PHARMACEUTICS EXAM 1 WITH ACTUAL
QUESTIONS AND CORRECT ANSWERS LATEST
UPDATE
What are the general classifications of drug products?
solids, liquids, semisolids, and miscellaneous
What are the requirements of a drug product?
1. the drug and excipients should be compatible
2. the product should be manufactured under appropriate measurements
of QC
3. The product should be packaged in containers that contribute to
product stability
4. The product should be labeled for correct use and to be stored under
conditions that contribute to maximum shelf life
What is important to remember about drug substances?
They are rarely administered alone, but as a part of a formulation in
combination with one or more non-medicinal agent
What does DF stand for?
dosage form
What is pharmaceutics broadly concerned with?
The formulation, manufacture, stability, and effectiveness of
pharmaceutical DFs
What is a drug substance?
An active pharmaceutical ingredient intended to furnish pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment,
or prevention of disease or to affect the structure or any function of the
human body
What is a drug product?
,finished dosage form, that either contains or does not contain an active
ingredient in association with inactive ingredients for clinical use or as a
placebo, respectively
What is an excipient?
Any substance other than the active drug or product that are included in
a drug delivery system that aid in processing during manufacturing,
protect, support or enhance stability, bioavailability or patient
acceptability, or enhance other attributes of overall safety and
effectiveness
What is a medical device?
An instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including a component
part which is: recognized and intended for use/to affect
What is dosage form?
The physical manifestation of a drug as a solid, liquid, or gas that can be
used in a particular way
What can delivery system mean?
1. design feature of the dosage form that affects the delivery of the drug
2. means for transporting a drug to its site(s) of action within the body
3. could be a device used to deliver the drug
How can delivery systems differ in pharmacological properties?
They can differ in sites of action, rate of delivery, and quantities of active
ingredient delivered
What are some considerations for the choice of proper dosage forms?
therapeutic factors (nature of illness and the manner of treatment),
patient age, material properties of the drug
What is another name for brand name?
Proprietary name
What is another name for generic name?
, Non-proprietary name
Who establishes standardized nomenclature of drugs?
The United States Adopted Names Council and WHO
What is important to remember about generic products in regards to
brand products?
Generic products must be pharmaceutically equivalent to the brand
product as well as being bioequivalent
Pharmaceutical equivalent (PE)
The products should contain the same drug in the same amount, in the
same dosage form, for the same route of administration
Bioequivalent (BE)
The rate and extent of drug absorption is similar
What does it mean for a drug to have therapeutic equivalence?
It must be PE and BE
What requirements for Brand Name Drug NDA's are there?
1. chemistry
2. manufacturing
3. controls
4. labeling
5. testing
6. animal studies
7. clinical studies
8. bioavailability
What requirements for Generic Drug ANDA's are there?
1. chemistry
2. manufacturing
3. controls
4. labeling
QUESTIONS AND CORRECT ANSWERS LATEST
UPDATE
What are the general classifications of drug products?
solids, liquids, semisolids, and miscellaneous
What are the requirements of a drug product?
1. the drug and excipients should be compatible
2. the product should be manufactured under appropriate measurements
of QC
3. The product should be packaged in containers that contribute to
product stability
4. The product should be labeled for correct use and to be stored under
conditions that contribute to maximum shelf life
What is important to remember about drug substances?
They are rarely administered alone, but as a part of a formulation in
combination with one or more non-medicinal agent
What does DF stand for?
dosage form
What is pharmaceutics broadly concerned with?
The formulation, manufacture, stability, and effectiveness of
pharmaceutical DFs
What is a drug substance?
An active pharmaceutical ingredient intended to furnish pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment,
or prevention of disease or to affect the structure or any function of the
human body
What is a drug product?
,finished dosage form, that either contains or does not contain an active
ingredient in association with inactive ingredients for clinical use or as a
placebo, respectively
What is an excipient?
Any substance other than the active drug or product that are included in
a drug delivery system that aid in processing during manufacturing,
protect, support or enhance stability, bioavailability or patient
acceptability, or enhance other attributes of overall safety and
effectiveness
What is a medical device?
An instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including a component
part which is: recognized and intended for use/to affect
What is dosage form?
The physical manifestation of a drug as a solid, liquid, or gas that can be
used in a particular way
What can delivery system mean?
1. design feature of the dosage form that affects the delivery of the drug
2. means for transporting a drug to its site(s) of action within the body
3. could be a device used to deliver the drug
How can delivery systems differ in pharmacological properties?
They can differ in sites of action, rate of delivery, and quantities of active
ingredient delivered
What are some considerations for the choice of proper dosage forms?
therapeutic factors (nature of illness and the manner of treatment),
patient age, material properties of the drug
What is another name for brand name?
Proprietary name
What is another name for generic name?
, Non-proprietary name
Who establishes standardized nomenclature of drugs?
The United States Adopted Names Council and WHO
What is important to remember about generic products in regards to
brand products?
Generic products must be pharmaceutically equivalent to the brand
product as well as being bioequivalent
Pharmaceutical equivalent (PE)
The products should contain the same drug in the same amount, in the
same dosage form, for the same route of administration
Bioequivalent (BE)
The rate and extent of drug absorption is similar
What does it mean for a drug to have therapeutic equivalence?
It must be PE and BE
What requirements for Brand Name Drug NDA's are there?
1. chemistry
2. manufacturing
3. controls
4. labeling
5. testing
6. animal studies
7. clinical studies
8. bioavailability
What requirements for Generic Drug ANDA's are there?
1. chemistry
2. manufacturing
3. controls
4. labeling
