Advances in Medicine Technologies

Recommended Prerequisites

Knowledge in Health Sciences and Pharmaceutical Technology. Knowledge of English language.

Teaching Methods

Each topic is addressed in the form of lectures by experts from each area.

Learning Outcomes

Provide students with knowledge of emerging areas in drug technologies, including recent approaches to pharmaceutical and analytical development, new manufacturing processes and dosage forms. Make known the application of process analytical technologies strategies in the context of the pharmaceutical industry and its relevance in real-time quality control.

Work Placement(s)

No

Syllabus

Quality by design approach to drug development;

Safety by design approach to drug development;

Process analytical technologies;

Continuous manufacturing;

Non-standard manufacturing processes (e.g. hot melt extrusion, 3D printing);

Non-standard dosage forms (eg microneedles, printlets).

Medicine and society: regulatory and economic framework.

Head Lecturer(s)

Carla Sofia Pinheiro Vitorino

Assessment Methods

Assessment
Project: 100.0%

Bibliography

Q8-Q14 ICH guidelines: https://www.ich.org/page/quality-guidelines

FDA Guidance document - Quality Considerations for Continuous Manufacturing: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-considerations-continuous-manufacturing

FDA Guidance for Industry: PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, 2004: https://www.fda.gov/media/71012/download

Nagy, Z. K., A. E. Hagrasy and J. Litster (2020). Continuous Pharmaceutical Processing, Springer International Publishing.

Schlindwein, W. S. and M. Gibson (2018). Pharmaceutical Quality by Design: A Practical Approach, Wiley

Aulton M.E and Taylor K.M.G. (Editors), Aulton’s Pharmaceutics: The Design and Manufacture of Medicines,

6th Ed. Elsevier. 2021, ISBN: 9780702081545.

Outro material disponibilizado nas aulas./Other material provided in the classes.