HT25
Background
Personalized pharmaceutical dosage forms offer a promising approach to meet individual patients’ needs and to optimize treatment efficacy and safety. Critical Quality Attributes (CQAs) are the important physical and chemical properties of a pharmaceutical product that must be controlled to ensure its quality, safety, and efficacy. However, there is limited experience regarding CQAs that may be crucial for personalized pharmaceutical dosage forms, and existing regulatory guidance remains incomplete.
Aim
The aim of the proposed project is first to explore pharmaceutical dosage forms used in personalized medicine and to identify the CQAs essential for their optimal performance by a systematic literature review. This is followed by an analysis of the current regulatory framework, including the European Pharmacopoeia and guidelines issued by the Regulatory Authorities such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), to highlight areas requiring further development.
Expected outcome
This project aims to identify Critical Quality Attributes (CQAs) essential for personalized pharmaceutical dosage forms while also highlighting gaps in the current regulatory framework used by Regulatory Authorities. Additionally, it will explore regulatory opportunities for decentralized manufacturing (if time permits).
Note
It is expected that the project report is written in English.
Farmaceutisk vetenskap
Galenisk farmaci
Litteraturstudie
RegSmart
Uppsala
Ann-Sofie Persson (UU), Eva Ragnarsson och Agneta Larhed (RegSmart)
ann-sofie.persson@uu.se
Institutionen för farmaceutisk biovetenskap
Apotekarprogrammet
Fördjupningsprojekt i galenisk farmaci med inriktning mot farmaceutisk teknologi 30 hp - 3FB033
30hp
1