Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap

Sven Stegemann*, Liz Sheehan, Alessandra Rossi, Andrew Barrett, Amrit Paudel, Abina Crean, Fabrice Ruiz, Massimo Bresciani, Fang Liu, Zakia Shariff, Margarete Shine, Christel Schmelzer, Anne Marie Pense-Lheritier

*Korrespondierende/r Autor/-in für diese Arbeit

Publikation: Beitrag in einer FachzeitschriftReview eines Fachbereichs (Review article)Begutachtung

Abstract

The increasing awareness of acceptability and usability of pharmaceutical drug products by the patient as a key quality requirement continues to drive need for integrating patient centric drug product design into the pharmaceutical development process. The complex matrix of multiple drug product related decisions during the early drug development process often limits patient-centric drug product (PCDP) design options in the final commercial drug product development phase. To integrate the specific needs and perspectives of patients into drug development and product design process, a rational approach integrated into the complex development matrix is required from the start and weighs product development decision options accordingly. The aim of this work was to develop a roadmap for PCDP design in a multidisciplinary approach that leads to better usability, adherence and acceptance of the drug by patients via early integration into the development matrix. The proposed rational approach is based upon regulatory requirements and lessons learned from pediatric and geriatric drug development.

Originalspracheenglisch
Seiten (von - bis)81-88
Seitenumfang8
FachzeitschriftEuropean Journal of Pharmaceutics and Biopharmaceutics
Jahrgang177
DOIs
PublikationsstatusVeröffentlicht - Aug. 2022

ASJC Scopus subject areas

  • Biotechnology
  • Pharmazeutische Wissenschaften

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