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Critical Quality Attributes in personalized pharmaceutical dosage forms: evaluation and regulatory perspectives

Terrmin

HT25

Beskrivning

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.

Huvudområde

Farmaceutisk vetenskap

Ämne

Galenisk farmaci

Typ

Litteraturstudie

Företag

RegSmart

Ort/Plats

Uppsala

Handledarens namn

Ann-Sofie Persson (UU), Eva Ragnarsson och Agneta Larhed (RegSmart)

Handledarens e-post

ann-sofie.persson@uu.se

Institution

Institutionen för farmaceutisk biovetenskap

Program

Apotekarprogrammet

Kurs

Fördjupningsprojekt i galenisk farmaci med inriktning mot farmaceutisk teknologi 30 hp - 3FB033

Omfattning/hp

30hp

Hur många studenter kan antagas för detta projekt?

1

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