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WorksheetsPharmaceutics Exam 1
Total questions: 120
Worksheet time: 1hrs 9mins
Pick a best definition for a drug.
Medication we can only get from a pharmacy that is prescribed by a doctor
Any product that produces a cure in a person
Any product that is approved for use in treating a diagnosis, producing a cure, treatment and/or preventing a disease; and intended to affect the function of the body
A chemical substance a person takes; this may be a drug of wine, a glass of juice or cough sedative
Dosage form is the type of physical product of a drug, mixed with inactive components and active ingredients.
true
false
Select all or any that are possible dosage forms.
tablets
suppositories
solutions
aerosols
What are ways pharmaceutical exicipents work to make a drug more acceptable?
physical appearance
texture of the drug
taste and odor of the drug
cost of the drug
What are the key attributes of pharmaceutical expicients?
safety, quality, functionality
safety, quantity, texture
safety, size, appearance
size, shape, texture
The systematic chemical name is...
the IUPAC
the Brand name
the Generic name
The generic name...
issued only for a single chemical
issued for a single chemical or mixture of chemicals
scientific name
What is the difference between a comatose and ambulatory patient?
ambulatory can not walk and are sitting in the ER waiting for help, very sickly patient
comatose is a patient that is at home going through hospice
comatose is a patient in a state of unconsciousness
ambulatory îs a patient who is able to walk around
Select the reason(s) to why patients need a dosage form.
provides convenience and aesthetics
instant delivery of drugs directly to blood circulation
provides liquid preparation of drugs that are unstable and insoluble for a desire solvent
provide time or site-specific action
Drug delivery systems are specialized dosage forms with specific...
release rate and release site
action site
receptor site and release rate
Which dosage form characteristic affect bioavailability of drug?
disintegration/ dissolution rate
solid-state form
storage conditions
particle size
What physiologic factors and patient characteristic affect bioavailability of a drug?
drug metabolism
gastric emptying time/ intestinal timing
fluids in system
gastrointestinal pH
drugs effects, food, fed or fasting status
Select advantage(s) of oral RoA.
wide range of pH availability for absorption through GI tract
convenient
non-invasive
most natural compared to other routes
Select the classification(s) of drug forms.
physical state
intended action
route
duration
Which classification of dosage forms is that of physical state?
solid, semi-solid, liquids, disperse systems
system and local
enteral and paternal
fast acting and long acting
Which classification(s) of dosage forms is that of intended action?
solid, semi-solid, liquids, disperse system
systemic and local
enteral and paternal
fast acting and long acting
Which classification of dosage forms are that of RoA?
solids and semi-solids
systemic and local
enteral and paternal
fast acting and long acting
Which classification of dosage forms is related to duration of action?
fast acting and long acting
enteral and parenteral
system and local
solid, semi-sold, liquids, and disperse systems
Select enteral route(s).
oral, rectal, sublingual
oral, rectal, nasal
nasal, otic, ocular
pulmonary, oral, rectal
What is the difference between enteral RoA and parenteral RoA?
enteral RoA the medication flows through the intestine before getting to the intended site
parenteral RoA the medication avoids the intestinal route
enteral RoA and parenteral RoA flow opposite routes and are excreted untimely
parental RoA flows through the intestinal tract and enteral RoA flow past the intestinal RoA
Drugs work by:
Having active ingredients (API) in a dosage form, RoA, absorption of drug into circulation, then reaching drug target.
True
False
Bioavailability is the rate and extent to which a drug is absorbed from a dosage form and become available at the site of action.
True
False
What flow will oral administration take?
mouth, GI tract, circulatory system, target, excreted
GI tract, circulatory system, target, excreted
mouth, GI tract, target, excreted
mouth, GI tract, circulatory system, excreted
The acting of a drug, fast or long, is the process of which classification of dosage forms?
physical state
duration of action
intended action
route of administration
Drugs act systemically or locally, which classification of dosage forms is this?
intended action
duration of action
route of administration
physical state
Which oral dosage form has the highest bioavailability?
solution
coated tablets
suspension
capsule
Which oral dosage form has the lowest bioavailability?
solution
coated tablets
uncoated tablets
capsules
True or False.
Variety of dosage forms can be designed for enteral and parenteral routes of administration.
