BCMAS TERMS STUDY GUIDE
Abbreviated New Drug Application - Answer -Application to be submitted for FDA
approval of generic drugs, where data about bioequivalence or therapeutic equivalence
must be clearly demonstrated. Companies are allowed to submit ANDA once the
patents of bioequivalent brand-name drugs have expired.
Active Pharmaceutical Ingredients (API's) - Answer -Raw chemical materials that are
used to manufacture drugs
Adjuvant Therapy - Answer -Additional treatment to the main or initial treatment that is
designed to maximize its effectiveness
Adulteration - Answer -Refers to pharmaceutical products that fail to meet health or
safety standards as determined by FDA.
alternative hypothesis - Answer -Also known as research hypothesis - hypothetical
testing assuming that there is difference between the groups/outcomes of interest.
Bias - Answer -Systematic error in sampling and measurement that leads to an
incorrect conclusion. Bias commonly occurs while conducting a clinical trial and is
usually during selection/enrollment of a study participants and measurement of
exposure/outcome.
Biocompatibility - Answer -The properties of materials being compatible with living
tissue or a living system, by not being toxic, injurious, or not eliciting local or systemic
responses from a living system or tissue.
Bioequivalence - Answer -The property wherein two drugs with identical active
ingredients or two different dosage forms of the same drug possess similar
bioavailability and produce the same effect at the site of physiological activity
BLA - Answer -Biologic license application: Application to be submitted for FDA
approval of biosimilar products
Biologics - Answer -Biological products such as vaccines, blood and blood
components, allergenics, somatic cells, gene therapy, tissues and recombinant
therapeutic proteins. They are isolated from natural sources. Gene-based and cellular
biologics often are at forefront of biomedical research, and may be used to treat a
variety of complicated or rare diseases.
Biomarkers - Answer -Characteristics that are objectively measured and evaluated as
an indicator of normal biological processes, pathogenic processes, or pharmacologic
responses to a therapeutic intervention.
, Biosimilars - Answer -Biological products that are approved based on showing that they
are highly similar to already FDA-approved biological products and have been shown to
have no clinically meaningful differences from the already approved biological products.
Case report - Answer -Type of clinical study that analyzes a group of people with single
exposure or outcome. Exposure can be a disease, a risk factor or an intervention.
Case series - Answer -Type of clinical study that analyzes a group of people with single
exposure or outcome. Exposure can be a disease, a risk factor or an intervention.
Case control study - Answer -Type of retrospective study where the selection of
participants is based on the outcome and then looks backwards to determine possible
exposures
CDER - Answer -Center for drug evaluation and research - a department within FDA
that performs an essential public health task by making sure that safe and effective
drugs are available to improve the health of people in the United States.
chronic diseases - Answer -Diseases that last three months or more
CMS - Answer -Center for medicare and medicaid services - Federal agency within the
US HHS (Human and Health services)
Cohort study - Answer -Type of clinical study that is designed to follow a group of
people and then look at how events differ among people within the group. Prospective
and retrospective
Composite clinical endpoint - Answer -A single measure of effect, based on a
combination of individual endpoints. This type of endpoint is particularly useful for drugs
that can benefit patients in several ways or if component events are infrequent.
Contrivance - Answer -A device that can be used for some particular purposes
Cost-benefit analysis - Answer -Method used to measure inputs and outcomes in
monetary value. Cost-benefit analysis is often performed to determine how institutions
can best spend their resources to produce monetary benefits.
Cost-effectiveness analysis - Answer -Method used to measure costs in monetary
value and outcomes in natural health units (such as cholesterol level, blood pressure).
Cost-minimization analysis - Answer -Method used to measure cost in monetary value,
assuming outcomes to be equivalent
Cost-utility analysis - Answer -Method used to measure the health outcomes in terms of
the number of years lived in full health by the beneficiaries. The unit of measurement is
not monetary terms but is expressed in quality-adjusted life years.
