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

Clin Pharmacol Ther. 2018 Mar;103(3):378-383. doi: 10.1002/cpt.978. Epub 2018 Jan 13.

Abstract

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.

MeSH terms

  • Clinical Trials as Topic
  • Crowdsourcing
  • Drug Therapy / standards*
  • Drug Therapy / trends*
  • Humans
  • Pharmaceutical Preparations / administration & dosage*
  • Pharmacology, Clinical / standards*
  • Pharmacology, Clinical / trends*
  • Research Design
  • Therapies, Investigational / standards*
  • Therapies, Investigational / trends*
  • Translational Research, Biomedical

Substances

  • Pharmaceutical Preparations