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NOVA’s approach to Model Informed Drug Development
Jules Henri Poincaré (French mathematician, 1854-1912) Science is facts; just as houses are made of stone, so is science made of facts; but a pile of stones is not a house,…
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Part 9. Conclusions
Baruch Spinoza wrote “demonstrations are the eyes of the mind"[1]. By demonstration he meant something like “rigorous reasoning”. If we add “validated”,…
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Part 8. Expected consequences on R&D and future of MIDD
TL; DR Currently, MIDD ideally remains centred on in vivo clinical trials, which are the ultimate proof. In the future, however, it is plausible that in vivo clinical trials will move to the role of…
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Part 7. What can NOVA’s approach be used for?
TL; DR NOVA's approach allows for the model to be progressively updated with new information collected in response to the current question and help to answer a consecutive one.…
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Part 6. Are M&S outputs real?
TL; DR Once the model is suitably validated, it will predict the therapy’s efficacy. This prediction is based on knowledge that science assumes real, and applied to virtual data,…
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Part 5. Examples of Effect Model applications
TL; DR The EM serves to run in silico clinical trials cheaper and faster than in vivo clinical trials. EM can be applied from discovery (target selection) to market access (translating trial…
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Part 4. Responders - the M&S perspective
TL; DR One of the most promising contributions of M&S to R&D is the identification of responders. This aspect approaches the field of personalized medicine.…
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Part 3. NOVA’s Modeling and Simulation approach
TL; DR Clinical outcome is an ultimate focus of the M&S process. Six-steps process consists of: Problem formulation (project plan), Systemic knowledge review (knowledge model), Computational model,…
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Part 2. NOVA’s approach reconciles knowledge with data to predict clinical outcomes
TL; DR The M&S approach in MIDD should be designed and operated for the patient's health (in the form of clinical outcome). The M&S is the mix of the top-down problem solving approach and the…
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Part 1. Introductory remarks
TL; DR Models are just simplified representation of a real world with some constraints, which quickly become obsolete and need to be updated from time to time.…