Preclinical Studies Flashcards
What is the common reason for attrition during the pre-clinical phase?
Toxicology.
What are 5 R’s addressed during drug development?
1 - Right Target 2- Right Tissue 3- Right Safety 4- Right Patient 5- Right commercial potential
What is the definition of a drug target?
These are targets which the molecule binds onto in order to produce a desirable effect.
What is the common route taken for a drug target?
DNA - RNA - Protein
What is the definition of tissues?
Group of specialised cells carrying out A specific function.
What is the definition of organs?
Groups of specialised cells carrying out specific functions.
What is the definition of IN - VIVO?
Experimentations inside an intact living organism.
What is the definition of IN - VITRO?
Experimentations outside an organism in test tubes.
What is the definition of EX - VIVO?
Experimentations of intact tissues / organs outside living organisms.
What is the definition of IN - SILICO?
Experimentations using computer simulation.
Name some advantages of in - vitro procedures.
High throughput screening = screening known compounds from libraries.
Reduced cost.
Less regulations.
What does the in - vitro cell line based testing involve?
- Cell Biology
- Mechanism of action
- Toxicology
Name some disadvantages of in - vivo procedures
Highly regulated
Low throughput screening.
What does the in - vivo cell line based testing involve?
Small animals are used.
- Complex disease mechanisms
- Overall effects on intact living organisms
- Effect of other organ systems and counter - regulatory mechanisms
- Pharmacokinetics
- Safety
- Mandatory before human testing
What is a cell line?
Permanently established cell culture which will proliferate indefinitely given appropriate fresh medium alongside space.