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

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

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.

Original languageEnglish
Pages (from-to)81-88
Number of pages8
JournalEuropean Journal of Pharmaceutics and Biopharmaceutics
Volume177
DOIs
Publication statusPublished - Aug 2022

Keywords

  • Acceptability
  • Compliance/adherence
  • Drug development
  • Drug product design
  • Effectiveness
  • Medication errors
  • Patient centric
  • Target product profile

ASJC Scopus subject areas

  • Biotechnology
  • Pharmaceutical Science

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