Module 1: Section 2 Flashcards
(25 cards)
5 Steps
basic research and drug discovery preclinical tirals, clinical trials, health canada reveiw and manufacturing, most market surveillance and phase IV clinical trials
Steps 1-2: drug discovery
(basic research and discovery + pleclinical studes) = 3-6 years
Steps 3-5: Drug development
clinical trials: phase 1 - 3(6-7 years)
Health Canada Reveiw and manufacturing: 0.5 - 2 years
post market surveilence/phase IV: continuous
steps of drug discovery
step 1: identification of the target (eg, receptor that causes relief of pain)
step 2: studying the target
shows promise = lead compound = studied in more depth
efficacy
the maxiumum pharmacological response that can be produced by a specific drug in that biological system
preclinical studied
is is safe and effective
1) pharmacological study
2) toxicological study
pharmacological study
determine detailed mechanism of action of new drug ex is meant to lower blood pressure looks at how - does it constrict vessles?
toxicology study
determine potential risk or harmful effects. all drugs have some toxcicity at some dose in some individuals - very expensive. may take up to 6 years to complete
clinicla trial: inital steps
poof of safety, methodology investigation
phase 1 clinical trial
evaluate absorption, distribution, elimination and adverse effects . efficacy not assesed. conducted in limited number (20-80)
Phase 2
determine if drug is effective for conditioon. limited number of people (100-500). pay close attention to saftey. conducted in patients with the disease designed to treat
phase 3 - RCT (randomized controlled trials)
main study used for licensing anf marketing. large people (1000+) . more diverse population. goal = how safe/effective vs. placebo or gold standard. longer than phase 2 (months to years) . conducted in many places for diversity, cost 1 mil to 50 mil
Design of Phase 3 clinical trials
enrollment, treatment allocation, results
enrollment - target popualtion
group of patients who drug is intended for
enrolment: study population
subset of target population that meets all required criteria - inclusion exclusion criteria
comorbidities
one or more conditions present in addition to primary condition
consent
informed consent must be obtained
treatment allocation - double blind design
neither investigator not subject aware which treatment assigned
treatment allocation: randomization
randomly assigned to treatment groups - counfounfing variables
treatment allocation: control
placebo or gold standard
results : outcome
measures how much drug worked in patient
results: compliance, quality of life, statistics
did patients take drug? adverse effects? compare outcome with control drug -
generic vs brand name
generic name ex acetaminophen
brand name ex. tylenol
bioequivalence
comparative bioequivalence study conducted - compared blood levels of brand vs generic
