Midterm prep Flashcards
the 5 key steps in the drug development process
basic research and drug discovery
preclinical trials
clinical trials
health canada review and manufacturing
post market surveillance and phase IV clinical trials
basic research involves
identification of the target
studying of the target
preclinical studies involve
pharmacology studies - mechanism of action
toxicology studies
compare phase 1, 2 and 3 trials
- Phase 1 (proof of safety)
○ Tests the absorption, distribution, elimination and adverse effects of the drug - the tolerability
○ Conducted in a limited number of healthy volunteers, do not assess the efficacy of the drug - Phase 2 (methodology)
○ Look to determine whether the drug is effective in treating the condition for which it is recommended
○ Safety of drug
○ Patients have the disease–
Phase 3 (investigation)
○ Randomized control trials
○ Used for the licencing and marketing of the drug
○ How safe and effective compared to placebo or current treatment
what composes drug action
drug targets, therapeutic range, drug response and efficacy/potency
what is threshold of effect
Once this threshold is reached, small increase in dose will result in a large increase in response (therapeutic doses)
efficacy vs potency
- Efficacy
○ The maximum pharmacological response that can be produced by a specific drug in that biological system- Potency
○ The dose of a drug that is required to produce a response of a certain magnitude - usually 50% of the maximal response
- Potency
what are the 3 ways to administer a drug
topical (inhalation or the skin)
enteral (GI tract)
parenteral (bypasses GI tract)
adverse effects of drugs
-extension of the therapeutic effect (overdose)
-unrelated to main drug action (Nausea)
-allergic reaction
-withdrawal/addiction
-teratogenesis
-adveerse biotransfomation reaction
list some drug-food interactions
tyramine (found in well mature cheeses)
- MAO interaction with antidepressants and raises blood pressure
grapefruit
-alter absorption, inhibit enzymes that inactivate drugs
what part of the brain is often misuses with drugs/associated with addiction due to its dopaminergic reward centers
limbic system - hypothalamus
how do drugs cross membranes
- Passive diffusion
○ Most prevalent- Active transport
○ Channel mediated - Filtration via pores
Only for very small drugs that are water soluble
- Active transport
what is biotransformation
the conversion of a drug to a different chemical compound in order to eliminate it
ways drugs can be excreted
§ Majority from kidney
§ GI tract
§ Volatile or gaseous can be excreted by the lungs
§ Saliva and sweat
what is bioavailability
- The fraction of an administered dose that reaches systemic circulation in an active form
- In percent
what are the catecholamines
dopamine - addiction (motivation and reward)
norepinephrine - excitatory
do stimulants increase or decrease serotonin at the synapse
increase
what response do cholinergic (acetylcholine) receptors do
excitatory
there is nicotinic and muscarinic receptors
general criteria for SUD
risky use
social impairments
impaired control
withdrawal
tolerance
what is addiction
- A state in which stopping or abruptly reducing the dose of a given drug produces non physical symptoms
characteristics of addictive drugs
increase dopamine
induce novelty
reduce anxiety
name some stimulants
cocaine
amphetamines
nicotine
caffeine
describe drug withdrawal symptoms
- Stimulants
○ Sleepiness, muscle pain, anxiety, tremors, low mood, suicidal ideations and cardiovascular problems in some cases- Opioids
○ Sweating, muscle aches, agitation, diarrhea, abdominal cramping, vomiting
- Opioids
describe drug tolerance
Repeated administration of a given dose has less and less pharmacological effect OR drug must be increased to get the same effect