Abbreviated New Drug Application - Answer -Application to be submitted for FDA
approval of generic drugs, where data about bioequivalence or therapeutic equivalence
must be clearly demonstrated. Companies are allowed to submit ANDA once the
patents of bioequivalent brand-name drugs have expired.
Active Pharmaceutical Ingredients (API's) - Answer -Raw chemical materials that are
used to manufacture drugs
Adjuvant Therapy - Answer -Additional treatment to the main or initial treatment that is
designed to maximize its effectiveness
Adulteration - Answer -Refers to pharmaceutical products that fail to meet health or
safety standards as determined by FDA.
alternative hypothesis - Answer -Also known as research hypothesis - hypothetical
testing assuming that there is difference between the groups/outcomes of interest.
Bias - Answer -Systematic error in sampling and measurement that leads to an
incorrect conclusion. Bias commonly occurs while conducting a clinical trial and is
usually during selection/enrollment of a study participants and measurement of
exposure/outcome.
Biocompatibility - Answer -The properties of materials being compatible with living
tissue or a living system, by not being toxic, injurious, or not eliciting local or systemic
responses from a living system or tissue.
Bioequivalence - Answer -The property wherein two drugs with identical active
ingredients or two different dosage forms of the same drug possess similar
bioavailability and produce the same effect at the site of physiological activity
BLA - Answer -Biologic license application: Application to be submitted for FDA
approval of biosimilar products
Biologics - Answer -Biological products such as vaccines, blood and blood
components, allergenics, somatic cells, gene therapy, tissues and recombinant
therapeutic proteins. They are isolated from natural sources. Gene-based and cellular
biologics often are at forefront of biomedical research, and may be used to treat a
variety of complicated or rare diseases.
Biomarkers - Answer -Characteristics that are objectively measured and evaluated as
an indicator of normal biological processes, pathogenic processes, or pharmacologic
responses to a therapeutic intervention.
, Biosimilars - Answer -Biological products that are approved based on showing that they
are highly similar to already FDA-approved biological products and have been shown to
have no clinically meaningful differences from the already approved biological products.
Case report - Answer -Type of clinical study that analyzes a group of people with single
exposure or outcome. Exposure can be a disease, a risk factor or an intervention.
Case series - Answer -Type of clinical study that analyzes a group of people with single
exposure or outcome. Exposure can be a disease, a risk factor or an intervention.
Case control study - Answer -Type of retrospective study where the selection of
participants is based on the outcome and then looks backwards to determine possible
exposures
CDER - Answer -Center for drug evaluation and research - a department within FDA
that performs an essential public health task by making sure that safe and effective
drugs are available to improve the health of people in the United States.
chronic diseases - Answer -Diseases that last three months or more
CMS - Answer -Center for medicare and medicaid services - Federal agency within the
US HHS (Human and Health services)
Cohort study - Answer -Type of clinical study that is designed to follow a group of
people and then look at how events differ among people within the group. Prospective
and retrospective
Composite clinical endpoint - Answer -A single measure of effect, based on a
combination of individual endpoints. This type of endpoint is particularly useful for drugs
that can benefit patients in several ways or if component events are infrequent.
Contrivance - Answer -A device that can be used for some particular purposes
Cost-benefit analysis - Answer -Method used to measure inputs and outcomes in
monetary value. Cost-benefit analysis is often performed to determine how institutions
can best spend their resources to produce monetary benefits.
Cost-effectiveness analysis - Answer -Method used to measure costs in monetary
value and outcomes in natural health units (such as cholesterol level, blood pressure).
Cost-minimization analysis - Answer -Method used to measure cost in monetary value,
assuming outcomes to be equivalent
Cost-utility analysis - Answer -Method used to measure the health outcomes in terms of
the number of years lived in full health by the beneficiaries. The unit of measurement is
not monetary terms but is expressed in quality-adjusted life years.