True
False
The route of IV injections:
Injected into the circulatory system
From the circulatory system can be distributed to GI tract and tissue
Drug reach intended site
Drug metabolizes and excreted
IM and SC injection route:
Injected into the tissues
Distributes to the circulatory system and GI tract
Drug metabolize and excreted
Into tissues, metabolite, excreted
Which correctly defines bioavailable dose?
The rate and extent to which a drug substance is absorbed from a drug product (a dosage form) and becomes available at the site of drug action
The fraction of an administered dose that reaches the systemic circulation in the unchanged form
The ability of a drug to reach the systemic circulation and also be distributed to tissues and GI tract
The absorption from a drug product (a dosage form) and becomes available at the site of drug action
Metabolism is also called...
biotransformation
detoxification
inactivation
biomolecules
Metabolism involves...
the chemical changes to drugs within the body
the physical changes to drugs within the body
the overall mechanism of drugs within the body
First pass effect means
drug is only metbolized in liver
drug is only metabolize in gut
drug is may metabolize in liver and Gi
drug makes a pass and goes into the circulation
Non-first pass means
drug does not metabolize in liver
drug makes its way to site
bioavailability is variable
Can drugs be reabsorbed?
Yes
No
Define adult dose.
is the amount of drug that usually produces the medicinal effect in the adult patient
is the amount that that usually produces the medicinal effect in the infant or child patient
is a dose given at the beginning of treatment to start getting the effect of a drug
is the amount that that usually produces the medicinal effect in any patient
Define pediatric dose.
is the amount of drug that usually produces the medicinal effect in the adult patient
is the amount that that usually produces the medicinal effect in the infant or child patient
is the amount that that usually produces the medicinal effect in any patient
Define dosage regimen.
is the prescribed schedule of dosing
is a larger-than-usual initial dose
are similar in amount to usual doses and are used to sustain the desired drug blood levels
is a dose given at the beginning of treatment to start getting the effect of a drug
Define initial dose.
is a dose given at the beginning of treatment to start getting the effect of a drug
larger than usual dose
the lowest concentration dose
the amount the produces intensity
Define loading dose.
is a dose given at the beginning of treatment to start getting the effect of a drug
a larger than usual initial dose
the prescribed schedule of dosing
Is the ratio (TD50/ED50) between a drug's median toxic dose & its median effective dose -
therapeutic dose
median toxic dose (TD)
median effective dose (ED)
minimum toxic concentration (MTC)
Is the amount that produces toxic effects in 5o% of the people -
median toxic dose (TD)
median effective dose (ED)
therapeutic index
minimum effective concentration (MEC)
Which defines minimum toxic concentration (MTC)?
is the minimum serum concentration of the drug that can produce the desired therapeutic effect
is the lowest concentration of an antimicrobial drug that prevents visible growth of a microorganism after incubation with media.
is the base level of blood serum concentration that produces dose-related toxic effects
is the amount that produces toxic effects in 50% of the individuals
Define maintenance dose.
are similar in amount to usual doses and are used to sustain the desired drug blood levels
is a larger-than-usual initial dose
is a dose given at the beginning of treatment to start getting the effect of a drug
is the lowest concentration of an antimicrobial drug that prevents visible growth of a microorganism after incubation with media.
Is the base level of blood serum concentration that produces dose related toxic efects -
minimum toxic concentration (MTC)
median effect dose (ED)
median toxic dose (TD)
minimum inhibitory concentration (MIC)
What are sources for new drugs?
plants
synthesized in labs
biotechnology
universities
What are the benefits from drugs being synthesized in labs?
having high purity
less expensive
more expensive
large production
How are drugs discovered?
by a medical staff
from a disease
from signs/symptoms
based on the receptor type
from historians
Select which definition is a goal drug.
to find an active ingredients or modify an existing active ingredients
prototype of the drug that has desire activity but also many undesirable characteristics
compound that is worthy of extensive biological, pharmacological, and animal testing
is required to have a metabolic transformation after administration to produce desire effect of active compound
Select the definition of lead compound.
is a prototype of the drug that has desire activity but also many undesirable characteristics
to find an active ingredient or modify an existing active ingredient to form a new drug
is a compound that is worthy of extensive biological, pharmacological, and animal testing
is required to have a metabolic transformation after administration to produce desire effect of active compound
Which is a great definition of drug candidate?
