Design is to do good not just be and look good: Bad Design is Smoke, Good Design is a Mirror.
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The document discusses the importance of understanding regulators and applying design of experiments (DOE) in pharmaceutical product development to ensure rational and reproducible results. It emphasizes the distinction between DOE and design space, criticizes misconceptions surrounding design space, and highlights the need for an integrated approach that considers feasibility and viability in experiments. Additionally, it explores concepts like design thinking and integrative thinking to enhance problem-solving within organizations.
Design is to do good not just be and look good: Bad Design is Smoke, Good Design is a Mirror.
- 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 4/22/2021 Ajaz S Hussain Ph.D. 7
- 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 4/22/2021 Ajaz S Hussain Ph.D. 10
- 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