Pharmacology L2 Flashcards
(36 cards)
Stages of drug discovery& development
- drug discovery
- preclinical development
- clinical development
Drug discovery
Identification of candidate molecules based on their pharmacological, biochemical and physiochemical properties
Preclinical development
Non-human studies to determine basic pharmacokinetics, potential toxic side effects and formulation. These can take a long time
Clinical development
Evaluation of drug safety, side effects, efficacy and optimum dosage in volunteers and patients
Stages of drug development
- chemical or biochemical synthesis of novel compound
- isolation of active ingredient from natural source
- production and isolation of biologicals
- preclinical testing 1/2/3
- phase 0/1/2/3
- approval
Chemical or biochemical synthesis of a compound involves what?
Screening of the compound
Pre-clinical testing 1b involves?
Effects of drug on cellular function. How does it affect biological response? Is it an agonist, antagonist, modifier?
Pre-clinical testing 2 involves?
Mechanism of drug action. Is it blocking a pathway or is there a reaction
Pre-clinical testing 3 involves?
Toxicity testing ( in vivo, in vitro & ex vivo)
Phase 0 is what?
Human microdosing
What does phase 0 entail
Small amount of volunteers use non-pharmacological doses to see if there are any effects on cellular function, drug action and toxic side effects
What does phase 1 entail
Does the drug have any effects on body function, drug safety, unexpected side effects
What is phase 1
Clinical trial on healthy subjects (very small no;10-80)
What is phase 2
Clinical trial on small number of selected patients (100-300)
What does phase 2 entail
Effect on pathophysiology of the disease, therapeutic dosage.
What is phase 3
Clinical trial on diverse large group of patients (>1000)
Approval of drug development is usually carried out by?
Licensing by National regulatory agency
Regulatory agency in US and Europe
US- FDA (world standard)
EMA- European Medicines Agency
What is phase 4?
Post-licensing phase
Clinical trial: long-term benefit-risk evaluation
Large and extremely diverse patients
What does phase 4 entail?
Pharmacovigilance; determination of therapeutic value of novel drug or delivery system. Adverse effects in previously untested patient groups
What does phase 3 entail?
Comparison to other therapies and placebos
When do medical and ethical approval occur?
Before clinical development
When does regulatory approval occur?
Before post-licensing surveillance
Most drug targets are proteins like?
- receptors
- transporters
- enzymes
