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Drug Product Development
Last Updated: 2026-02-05 16:06:46
Abstract
This course offers a training to understand the context (big picture), risks and opportunities of Drug Product Development and its interfaces.Experienced professionals from industry present and discuss development concepts and how development has to cooperate with surrounding functions to bring innovative and high quality products as fast as possible to patients.
Objective
- Students can explain fundamentals of GMP requirements (including qualification and validation) to be applied during drug product development activities. - Students are familiar with the general principles of drug product development for main dosage forms and can explain potential critical parameters enabling the development of high quality products (solid dosage forms, liquid/sterile/aseptically manufactured products; primary and secondary packed,….) - Students can describe a freeze drying process, how formulation development of lyophilizates works, how to develop a freeze drying process, how process controls are to be implemented and data are to be interpreted. Modules of freeze dryers are well known. - Students can describe technical enablers for optimized drug product development/manufacturing processes are knowledgeable about the variety of drug delivering systems and are able to set up a stability program to define shelf life for a new product. - Students can explain how important good definition and management of interfaces are to be agil, efficient, save costs and shorten time lines to supply products as fast as possible to patients (markets). - Students do understand the big picture what is important to bring drug product to patients and what role drug product development plays.
Content
Main focus is on sterile -liquids and lyophilized products-, solid dosage forms, as well as on packaging and stability. - Exposure to GMP fundamentals - Working in groups on specific technical items to educate each other - Active work on case studies/exercises/items during lectures and as pre-work for lectures - Development of a drug product and its manufacturing process, general principals. Critical parameters to be considered for high quality products - Development areas and their surrounding partners / Management of Interfaces/Behaviors as success factors
Resources
Lecture Notes
Handouts are available at beginning of each lecture.
Literature
- Klüglich M. Arzneimittelentwicklung , Editio Cantor Verlag, Aulendorf, 2018 - Eckstein N. Arzneimittel-Entwicklung und Zulassung, 2. Auflage, Deutscher Apotheker Verlag Stuttgart 2018 - Voigt R. Pharmazeutische Technologie, 10. Auflage, Deutscher Apotheker Verlag, Stuttgart, 2006 - Remington: Essentials of Pharmaceutics, edited by Linda Felton, Pharmaceutical Press 2012 - Herzfeldt C.D. und Kreuter J. (Hrsg.) Grundlagen der Arzneiformenlehre, Springer Verlag, Berlin 1999 - Leuenberger (Hrsg.) Martin - Physikalische Pharmazie,4, Auflage Wissenschaftliche Verlagsgesellschaft, Stuttgart 2002 - Bauer K.H., Frömming K.-H., Führer C., Lehrbuch der Pharmazeutischen Technologie, 8. Auflage, Wissenschaftliche Verlagsgesellschaft, Stuttgart, 2006 - relevant publications for each area of interest
General Information
- Language
- English
- Levels
- MSC
- Frequency
- Yearly recurring
Examination
- Type
- graded semester performance
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise |
Drug Product Development
Permission from lecturers required for all students.
Block course (see special program)
Room HCP E47.2
|
No time listed | 28 h semesterly |
Offered In
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Industry-Specific Training (Please consult schedule on the website of the study programme )
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