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Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use
Author(s) -
Nayak Satyaprakash,
Sander Oliver,
AlHuniti Nidal,
Alwis Dinesh,
Chain Anne,
Chenel Marylore,
Sunkaraneni Soujanya,
Agrawal Shruti,
Gupta Neeraj,
Visser Sandra A.G.
Publication year - 2018
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.978
Subject(s) - medicine , clinical trial , pharmacology , clinical pharmacology , translational medicine , drug development , stakeholder engagement , stakeholder , selection (genetic algorithm) , drug , intensive care medicine , medical physics , computer science , political science , pathology , public relations , artificial intelligence , law
Quantitative pharmacology (QP) applications in translational medicine, drug‐development, and therapeutic use were crowd‐sourced by the ASCPT Impact and Influence initiative. Highlighted QP case studies demonstrated faster access to innovative therapies for patients through 1) rational dose selection for pivotal trials; 2) reduced trial‐burden for vulnerable populations; or 3) simplified posology. Critical success factors were proactive stakeholder engagement, alignment on the value of model‐informed approaches, and utilizing foundational clinical pharmacology understanding of the therapy.