EQUIVALENCE AND BODY SYSTEMS Flashcards
Select all that apply
In order to be pharmaceutically equivalent, drug products must have the same:
a) active ingredients
b) inactive ingredients
c) dosage form and strength
d) mechanism of release
e) route of administration
a) active ingredients
c) dosage form and strength
e) route of administration
Drug products that contain the same drug moiety, but may have different forms or strengths are:
a) Pharmaceutical equivalents
b) Pharmaceutical alternatives
c) Therapeutic equivalents
d) Bioavailability
b) Pharmaceutical alternatives
__________ is the measure of the rate and extent to which the active ingredient is absorbed from a dosage form and becomes available at the desired site of action.
Bioavailability
__________ describes pharmaceutical equivalent or pharmaceutical alternative products that display comparable bioavailability when studied under similar experimental conditions.
Bioequivalence
In order for two drugs to be therapeutic equivalents, they first must be:
a) pharmaceutical alternatives and be bioavailable
b) pharmaceutical alternatives and be bioequivalent
c) pharmaceutical equivalents and be bioequivalent
c) pharmaceutical equivalents and be bioequivalent
True or False
Two drugs can only be therapeutic equivalents if their inactive ingredients are identical.
False
active ingredients are identical
To be classified as therapeutic equivalents by the FDA, drugs products must meet which of the following criteria:
a) they are bioequivalent and adequately labeled
b) they are pharmaceutical equivalents
c) they are bioavailable
d) they are approved as safe and effective
e) they are in compliance with Current Good Mfc. Practice regulations
f) they are pharmaceutical alternatives
a) they are bioequivalent and adequately labeled
b) they are pharmaceutical equivalents
d) they are approved as safe and effective
e) they are in compliance with Current Good Mfc. Practice regulation
What is the difference between pharmaceutical equivalents and therapeutic equivalents?
Therapeutic equivalents must also be bioequivalent.
For an applicant drug to be considered bioequivalent to a standard drug, it must be within what percentage range compared to the standard drug bioavailability?
a) -20%/+20%
b) -15%/+25%
c) -20%/+20%
d) -20%/+25%
d) -20%/+25%
What is the actual name of the “orange book”?
Approved Drug Products with Therapeutic Equivalence Evaluations
What is another name for the Approved Drug Products with Therapeutic Equivalence Evaluations resource book?
Orange book
Define the acronym DESI.
Drug Efficacy Study Implementation
What does the letter “A” indicate for drugs in the orange book?
Drug is a therapeutic equivalent product.
What does the letter “B” indicate for drugs in the orange book?
Drugs that are not considered to be equivalent.
Orange Book Ratings.
Drugs which are not considered to have the potential for equivalence problems.
a) AA
b) AB
c) AP
d) AT
a) AA
Orange Book Ratings.
Drugs which have shown, through testing that they are equivalent.
a) AA
b) AB
c) AN
d) AO
b) AB
Orange Book Ratings.
Equivalent solutions and powders for intended aerosolization.
a) AO
b) BP
c) AN
d) AA
c) AN
Orange Book Ratings.
Equivalent injectable oil solutions whose active ingredients and vehicle are identical.
a) AT
b) AP
c) BN
d) AO
d) AO
Orange Book Ratings.
Drugs which are not considered to have the potential for equivalence problems.
a) AP
b) AN
c) AT
d) AB
c) AT
Orange Book Ratings.
Equivalent topical products.
a) AT
b) AP
c) AA
d) AN
b) AP
Orange Book Ratings.
Indicates further testing is needed on a product already assigned to A or B.
a) B*
b) BX
c) BE
d) BT
a) B*
Orange Book Ratings.
Drugs shown to be non-equivalent in bioequivalence studies.
a) BT
b) BS
c) BP
d) BD
d) BD
Orange Book Ratings.
Non-equivalent drug due to presumed differences in delayed release dosage form.
a) BD
b) BE
c) BT
d) B*
b) BE
Orange Book Ratings.
Non-equivalence due to a presumed difference in extended release dosage forms.
a) BS
b) BT
c) BX
d) BC
d) BC
Orange Book Ratings.
Aerosol-Nebulizer drugs that are presumed to be non-equivalent.
a) BC
b) BS
c) BN
d) BE
c) BN
Orange Book Ratings.
Active ingredients which the FDA has determined have potential equivalency problems.
a) BP
b) AP
c) BX
d) BS
a) BP
Orange Book Ratings.
Suppositories or enemas which are presumed to be non-equivalent.
a) AR
b) BR
c) BD
d) BE
b) BR
Orange Book Ratings.
