Pharmacokinetics / Pharmacodynamics - FORNO

Question 1

What is the goal of pharmacovigilance?

Answer 1

Ensure continued safety and effectiveness of animal drugs once they are being used in wide + diverse populations

Question 2

What makes up the pre approval process?

Answer 2

1. Control trials
2. Field trials

Question 3

What is the purpose of the pre approval process?

Answer 3

1. Used to complete safety profile
2. Helps ensure that drug product labeling in adequate and accurate

Question 4

What is a side effect?

Answer 4

Any unintended effect of a pharmaceutical product occurring at doses normally used

** related to pharmacological properties of the drug

Ex: Glucocorticoids cause PU/PD

Question 5

What is an adverse drug reaction?

Answer 5

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

Question 6

Adverse drug events may be related to:

Answer 6

1. Drug-drug interactions
2. Drug-food interactions
3. Drug-disease interactions
4. Idiosyncratic effects
5. Pharmacological effects of the drug
6. Individual patient factors
7. Product defects
8. Etc …

Question 7

What information regarding pharmacovigilance will be on a drug label?

Answer 7

1. Field effectiveness study stating adverse reactions
2. Post- approval experience
3. Contact info - for reporting adverse drug events

Question 8

True or False: Adverse drug events should be reported even with extra label use

Answer 8

TRUE

Question 9

True or False: In the US, ADE reporting by veterinarians and consumers is mandatory

Answer 9

FALSE - voluntary

Question 10

ADE reporting can involve?

Answer 10

1. Approved or unapproved animal drugs
2. Human drugs used to treat animals
3. Events where humans are exposed to animal drugs
4. Events related to devices used in animals

Question 11

Adverse drug experience includes but is not limited to:

Answer 11

1. Adverse event occurring in animals using animal drug products
2. Failure of new animal drug to produce its expected clinical effect
3. Adverse event occurring in humans from exposure or use of a new animal drug

Question 12

What classifies a type A adverse drug reaction?

Answer 12

1. Predictable
2. Occurs in 1 or more species
3. Correlated with plasma drug conc.
4. High frequence
5. High morbidity/Low mortality
6. Reversible by reducing dose or withdrawing drug

Question 13

What classifies a type B adverse drug reaction?

Answer 13

1. Idiosyncratic
2. NOT dose dependent
3. Individual rxn
4. Unpredictable
5. Serious + life threatening
6. 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

Question 14

What is the minimal therapeutic dose?

Answer 14

smallest dose that creates a therapeutic effect

** also called the LOWEST EFFECTIVE DOSE (LED)

Question 15

What is ED50?

Answer 15

Effective dose 50

therapeutic effect in 50% of animals

Question 16

What is ED99?

Answer 16

Effective dose 99

therapeutic effect in 99% of animals

Question 17

What is the maximal therapeutic dose?

Answer 17

Largest dose tolerated without toxic effects

Question 18

___________ is the range of plasma concentration in which most patients have the desired drug effect with minimal toxicity

Answer 18

Therapeutic range / window

Question 19

What is LD50?

Answer 19

Lethal dose 50

Causes death in 50% of animals in an experimental group

Question 20

What is LD1?

Answer 20

Lethal dose 1

Causes death in 1% of animals in an experimental group

Question 21

What is the therapeutic index?

Answer 21

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)

Question 22

How is therapeutic index calculated?

Answer 22

Toxic dose in 50% of pop (TD50) / Effective Dose in 50% of pop (ED50)

TD50 / ED50

Question 23

What is the margin of safety?

Answer 23

ratio between the amount of drug that is lethal to 1% of population and effective in 99% of the population

TD1 / ED99

Question 24

How is the margin of safety calculated?

Answer 24

TD1 / ED99

Question 25

When would the margin of safety be included on a drug label?

Answer 25

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