is required to have a metabolic transformation after administration to produce desire effect of active compound
is a compound that is worthy of extensive biological, pharmacological, and animal testing
is a prototype of the drug that has desire activity but also many undesirable characteristics
to find an active ingredient or modify an existing active ingredient to form a new drug
Define a prodrug.
to find an active ingredient or modify an existing active ingredient to form a new drug
is required to have a metabolic transformation after administration to produce desire effect of active compound
is a compound that is worthy of extensive biological, pharmacological, and animal testing
is a prototype of the drug that has desire activity but also many undesirable characteristics
Which is the most desirable RoA?
oral
IV injection
rectal
topical
Select any lead discovery methods.
random screening
metabolism studies
clinical observation
rational design
high throughput screening
Which lead discovery method identifies the cause of the disease and used that a the substrate or known drug?
rational design
clinical observation
metabolism studies
high throughput screening
Which lead discovery method is used to screen for same or other potential activities?
metabolism studies
clinical observation
rational design
random screening
Scientist bring together tractable targets and chemical to identify the lead compound
HTS
rational drug
clinical observation
metabolism studies
What does the lead optimization process result in?
drug
drug candidate
approved drug
lead compound
The lead optimization process
test the activity
test the potency
test the activity and potency
IC50 is the concentration at 50% of the drug will inhibit
true
false
EC50 is the 50% concentration to produce effectiness.
True
False
Which is the definition fo activity of a drug?
biological effect produced
is the strength of the biological effect produced
neither
both
Which is the best definition of potency of a drug?
biological effect produced
strength of biological effect produced
both
neither
Which is Phase 1 of clinical trials?
testing in humans for the first time, asses the risk vs the benefits, determine the metabolic activity along with side effects
evaluates pharmacological effects and test the efficacy of the drug, identifies the dosage and response characteristics of drug
evaluates the overall benefit-risk relationship which proves information of efficacy and safety of drug
continual data collecting, where long-term effects are discovered, product defects are reported and determined
How many phases are clinical trials split into?
one
two
three
none
The preclinical studies test in humans.
False
True
Phase 2 clinical trials..
testing in humans for the first time, asses the risk vs the benefits, determine the metabolic activity along with side effects
evaluates the overall benefit-risk relationship which proves information of efficacy and safety of drug
evaluates pharmacological effects and test the efficacy of the drug, identifies the dosage and response characteristics of drug
continual data collecting, where long-term effects are discovered, product defects are reported and determined
Which event partake in Phase 3 of clinical trials?
continual data collecting, where long-term effects are discovered, product defects are reported and determined
evaluates the overall benefit-risk relationship which proves information of efficacy and safety of drug
evaluates pharmacological effects and test the efficacy of the drug, identifies the dosage and response characteristics of drug
testing in humans for the first time, asses the risk vs the benefits, determine the metabolic activity along with side effects
In new drug development process.
This is the are part of the drug discovery stage where chemistry, physical properties and biologic activity are assessed of a potential lead compound as safe and effective therapeutical.
preclinical studies
clinical trials
phase 1
post marketing
This phase is checking the safety in humans.
phase 1
phase 2
phase 3
phase 4
This phase test the effectiveness of the drug.
phase 1
phase 2
phase 3
phase 4
This phase checks for the safety, effectiveness and dosage.
phase 1
phase 2
phase 3
phase 4
This phase determines the metabolic activity and side effects of a dose.
phase 1
phase 2
phase 3
phase 4
This phase evaluates test the ability to produce the desire effect of the drug, the efficacy.
phase 1
phase 2
phase 3
phase 4
This phase evaluates the overall benefit to risk of the drug.
phase 2
phase 3
phase 1
none
When will IND be submitted in drug approval process.
before clinical trials
after clinical trials
after NDA
after postmarking
When will NDA be submitted in the drug approval process?
before postmarking, after clinical trials
after clinical trial, before preclinical trials
after preclinical trials, before IND
after IND and after clinical trials
The name of IND.
Investigation New Drug Application
New Drug Application
Abbreviated New Drug Application
Biologic License Application
The name of NDA.
New Drug Application
Investigational New Drug Application
Abbreviated New Drug Application
Biologic License Application
Which drug application is used to gain approval for generic drugs.
NADA
NDA
ANDA
IND
This drug application is required for biologic, vaccines and human blood products.
BLA
ANDA
NDA
IND
This application seeks approval to market a new product after preclinical and clinical studies are completed.
NDA
IND
ANDA
BLA
This application must be submitted for a new drug to begin testing in humans.
