Pharmacology/Clinical studies at Universität für Bodenkultur Wien

• Pharmakon/Wirkstoff -> any substance that has an influence on the human body
• Arzneistoff -> a substance that has an effect on the body + that has therapeutic/diagnostic use
• Arzneimittel -> in a prepared form , ready for administration

• What does the pharmakon to the human body?
• What does the human body to the pharmakon?

Then it gets an "International Freinamen" or generic name.

The discoverer chooses it, the WHO approves it.

It means, that the drug gets transferred to a very fine pulver state, by either grinding or spray drying for example. This enables better absorbtion by higher surface/volume ratio.

• Mexalen -> Handelsnamen, Arzneimittel
• Paracetamol -> Internationaler Freiname, Arzneistoff

• First: Originator
• Copies: Generikum

Galenik deals with the optimum formulation of an API. 

It is of special importance, since it has a great influence, where and how fast a drug is taken in.

The ATC code is a certain way to name drugs and their use.

This allows international comparison and communication, in case, e.g. the exact API is not available, one can still identify a similar drug with a very similar ATC code.

The AMG, the "Arzneimittelgesetz"

In the shape of a SmPC, also summary of product characteristics.

The EMA, and the responsible national agency.

E.g. Ages or the Bundesinstitut für Arzneimittel (BfArM)

Pharmakodymanics: How does the drug influence the human?

• Molecular mechanism of action
• Prove of therapeutic use
• Main effects
• Other effects (side-effects)
• Dosing of the drug + effects of dosing
• Are there any dose-independent side effects like allergic reactions

Pharmakokinetics: How does the human effect the drug?

• ADME
  • Absorption
  • Distribution
  • Metabolism
  • Excretion