Summary: Drug Development

Read the summary and the most important questions on Drug development

• Introduction of the course

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• What is the definition of a drug?

  A drug can be defined as any chemical substance that can be used in the medical diagnosis, cure, treatment or prevention of the disease. 
  
  A drug is a compound with a pharmacological activity:
  - It influences processes in the body
  - A receptor is most of the time involved
  - adverse effects are often related to the main effect

• What is the drug development triangle?

  It has 3 points: Disease, drug and human. 
  1: The disease pathology  goes from Disease to Human.
  2:  The repair/ defense mechanisms go from Human to Disease
  3: The mechanism of drug action goes from Disease to Drug
  4: The drug resistance / inactivation goes from Drug to Disease 
  5: The pharmacokinetics go from Human to Drug  
  6: The Toxicity go from Drug to Human

• What kind of knowledge requires the Drug development?

  - Normal behavior of the human body
  - Basic mechanisms leading to the disease
  - Molecular players involved in disease progression
  - Chemistry/ construction of drugs
  
  chemistry, mathematics, physics, cell biology, molecular biology, pathology

• What are the phases in the drug development?

  Firstly, there are two main phases; the preclinical and the clinical phase. 
  - The preclinical phase can be divided into the drug discovery phase and the preclinical development phase.
  -  The clinical phase can be diveded into  phase 1, 2 and 3.
  - After those phases a phase 4 exist that is focused on the post marketing surveillance.

• What is the length of all phases?

  Preclinical = 2-4 years
  regulatory review= 2-6 months
  Clinical: 3-4 years
  Regulatory review 1-3 years
  In total it can take 10-13 years

• Which instances are involved in the first stage of the drug development? (drug discovery)

  - Pathology, pathophysiology, pharmacochemistry, High throughput screening, molecular modeling, pharmacodynamics.

• Which instances are involved in the second stage of the drug development? (Preclinical development)

  Drug targeting, Pharmaceutical phase, Pharmacokinetics (ADME). In vitro  versus  in vivo toxicology.

• The clinical phase consist of ..

  phase 1: clinical trials with healthy volunteers (or in patients in case of severe adverse side effects). But also long term toxicology studies in animals and formulation research
  phase 2:  small scale trials in patients to assess the efficacy and the dosage. But also long term toxicology studies in animals and formulation research. 
  phase 3: Large-scale controlled clinical trials but also long-term toxicology studies in animals and formulation research.  
  phase 4: post marketing surveillance. (officially, it does not belong to the clinical phase)

• How goes the softenon story?

  Softenon/Thalidomide has sedative effects and in the 50ths and 60ths many pregnant women used the medicine as during the first three months of their pregnancy.  During these three months the limbs of the baby were formed and the drug very badly involved this process. As a result  there were many baby's with abnormal limbs.Although in humans the drug seemed to be toxic in rats it was not. So this story learned us that extrapolation from animal to human is not always possible.

• Who came up with the receptor idea?

  Paul ehrlich. Agents do not act unless they are bound. 
  He got the Nobel prize for medicine in 1908.  
  The first synthetic medicine was sythesized in 1910 and it was called salvarsan and it contained arsenic!