Basics of CPTP Flashcards
Define zero order kinetics
Drug will kill a constant number of tumour cells
CLINICAL drug development phase 1
Test in healthy volunteers
confirm phamaokinectics
check for potential drug interactions, doses
CLINICAL drug development phase 2
Test in patients
Establish potential therapeutic value and common adverse effects
CLINICAL drug development phase 3
Large scale trials in patient
Compare with placebo
Establish common adverse effects at planned therapeutic dose
What does licensing take into account when evaluating drug
Risk benefit
doesnt account for cost
Who to report drug interactions to
MHRA
Medicines and Healthcare regulatory agency
Drug rep sales promotion tactics must comply with code of conduct from who
ABPI
Association of British Pharmaceutical Industry
ABCDE of adverse drug reactions
Augmented Bizzare Chronic tx effects Delayed effects End of treatment
AUGMENTED adverse drug reactions
Dose related, avoidable
eg warfarin causing bleeding
BIZZARE adverse drug reactions
Not dose related. Not predictable
(eg
chloramphenicol causing agranulocytosis,
penicillin causing allergy,
carbamezapine causing Steven Johnson)
CHRONIC TX EFFECTS adverse drug reactions
Occur with prolonged tx
eg steroids leading to osteoporosis
DELAYED EFFECTS adverse drug reactions
Occur some time after discontinuation of treatment
eg drug induced foetal anomalies
END OF TREATMENT EFFECTS adverse drug reactions
Occur after withdrawing drug
eg adrenal insufficiency after steroid tx
at which phase are drug developments usually detected
Phase 4