrant your claims
Critical quality attributes, critical process parameters,
speculations, stability (shelf-life), repeatability, reproducibility,
… bioavailability, bioequivalence
And Design Space, Comparability Protocol, Evolutionary Operation
(EVOP), Continual Improvement
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting
interactions, multivariate predictive capability, minimization, maximization, optimization, graphical
illustration for enhanced communication of complex topics

7. Design of Experiments:
In developing products
and their manufacturing
process
DOE is not Design Space
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8. Design Space(ICH Q8R2): Misconceptions
• DOE = Design Space
• Design Space is required
• Including of Design Space in development report will reduce
deficiencies
• Only critical parameters should be in a Design Space
• Edge-of-failure needed to define Design Space

9. Take an
integrated
design and
systems
approach
Ask the right questions to know the answers you want
Then design your experiments – not just jump to a
popular design
Consider real-world constraints; e.g., mixture designs
Remember garbage in = garbage out
DOE “Good Practices,” e.g., randomization,
replication,…. Assumptions, constraints
The approach you take to DOE says a lot about your
“development”

10. Pharmaceutical Quality System
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11. Design thinking
Inspiration, ideation, and implementation
Desirability
“voice of the customer,” human-centered design or empathy,
to fully understand the problems within the organization by
asking what people are “hearing and seeing and feeling and
thinking.”
Feasibility what is possible in the organization in terms of existing and
potential capacity, human resources, processes, and technology
Viability
how an initiative can be “hardwired into the organization” so it
has a higher likelihood of continuing long past the point of
implementation – over a product life cycle

12. Integrative
Thinking
• Salient variables are identified, the
causal map is built, action is
sequenced, and choices made
• P-centric design; P = profiteer, patient,
public-health, professionals &
practitioners
• Regulatory life-cycle system
• Mechanistic & statistical predictability
Roger Martin and Hilary Austen. The Art of Integrative Thinking.
Rotman Management Fall 1999

13. By Design is intention to do good
not just be and look good.
Do + Be + Look Good is
integrated development
Do good is to be self-authored,
self-assured, internally validated
Be good is to comply to what
others require
Looking good seeks external
validation