Drugs which do not have a valid standard for comparison.
a) BE
b) BS
c) B*
d) BN
b) BS
Orange Book Ratings.
Topical products which are presumed to be non-equivalent.
a) BC
b) BR
c) AT
d) BT
d) BT
Orange Book Ratings.
Drugs products for which the available data is insufficient to determine equivalence
a) BS
b) BR
c) BX
d) BE
c) BX
Injuries that damage the integrity of the skin barrier.
Skin abrasions/lacerations
Damage caused by contact with heat or sun exposure.
Burns
Abnormal growth of cells in the skin structure.
Skin cancer
Chronic disease that forms scaly red patches on skin.
Psoriasis
Chronic itchy rash.
Eczema
Infection caused by bacteria, virus, or fungal means.
Infection
Major structures of the skin.
Epidermis, dermis, and subcutaneous layer.
Clean-up crew of the blood.
White blood cells
Carries oxygen throughout body using hemoglobin.
Red blood cells
Portion of the blood important in the clotting process when a blood vessel is injured.
Platelets
Soup that blood cells float around in.
Plasma
Two chambers at the top of the heart are known as:
Left and right Atrium
Function of left and right atrium include:
Collect blood returning to heart and forward it to lower chambers.
Which chambers have thicker muscle walls and are more powerful?
Lower chambers
Two chambers at the bottom of the heart are known as:
Left and right Ventricles
Takes blood returned from body tissues through the right atrium and pushes it out to the lungs to get its oxygen supply replenished.
Right ventricle
Takes blood returned from lungs through left atrium and pushes out blood to feed body tissues.
Left ventricle
Conductor on the heart that initiates heart beat by sending electrical impulses across heart muscle.
Sino-atrial node (SA)
Electrical insulating layer of tissue that acts as a bridge separating the upper/lower chambers of the heart.
Atrial-ventricle node (AV)
Which half of the heart receives and distributes non-oxygenated blood?
Right half
Which half of the heart handles only oxygenated blood?
Left half
Tubes of transport for blood.
Blood vessels
Oxygenated blood is carried in vessels known as:
Arteries
Non-oxygenated blood is carried in vessels known as:
Veins
When blood is traveling away from the heart, it is being carried in a(n):
Artery
When blood is returning to the heart, it is being carried in a(n):
Vein
When un-oxygenated blood travels away from the heart to the lungs is through the:
Pulmonary Vein
When oxygenated blood leaves the lungs and returns to the heart, it’s through the:
Pulmonary Artery
Major Structures of the Cardiovascular System
Blood, blood vessels, heart.
An abnormally low RBC count causing decreased ability of the blood to carry oxygen.
Anemia
Higher or lower than normal pressures in the circulatory system.
Blood Pressure Disorders
Inability of the heart to effectively pump blood to the tissues.
Heart Failure
Electrical disturbance in the conduction of the heart muscle.
Heart Arrhythmias
Disturbance of the blood flow to the heart muscle itself causing chest pain or heart muscle damage.
Myocardial Infarction/Angina
Super-highway that nerves travel to and from the brain.
Central nervous system (CNS)
Structure containing nerve fibers.
Peripheral nervous system (PNS)
A specialized cell that transmits an electrical impulse along its length.
Nerve fiber
Major Structures of the Nervous System
Brain, spinal cord, peripheral nerves.
Damaged caused by trauma.
Injury/accident
Uncontrolled electrical activity in the brain.
Seizure
Movement disorder thought to be caused by a lack of chemical transmitter in the brain.
Parkinson’s disease
Defect in cognitive function of the brain thought to be due to chemical imbalances within the brain.
Psychiatric
Progressive brain disorder that destroys the person’s memory and ability to learn, communicate, and make daily judgments.
Alzheimer’s disease
Condition that occurs when a blood vessel that supplies an area within the brain either clots or bursts and that area of the brain is damaged by lack of blood circulation.
Stroke
Disease in which the protective covering of nerve fibers is destroyed interfering with, or making impossible, nerve impulse transmission.
Multiple Sclerosis
Organ system that provides the body with a mechanism for bringing in oxygen into the body and removing waste gases.