NDA
IND
ANDA
BLA
Which application matches the goal to protect the right and safety of human and to ensure the investigation is coherent and sound.
NDA
IND
ANDA
BLA
Which application goal is to gain marketing permission of a new drug?
IND
NDA
ANDA
BLA
This application establishing bioequivalence of generic and original drug.
ANDA
NDA
IND
BLA
No preclinical or clinical study necessary for this application.
ANDA
NDA
IND
BLA
When is a clinical hold place on a IND application of a drug?
unreasonable risk are show
unqualified investigators are reviewed
misleading information from investigators
not enough information is established
What is the process for an orphan drug?
to be used for a rare condition
can be submitted at anytime
only able to submit after trials are completed
other sources have failed
A full hold is placed on a new drug when all clinical studies must be resolved.
True
False
(a) is to find an active ingredient or modify existing active ingredient to form a new drug
Best definition of prodrug.
a compound that requires metabolic transformation after it is administrated to produce desire pharmacologically active compound
an active drug
do not need to metabolize because they are prodrug, so produce an desire effect
Select the rationale for preformulation studies.
the process is doing before learning
the process of completely a new drug and putting the shelf
the process of investigating properties ingredients before forming the drug
Select the goals of preformulation
to establish physical characteristics
to establish necessary parameters
to establish the compatibility
to determine the stability
all are correct
What is the principle of thermal analysis?
the change in thermal energy as a function of temperature
the change in all properties of a drug
to purpose a melting form of a drug
Thermal analysis is studying the properties of material as they change with temperature.
True
False
Differential Scanning Calorimetry (DSC) is the difference of heat required to increase temperature of a sample.
true
false
When a molecules melts -
endothermic
exothermic
moves in a positive (upward) direction
moves in a negative (downward) direction
When a molecule crystallizes -
it's endothermic
it's exothermic
its moves in a positive direction
moves in a negative direction
What does (TGA) Thermogravimetric Analysis?
tells the loss/gain of weight of compound when the temperature change
measures the changes of properties of product
measure the temperature changes of compound based on loss/gain of weight
(TMA) Thermomechanical Analysis measures
the change of dimensions/ mechanical properties of a sample against the temperature
measure changes without any temperature acting on it
measures the loss/gain of weight due to temperature
The purer the compound, the (a) the MP range
The purer the compound, the (a) the MP.
How is melting point (MP) affecting the compound?
the purity of the compound
the product of the compound
the weight of the compound
the dimension of the compound
When a compound has many impurities -
the MP low
the MP range is very broad
the MP is high
has a very small MP range
What is polymorphism?
the ability of a solid to exist in multiple forms or crystal structure
the existing of multiple forms
the disappearance of a product as it vaporizes
ability of a product to vaporizes and reappear as a solid
A crystal solid has:
fixed internal structure
is less soluble
does not tend to change form
none of these
A molecule without a clearly define shape is -
amorphous
crystalline
neither
both
An amorphous solid -
no fixed internal structure
higher solubility
reverts to stable when stored
lower solubility
Which is the definition for enantiotrophs?
one form stable over certain pressure or temperature; while the other is stable over a different pressure and temp range
one form is stable over all temperatures below MP, while other forms are unstable
Best definition for monotrophs.
one form is stable over all temperatures below MP, while other forms are unstable
one form stable over certain pressure or temperature; while the other is stable over a different pressure and temp range
Which is reversible?
enantiotropic
monotropic
Select the correct match
enantiotropic/endothermic
monotropic/endothermic
enantiotropic/exothermic
monotropic/exothermic
Has a higher MP, lower heat of fusion
enantiotropic
monotropic
These dosage form characteristic affect the bioavailability of a drug
solid-state form
disintegration/dissolution rate
storage conditions
particle size
Type of dosage forms of parenteral injection RoA.
aerosol
sterile solution
ointments
suspensions
What are the disadvantages of transdermal RoA?
expensive
low molecular weight with high partition coefficient are suitable for transdermal formulations
controlled delivery of drugs
having high molecular weight with low solubility to bypass skin layer
Some factors effecting bioavailability.
physiochemical properties of drug
dosage form characteristics
pharmaceutical excipients
physiological factors and patient characteristics
What are advantages of transdermal RoA?
convenient
can be removed
escapes first pass effect
controlled delivery of drugs
