Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use

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...

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Detalles Bibliográficos
Autores principales: Nayak, Satyaprakash, Sander, Oliver, Al‐Huniti, Nidal, de Alwis, Dinesh, Chain, Anne, Chenel, Marylore, Sunkaraneni, Soujanya, Agrawal, Shruti, Gupta, Neeraj, Visser, Sandra A.G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Perspectives
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838712/
https://www.ncbi.nlm.nih.gov/pubmed/29330855
http://dx.doi.org/10.1002/cpt.978
Descripción
Sumario: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.

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