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CPTP4 > Intro > Flashcards

Intro Flashcards

1
Q

Drug Development

A

Takes 10-15 years, 3 clinical development stages

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2
Q

Pre Clinical Development

A

Establish Pharmacological action, Safety in animals

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3
Q

Required before first time in man studies Drug Development

A

Pharmaceutical and analytical studies

Safety Pharmacology, Toxicology and toxicokinetic studies at least 2 preclinical species

Drug metabolism and distribution

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4
Q

Phase 1 studies Drug Development

A

Usually healthy volunteers
Confirm pharmacology established from animal studies
n = 20-50 over ~ 1 year

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5
Q

Phase 2 studies Drug Development

A 
Wider use in patient groups
Establish potential therapeutic value 
Determine effective dose range
Explore common adverse effects
n = 50-300 over ~ 2-5 years
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6
Q

Phase 3 studies Drug Development

A 
Large scale trials in patient groups, 
Comparisons with placebo 
Establish clinical benefit
Establish common adverse effects 
n = 500-2000 over 2-4 years
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7
Q

Basis of licensing decisions

A

Quality
Efficacy
Safety

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8
Q

Drugs with narrow Therapeutic index (often have interaction issues)

A 
Carbamazepine
Corticosteroids*
Ciclosporin
Digoxin
Lithium
Methotrexate
Oral contraceptives*
Phenytoin
Sulphonylureas
Theophylline
Warfarin
* reduced levels a problem, high levels less likely to be
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9
Q

Digoxin Monitoring

A

Therapeutic range 1.0-3.8 nmol/l (0.8-2.0 ng/ml)
Steady state after 7 days (t1/2 ~ 36 hours)
Time of sampling at least 6h after previous dose
Immunoassay can cross-react with other drugs e.g spironolactone
Unreliable for 10 days after use of digoxin antibodies (Digibind)

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10
Q

Gentamicin Monitoring

A

Bactericidal efficacy directly related to peak concentration. Unlikely below 5 mg/l (peak)

Ototoxicity and nephrotoxicity related to total drug exposure.

Concentration above which toxicity more likely: 12 mg/l (peak) & 2mg/L (trough)

Peak level: 1hr after I.M dose or ½ hr after I.V dose

Trough level: just before the next dose

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11
Q

Phenytoin

A

Plasma concentration closely related to acute rather than long-term adverse effects
Therapeutic range 40-80 mol/l (10-20mg/l)
Steady state in 2 weeks, longer the higher the dose
Little fluctuation in plasma concentration; therefore timing of sampling of little significance
Free phenytoin level sometimes useful e.g. liver/renal disease, drug interactions
Why?
Highly protein bound to albumin may be displaced by other drugs
Total level may be therapeutic, free level toxic

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12
Q

Adverse drug reactions

A

response to a drug that is noxious and unintended and that occurs at doses normally used for prophylaxis, diagnosis, or treatment of disease or for modification of physiological function

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13
Q

Most common drug and ADRs causing hospital admission

A

NSAIDs

Diuretics

Warfarin

ACE /AII inhibitors

Beta blockers

Opiates

Digoxin

Prednisolone

Clopidogrel

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14
Q

ADR NSAIDS

A

(GI complications, Cerebral haemorrhage, renal impairment, wheezing, rash)

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15
Q

ADR Diuretics

A

Renal impairment, hypotension, electrolyte disturbances, gout

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16
Q

ADR Warfarin

A

bleeding

17
Q

ADR ACE Inhibitors

A

Renal impairment, hypotension, electrolyte disturbances

18
Q

ADR Beta Blockers

A

Bradycardia, heart block, hypotension, wheezing

19
Q

ADR Opiates

A

Constipation, vomiting, confusion, urinary retention

20
Q

ADR Digoxin

A

toxicity

21
Q

ADR Prednisolone

A

GI complications, hyperglycaemia, osteoporotic fracture

22
Q

ADR Clopidogrel

A

GI bleeding

23
Q

ADR Clasifications

A 
Augmented
Bizarre (Idiosyncratic)
Chronic treatment effects
Delayed effects
End-of-treatment
24
Q

ADR Augmented

A

Dose-related and predictable Avoidable
insulin causing hypoglycaemia
warfarin causing bleeding
nitrates causing headaches

25
Q

ADR Bizarre (Idiosyncratic)

A 
not-dose
related and not predictable
Penicillin:		anaphylaxis
Halothane:		hepatitis
Chloramphenicol:	agranulocytosis
26
Q

ADR Chronic treatment effects

A

Variable, occur with prolonged but not short duration treatment
osteoporosis with steroids
Steroid-induced Cushing’s syndrome
Phenothiazine-induced tardive dyskinesia
Fenfluramine-induced pulmonary hypertension

27
Q

ADR Delayed effects

A

Variable, occur some time after discontinuation of treatment
Drug-induced fetal abnormalities
Drug-induced cancers (recipients or offspring)

28
Q

ADR End of treatment

A

Variable, effects occur on withdrawal of a drug
Adrenocortical insufficiency after steroid treatment
Drug withdrawal seizures
Withdrawal reactions following paroxetine

29
Q

Drug Interactions

A

A clinically meaningful alteration in the effect of one drug (Object) as a result of co-administration of another drug, food or chemical (Precipitant)
Only normally clinically relevant with drugs with narrow TI

30
Q

Pharmacogenetics

A

is the study of genetic basis for variability in drug response

31
Q

Pharmacodynamic Interactions

A

Drugs act on the same target site of clinical effect (receptor or body system)
Opiates and benzodiazepines causing respiratory depression

32
Q

Pharmacokinetic

A

Altered drug concentration at target site of clinical effect
ADME
OCP failure with antibiotics

33
Q

Physicochemical interactions

A

Direct chemical interaction; reduced absorption

Antacids form insoluble complexes with tetracyclines, quinolones, iron, bisphosphonates

34
Q

Distribution interactions

A

Drugs bound in albumin (inactive) displaced by another drug and lead to toxicity

High protein binding – warfarin, phenytoin, statins, amiodarone, diazepam, NSAIDs, heparin, furosemide

35
Q

Metabolism Interactions

A

CYP 450 Enzyme inducers accelerate metabolism  reduced effect

CYP 450 Enzyme inhibitors slow metabolism  enhanced effect

36
Q

INDUCERS

A 
Phenytoin
Carbamazepine
Barbiturates
Rifampicin
Alcohol (chronic)
St John’s Wort
37
Q

INHIBITORS

A 
Cimetidine
Erythromycin / Clarithromycin
Ciprofloxacin
Sulphonamides
Isoniazid
Verapamil
Metronidazole
Omeprazole
Grapefruit juice
Alcohol (acute)
Amiodarone
Antifungals
Sodium Valporate

CPTP4 (1 decks)

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