Pharmacology Basics Flashcards
Definition:
USP-NF
United States Pharmacopoeia National-Formulary
Defintion:
FDA
Food and Drug Administration
In the FDA approval process, who is the pre-clinical investigation done on?
Animals or Cells
Why is the pre-clinical trails always deemed incunclusive?
It has not been experimented on humans yet
How many phases are in the FDA approval process?
4 phases
When does a trail often die out in the FDA Approval process? And what are the statisitcs?
Phase 2 and Phase 3
In phase 2 there is a 33% success rate and in phase 3 there is a 25%-35% success rate.
Phase 1 of FDA Approval Process
Participants:
Time Frame:
What is it studying?
Success Rate:
20-80 participants
Several Months
Studies Saftey
70% Success Rate
Phase 2 of FDA Approval Process
Participants:
Time Frame:
What is it studying?
Success Rate:
100-300 Participants
Up to Two Years
Studys Efficacy
33% Success Rate
Phase 3 of FDA Approval Process
Participants:
Time Frame:
What is it studying?
Success Rate:
1000 to 3000 Participants
1-4 Years
Studies Safety, Efficacy, and Dosing
25%-35% Success Rate
Phase 4 of FDA Approval Process
Participants:
Time Frame:
What is it studying?
Success Rate:
Thousands of Participants
Over 1 Year
Studies Long term effectiveness, cost effectiveness
70%-90% Success Rate
Why is phase 4 significant?
By phase 4, it is basically approved and being sold
What do pharmaceutical companies do in regards to clinical trails?
-Fund Trails
-Track Effects
-Full Honest Disclosure
-Comply with FDA ruling
-Must Prove the Drug Benefit
-Must Define the Risks
How many phases before a sponsor can submit their treatments to the FDA for consideration to be sold on the market.
must past the third phase
FDA and CDER in regards to clinical trials
-Review Trials
»Look at how they were conducted
-Grant Permission
-Allow Fast Track to Drugs that Show Promise
-Determine Prescription Status
»EX-over the counter, schedule type
-Determine labeling
-Determine Safety Categories
-Remove Unsafe Products (over the counter or prescription)
Definition:
Pharmacokinetics
What the body does to the drug
What are the five routes of administration?
- Oral
- Rectal
- Sublingual
- Transdermal
- Parentarel
Which type of drug administration route is given 80% of the time?
Orally
What are the pros to giving a drug orally?
-cheap
-easy
-can get the drug back if needed
-non-invasive
How fast are oral drugs ingested?
Slower
How are oral drugs ingested?
1) digested and absorbed from stomach/intestines
2) enters the hepatic portal circulation to the liver
3)enters general circulation
Where is the sublingual route?
The drug dissolves underneath the tongue
How is the sublingual administration route of a drug absorbed?
It is absorbed through the mucous membrane into the bloodstream
Where is the transdermal administration route of a drug?
The drug is applied to the skin as a patch and absorbed through the skin
What are the pros and cons of transdermal route of drug adminstration?
Pros: Continuous and long-acting
Cons: May cause irritation
How many type of parenteral injection are there? And what are they and the angles given?
1) IV (into the vein) **25 degree angle
2) IM (into the muscle… ex-vaccine) **90 degree angle
3) SQ (subcutaneous…into the fat…ex-insulin) ***45 degree angle
4) Intrathecal (around the spinal cord) ?
Which is the fastest route of administration of a drug?
Parenteral
Pros and cons of the drug administration route: parenteral
Pros:
- Produces a more rapid response
- avoids unpredictable absorption from the GI tract
- fastest
Cons:
- It is costly
- It can not be retrieved once given
- It is considered more invasive
Which drug administration routes go straight to the systematic circulation?
1) Intravenous
2) Sublingual
3) Rectal
What types of food effect oral absorption?
High Fat Meals—
they take longer to digest and therefor longer absorbtion
What type of emotions effect oral absorption?
Pain and Stress:
It triggers a sympathetic nervous response (fight or flight) which slows down absorbiton
Oral Absorption Route
-Take the Drug
-Goes into the Mouth
-Goes to the Stomach
-Goes to the Intestines
-Goes into portal circulation (nutrient rich blood between the gut and liver where liver can remove harmful substances)
-Goes into systematic circulation (provides functional blood supply to tissues all over the body)
Defintion: Absorption
“Process of moving drug from site of administration into circulation”
In what ways do drugs move throughout the body
-passive
-facilitated
-active trasnport
Drugs move by diffusion, high to low concentration
What can 7 things can effect absorption?
1) Blood Flow
2) pH of environment
3) GI motility
4) Stress
5) Age — the older you are, the slower the absorption
6) Disease State
7) Co-administered drugs or food
Definition:
Bioavailability
The portion of the drug that Is able to produce a pharmacologic response
Ex) Steroids are more bioavailable when taken orally
Ex) Insulin orally will not work and has no bioavailability
Which route of administration has the “first pass effect”
ONLY oral meds
What is the first pass effect
It allows the liver to metabolize or inactivate the drug and harmful substances before it is distributed to the body
True or False:
Drugs can not get metabolized before adequate plasma concentrations are reached
False
How does the first pass effect change the concentrations of the active drug?
It reduces the concentration of the active drug before reaching its site of action or systemic circulation
Definition:
Distribution
The process of moving a drug throughout the bloodstream (circulatory system) to target receptors
What does the amount of distribution to target cells depend on?
Physical and chemical properties of the drug
Ability to penetrate cell membranes, capillary, and blood brain barriers
Where does water soluble drugs go?
Goes into the blood
Where do lipid soluble drugs go?
Goes into the tissues
does water soluble or lipid soluble drugs clear quicker out of the body?
Water soluble clears quicker out of the body
Can water soluble drugs go through pores? membrane?
They are super tiny and can go through pores but get repelled by the membrane
How do water soluble drugs concentrate the blood?
They become ionized (electrical charge) and concentrate in the blood
Where do lipid soluble drugs go to?
Lipophilic drugs will deposit in cellular space and fatty-tissues and have a greater volume of distribution
True or False:
Lipid soluble drugs are non-ionized
True
They do not have an electrical charge
What parts of the body can lipid soluble drugs cross?
They can cross pores, cell membranes, and the blood brain barrier
How would you deal with an infant with little fat when giving a lipid soluble drug?
You would need to give the infant a higher concentration of the drug
Only lipid soluble drugs can pass the blood brain barrier because…
1) It Is not ionized and therefor not reflected at the membrane
2) The blood brain barrier is hydrophobic
The brain has a higher blood flow than the skin so if the drug can break the BBB there is…
a higher concentration of the drug in the brain
What parts of the body have a higher capillary permeability?
The Liver
Has an abundance of capillaries which allows a lot of drugs to flow through
Q: Aspirin and Warfarin are both in the blood stream. Warfarin fits better into the protein than aspirin does. Which of the drug are there more of in the bloodstream now?
Aspirin
What are some types of plasma proteins?
-albumin
-glycoproteins
-lipoproteins
What do drugs bind to in the blood?
Plasma Proteins
How a drug binds to a plasma protein deteremains the extent of the…
1) drug distribution
2) elimination rate
Only unbound or free drugs may…
-diffuse into capillary walls
-produce a pharmacologic effect
-be metabolized
-be excreted
***while bound to a protein, the drug is useless