Pharmacology/Clinical studies at Universität für Bodenkultur Wien

Flashcards and summaries for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien

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Study with flashcards and summaries for the course Pharmacology/Clinical studies at the Universität für Bodenkultur Wien

Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

Difference :

  • Pharmakon/Wirkstoff
  • Arzneistoff
  • Arzneimittel

Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

What are the 2 main questions that the pharmacology deals with?

Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

How is a drug called, once the pharmacological studies justify the transfer to a developmental stage?

Before, it gets just a codename "e.g. 2743847"

Who chooses this name?, Who approves it?

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Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

What means "mikronisiert" as a drug preparation step?

Why is it done?

Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

What is the difference between

  • Mexalen
  • Paracetamol

? What kinds of names are they, and what do they represent?

Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

What are names for the first drug and its copies?

Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

What is "Galenik" and why is it very relevant in terms the drugs pharmacology?

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Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

What is the ATC code? Why is it usefull?

Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

What legislative foundation determines the development and controll of drugs in austria and germany?

Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

In what format ist the properties of a new drug/API documented fo apply for approval in the EU?

Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

Who has to aprove the SmPC in the EU?

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Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

What has to be elaborated in an SmPC?

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Exemplary flashcards for Pharmacology/Clinical studies at the Universität für Bodenkultur Wien on StudySmarter:

Pharmacology/Clinical studies

Difference :

  • Pharmakon/Wirkstoff
  • Arzneistoff
  • Arzneimittel
  • 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

Pharmacology/Clinical studies

What are the 2 main questions that the pharmacology deals with?

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

Pharmacology/Clinical studies

How is a drug called, once the pharmacological studies justify the transfer to a developmental stage?

Before, it gets just a codename "e.g. 2743847"

Who chooses this name?, Who approves it?

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

The discoverer chooses it, the WHO approves it.

Pharmacology/Clinical studies

What means "mikronisiert" as a drug preparation step?

Why is it done?

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.

Pharmacology/Clinical studies

What is the difference between

  • Mexalen
  • Paracetamol

? What kinds of names are they, and what do they represent?

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

Pharmacology/Clinical studies

What are names for the first drug and its copies?

  • First: Originator
  • Copies: Generikum

Pharmacology/Clinical studies

What is "Galenik" and why is it very relevant in terms the drugs pharmacology?

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.

Pharmacology/Clinical studies

What is the ATC code? Why is it usefull?

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.

Pharmacology/Clinical studies

What legislative foundation determines the development and controll of drugs in austria and germany?

The AMG, the "Arzneimittelgesetz"

Pharmacology/Clinical studies

In what format ist the properties of a new drug/API documented fo apply for approval in the EU?

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

Pharmacology/Clinical studies

Who has to aprove the SmPC in the EU?

The EMA, and the responsible national agency.

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

Pharmacology/Clinical studies

What has to be elaborated in an SmPC?

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

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