1.Lesson

Question 1

What are Clinical trials?

Answer 1

Question 2

The drug development process for Originators?

(Wie eine Studienverlauf aussieht - neues Medikament entwickelt)

Answer 2

* Unterteilungen

• Pre-discovery 3-6 years
• Clinical trials 6-7 years
  
  • 4 Phase 0.5 -2 years

Question 3

Clinical phases

Tell me more about it

• How many are there?

What happens?

Answer 3

Question 4

Phase 1 Clinical Trails

Answer 4

• Check the safety/tolerability
  
  • Pharmacokinetics = What the body does to the drug
  • Pharmacodynamics = What the drug does to the body

Question 5

Pharmacokonetics

• 4 Abläufe (Bild )

Answer 5

Ablauf:

Einnahme, Absorption, Metabolism, Distribution, Excretion

Question 6

Pharmacokinetics

Absorption - Elimination phase

Answer 6

Halbwertzeit : Zeit in dem sich das Medikament in Blut reduziert 50% 25%

Verlängerte Halbwertzeit

AUC= Grosse AUC , grösserer Schutz

Clearence = Wie schnell das Medi ausgeschieden oder abgebaut wird, steht Eng im Zusammenhang mit dem AUC - niedrige Clearence : Medi wird langsam abgebaut = daher lange im Körper

(Blood samples)

Question 7

Medication application forms

Answer 7

i.v = Does not have absorption time , directly

Question 8

Therapeutic range

Answer 8

Question 9

Phase 2 Clinical trail

Answer 9

Question 10

Phase 3 Clinical Trial

Answer 10

(Use often placebo here in the second group)

Question 11

Phase 4 Clinical Trail

Answer 11

Phase 4 only possible if the drug is on the market / available in public (auf dem Markt)

Sponsoren often like to do this, because they would like to show that his drug is the best one

Question 12

Basic study designs

(Gold standard: RCT)

Tell me the different type of control treatment:

(Groupe A Medi & Groupe B ?)

Answer 12

1. Placebo
2. no treatment
3. different does or regimen of the study treatment or
4. a different active treatment

( But for example, no treatment is not always possible like = fake surgery)

Question 13

Basic study designs

Most prominent study design

(Example Drug study)

Answer 13

• Parallel design
• Cross over design
• Factorial design
• Hybrid
• Adaptive

Question 14

Difference between Parallel group & cross over Study

Answer 14

Parallel Group: 4 different groups

Cross over:

A -B: Means 50% Pat take drug A —- after “wash out” than drug B

B-A: Same thing but the Patient first take drug B

Wash out= Blood back to baseline, break between