LFU:online

Relevant and applied aspects of pharmaceutical chemistry and technology including aspects for drug optimization, stability; drug analytics quality control including validation and GLP aspects; types of drug substances including Biologics, Advanced Therapy Medicinal Products (ATMP) and vaccines, industrial perspective

• Pharmaceutical preformulation: basic concepts of solid pharmaceutical substances, their solid-state forms and their characteristics
• Design and production of dosage forms for different routes of administration including biopharmaceutical aspects
• Modified release drug delivery systems, innovative dosage forms (micro-and nanoparticles, liposomes, micelles, cyclodextrins inclusion complexes, etc.), 3D printed pharmaceuticals and Devices
• Specifications, characterization and quality control of dosage forms, pharmaceutical stability testing
• Required compound properties (and surrogate descriptors such as PhysChem properties)
• Hit finding, validation, and follow up
• Multiparameter compound optimization
• PK/PD profiles
• Work culture and required expertise and resources
• Analytical validation:  Validation of analytical methods in theory (i.e. meaning and relevance of individual validation parameters, their assessment and interpretation)
• Biologics, ATMPs, Vaccines, Radiopharmaceuticals
• Industrial perspective of Drug Substance Production, Formulation development, Process development and implementation in commercial scale and validation (GMP)
• Quality control, release, GLP and stability

Vorlesung (Computer-unterstützte visualisierte Präsentation, online Handouts)

written exam