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

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Medicine and Dentistry

Pharmacology, Toxicology and Pharmaceutical Science

Engineering

Biochemistry, Genetics and Molecular Biology