Pharmacokinetics / Pharmacodynamics - FORNO Flashcards
What is the goal of pharmacovigilance?
Ensure continued safety and effectiveness of animal drugs once they are being used in wide + diverse populations
What makes up the pre approval process?
- Control trials
- Field trials
What is the purpose of the pre approval process?
- Used to complete safety profile
- Helps ensure that drug product labeling in adequate and accurate
What is a side effect?
Any unintended effect of a pharmaceutical product occurring at doses normally used
** related to pharmacological properties of the drug
Ex: Glucocorticoids cause PU/PD
What is an adverse drug reaction?
Response to a medicine which is NOXIOUS + UNINTENDED, which occurs at doses normally used
***NOT related to pharmacological properties of the drug
** some consider adverse effect when admin at higher doses
Adverse drug events may be related to:
- Drug-drug interactions
- Drug-food interactions
- Drug-disease interactions
- Idiosyncratic effects
- Pharmacological effects of the drug
- Individual patient factors
- Product defects
- Etc …
What information regarding pharmacovigilance will be on a drug label?
- Field effectiveness study stating adverse reactions
- Post- approval experience
- Contact info - for reporting adverse drug events
True or False: Adverse drug events should be reported even with extra label use
TRUE
True or False: In the US, ADE reporting by veterinarians and consumers is mandatory
FALSE - voluntary
ADE reporting can involve?
- Approved or unapproved animal drugs
- Human drugs used to treat animals
- Events where humans are exposed to animal drugs
- Events related to devices used in animals
Adverse drug experience includes but is not limited to:
- Adverse event occurring in animals using animal drug products
- Failure of new animal drug to produce its expected clinical effect
- Adverse event occurring in humans from exposure or use of a new animal drug
What classifies a type A adverse drug reaction?
- Predictable
- Occurs in 1 or more species
- Correlated with plasma drug conc.
- High frequence
- High morbidity/Low mortality
- Reversible by reducing dose or withdrawing drug
What classifies a type B adverse drug reaction?
- Idiosyncratic
- NOT dose dependent
- Individual rxn
- Unpredictable
- Serious + life threatening
- Low morbidity/ HIGH mortality
** may be reported in the drug label (Ex: If such signs of sensitivity occur, stop the drug and call the vet)
**must discontinue treatment, lowering dose does not work for Type B reactions
What is the minimal therapeutic dose?
smallest dose that creates a therapeutic effect
** also called the LOWEST EFFECTIVE DOSE (LED)
What is ED50?
Effective dose 50
therapeutic effect in 50% of animals
What is ED99?
Effective dose 99
therapeutic effect in 99% of animals
What is the maximal therapeutic dose?
Largest dose tolerated without toxic effects
___________ is the range of plasma concentration in which most patients have the desired drug effect with minimal toxicity
Therapeutic range / window
What is LD50?
Lethal dose 50
Causes death in 50% of animals in an experimental group
What is LD1?
Lethal dose 1
Causes death in 1% of animals in an experimental group
What is the therapeutic index?
Ratio between the upper/toxic and lower/minimally effective ends of the therapeutic range
Toxic dose in 50% of pop (TD50) / Effective Dose in 50% of pop (ED50)
How is therapeutic index calculated?
Toxic dose in 50% of pop (TD50) / Effective Dose in 50% of pop (ED50)
TD50 / ED50
What is the margin of safety?
ratio between the amount of drug that is lethal to 1% of population and effective in 99% of the population
TD1 / ED99
How is the margin of safety calculated?
TD1 / ED99
When would the margin of safety be included on a drug label?
If the study includes both the recommended dose and overdoses given for the proposed and longer treatment periods
Ex on drug label: puppies given 1,3,5 times the maximum exposure dose