Respiratory system
Gaseous exchange takes place in an organ known as the:
Lungs
Arrange in order the way in which oxygen travels upon entering and exiting the body.
a) Each bronchus splits into smaller bronchial tubes that enter each lung
b) The alveoli (surrounded by circulatory capillaries) absorb oxygen from the lung and give off carbon dioxide
c) Trachea splits into two bronchi, one of which heads to both left and right lungs
d) Each bronchial tube splits into smaller passageways ending in the alveoli
e) Carbon dioxide is exhaled back out through the mouth
f) Enters through nose and mouth and down through trachea
f) Enters through nose and mouth and down through trachea
c) Trachea splits into two bronchi, one of which heads to both left and right lungs
a) Each bronchus splits into smaller bronchial tubes that enter each lung
d) Each bronchial tube splits into smaller passageways ending in the alveoli
b) The alveoli (surrounded by circulatory capillaries) absorb oxygen from the lung and give off carbon dioxide
e) Carbon dioxide is exhaled back out through the mouth
Arrange in order how oxygen travels through the body.
a) Bronchus -> Bronchial Tubes -> Each Lung
b) Mouth/Nose -> Trachea
c) Carbon Dioxide Exhaled -> Mouth/Nose
d) Alveoli -> Absorb Oxygen -> Give Off Carbon Dioxide
e) Bronchial Tubes -> Alveoli
f) Trachea -> 2 Bronchi -> (1) Bronchi -> Each Lung
b) Mouth/Nose -> Trachea
f) Trachea -> 2 Bronchi -> (1) Bronchi -> Each Lung
a) Bronchus -> Bronchial Tubes -> Each Lung
e) Bronchial Tubes -> Alveoli
d) Alveoli -> Absorb Oxygen -> Emit Carbon Dioxide
c) Carbon Dioxide Exhaled -> Mouth/Nose
Chronic Obstructive Pulmonary Disease
COPD
Difficulty in breathing caused by airway constriction, blockage, increased mucous production.
Asthma
Bacterial or viral infection of the lung tissues.
Infection
Particles of inhaled solids that cannot be expelled by the lungs. (Coal dust or asbestos)
Pneumoconiosis
Organ system that removes waste products from the blood stream.
Excretory System
Solutes that crystallize in the collecting ducts
Urinary Stones
Caused by bacterial or viral agents.
Infection
Main filtration organ of the excretory system.
Kidney
Each kidney has their own:
Renal artery and vein
Arrange in order how blood travels through the kidneys.
a) Water/Solutes from Blood -> Bowman’s Capsule
b) Tubules -> Collecting Duct -> Ureter -> Bladder
c) Capillary System -> Wraps Around Nephron
d) Renal Artery -> Kidney
e) Kidney -> Capillary Stage
f) Bowman’s Capsule -> Twisting Tubules of Nephron
d) Renal Artery -> Kidney
e) Kidney -> Capillary Stage
c) Capillary System -> Wraps Around Nephron
a) Water/Solutes -> Bowman’s Capsule
f) Bowman’s Capsule -> Twisting Tubules
b) Tubules -> Collecting Duct -> Ureter -> Bladder
Filtering structure of kidney.
Nephron
Cup shaped structure on the end of each Nephron.
Bowman’s Capsule
Collective intertwining blood vessels formed from ball of capillaries in Bowman’s Capsule.
Glomerulus
Nerves that bring sensory information from the periphery into the CNS or carry nerve impulses to the skeletal muscles.
Somatic
Nerves that carry impulses that regulate smooth muscles of the internal organs and glands.
Autonomic
Nervous system consisting of the brain and spinal cord.
CNS
Nervous system consisting of nerves that lead from the spinal cord and proceed outwardly into body.
PNS
The digesting material is moved either too fast or too slow through the GI tract.
Hyper/Hypo Motility
Swallowed material is discharged back up the esophagus.
Vomitting
Water or loose stools that can be caused by a variety of reasons.
Diarrhea
Too much stomach acid is being produced.
Excess Stomach Acid
Stomach contents and acid are released back into the esophagus.
Gastric Reflux
Areas of stomach tissue that are damaged and no longer have their protected lining intact.
Stomach Ulcers
Enzymes needed for the breakdown of food are absent or insufficient.
Enzyme Deficiencies
Organ system designed for the intake of food, water, and nutrients, the conversion of them to fuel for the body, and the expulsion of left over waste production.
Gastro-Intestinal System
Arrange in order how food travels through the body.
a) Large Intestines -> Anus
b) Small Intestines -> Large Intestines
c) Mouth -> Esophagus
d) Stomach -> Small Intestines
e) Esophagus-> Stomach
c) Mouth -> Esophagus
e) Esophagus-> Stomach
d) Stomach -> Small Intestines
b) Small Intestines -> Large Intestines
a) Large Intestines -> Anus
Where the bulk of nutrient absorption occurs in the body.
Small Intestine
Five foot section of GI Tract dedicated mainly to the reabsorption of water and compaction of remaining material.
Large Intestine
________ __________ serve as a mixing action to aid the process of breaking down food.
Stomach contractions
