UTMB pharm 1 EXAM WITH VERIFIED
SOLUTIONS
IND
investigational new drug - by the FDA
based on preliminary testing completed on animals
IRB
institutional review board - examines the specifics of a clinical trial, consent issues, patient protection
FDA drug approval process
1. tested on animals for safety
2. IND application that includes plan for testing and composition
3. phase I emphasizes safety, focus is on frequent side effects (20-80 healthy volunteers)
4. phase II emphasizes effectiveness against a placebo (100s of volunteers with the targeted disease)
5. phase III (1000s) studies populations, drug interactions and dosages. here the FDA and drug
sponsor agree on the structure of the phase III studies
6. New drug application: patient insert is submitted for approval, 6-10 months for a decision
Drugs categorized based on potential for
abuse, addition, widely accepted medical use
Schedule I
high risk for abuse, no medical uses
ex: heroin, LSD
Schedule II
high risk for abuse, some medical uses, potential physical and psychological dependence
most restrictive: requires written physical Rx for 30 days only, no Refills
ex: hydrocodone, morphine
Schedule III-V
low risk for abuse, safe medical uses, smaller amounts of narcotics
ex: codeine, butorphanol
Texas prescriptive authority
-delegated by the supervising physician through a formal agreement
-PAs required to have 1) DPS registration number and 2) DEA registration number.
-PAs can only prescribe Schedule III-V. (Hydrocodone was recently moved to schedule II)
-EXCEPTION: PAs can prescribe schedule II in hospital in 1) palliative care and ER 2) and as part of a
terminal illness plan.
-PAs must consult with delegating physician for 1) refills after the initial 90 day supply and 2) for pts
<2 y/o
, Pharmacokinetics
what the body does to the drug:
absorption, distribution, metabolism, elimination
Pharmacodynamics
what the drug does to the body - think how the drug is dynamic in the body
pharmacologic effect
what the drug does once it gets where it needs to go
clinical response
what happens when the drugs acts on its target
therapeutic index
the ratio of the dose that leads to toxic effect in 50% of cases to the dose that leads to therapeutic
effect in 50% of the cases
More Toxic: Narrow therapeutic index aka Digoxin, warfarin, cyclosporine, theophylline
acid absorption
Weak acid is absorbed when pH < pKa
HA form predominates
bioavailability
The amount of drug that reaches systemic circulation, highly dependent on absorption and limited by
first pass metabolism
bioequivalence
two drugs that have comparable bioavailability and similar times to achieve peak blood
concentrations
-FDA says brand and generic must have the same bioequivalence
CYP 450 inhibitors
increase therapeutic drug levels, toxicity is problematic
Azole antifungals (ex. Voriconazole, Fluconazole)
Erythromycin
Cimetidine
Verapamil
SOLUTIONS
IND
investigational new drug - by the FDA
based on preliminary testing completed on animals
IRB
institutional review board - examines the specifics of a clinical trial, consent issues, patient protection
FDA drug approval process
1. tested on animals for safety
2. IND application that includes plan for testing and composition
3. phase I emphasizes safety, focus is on frequent side effects (20-80 healthy volunteers)
4. phase II emphasizes effectiveness against a placebo (100s of volunteers with the targeted disease)
5. phase III (1000s) studies populations, drug interactions and dosages. here the FDA and drug
sponsor agree on the structure of the phase III studies
6. New drug application: patient insert is submitted for approval, 6-10 months for a decision
Drugs categorized based on potential for
abuse, addition, widely accepted medical use
Schedule I
high risk for abuse, no medical uses
ex: heroin, LSD
Schedule II
high risk for abuse, some medical uses, potential physical and psychological dependence
most restrictive: requires written physical Rx for 30 days only, no Refills
ex: hydrocodone, morphine
Schedule III-V
low risk for abuse, safe medical uses, smaller amounts of narcotics
ex: codeine, butorphanol
Texas prescriptive authority
-delegated by the supervising physician through a formal agreement
-PAs required to have 1) DPS registration number and 2) DEA registration number.
-PAs can only prescribe Schedule III-V. (Hydrocodone was recently moved to schedule II)
-EXCEPTION: PAs can prescribe schedule II in hospital in 1) palliative care and ER 2) and as part of a
terminal illness plan.
-PAs must consult with delegating physician for 1) refills after the initial 90 day supply and 2) for pts
<2 y/o
, Pharmacokinetics
what the body does to the drug:
absorption, distribution, metabolism, elimination
Pharmacodynamics
what the drug does to the body - think how the drug is dynamic in the body
pharmacologic effect
what the drug does once it gets where it needs to go
clinical response
what happens when the drugs acts on its target
therapeutic index
the ratio of the dose that leads to toxic effect in 50% of cases to the dose that leads to therapeutic
effect in 50% of the cases
More Toxic: Narrow therapeutic index aka Digoxin, warfarin, cyclosporine, theophylline
acid absorption
Weak acid is absorbed when pH < pKa
HA form predominates
bioavailability
The amount of drug that reaches systemic circulation, highly dependent on absorption and limited by
first pass metabolism
bioequivalence
two drugs that have comparable bioavailability and similar times to achieve peak blood
concentrations
-FDA says brand and generic must have the same bioequivalence
CYP 450 inhibitors
increase therapeutic drug levels, toxicity is problematic
Azole antifungals (ex. Voriconazole, Fluconazole)
Erythromycin
Cimetidine
Verapamil
