BCMAS Exam Questions and answers with complete solutions Latest Updated
2025 | Verified
Abbreviated New Drug Application - 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) - Raw chemical materials that are used to manufacture drugs
Adjuvant Therapy - Additional treatment to the main or initial treatment that is designed to maximize its
effectiveness
Adulteration - Refers to pharmaceutical products that fail to meet health or safety standards as
determined by FDA.
alternative hypothesis - Also known as research hypothesis - hypothetical testing assuming that there is
difference between the groups/outcomes of interest.
Bias - 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 - 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 - 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 - Biologic license application: Application to be submitted for FDA approval of biosimilar products
Biologics - 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 - Characteristics that are objectively measured and evaluated as an indicator of normal
biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.
Biosimilars - 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 - 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 - 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 - Type of retrospective study where the selection of participants is based on the
outcome and then looks backwards to determine possible exposures
CDER - 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 - Diseases that last three months or more
CMS - Center for medicare and medicaid services - Federal agency within the US HHS (Human and
Health services)
Cohort study - 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 - 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 - A device that can be used for some particular purposes
Cost-benefit analysis - 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 - Method used to measure costs in monetary value and outcomes in natural
health units (such as cholesterol level, blood pressure).
Cost-minimization analysis - Method used to measure cost in monetary value, assuming outcomes to be
equivalent
Cost-utility analysis - 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.
Cross-sectional study - Survey or prevalence study
CTD - Common technical document - a set of specification for application on dossier for drug registration
and for submission to regulatory authorities
Descriptive statistics - Refers to the collection, presentation and description of data on populations and
samples, which represents group's characteristics.
Direct clinical endpoint - Clinically meaningful endpoint that directly measures how a patient feels,
functions or survives. Examples include survival rate, disease exacerbation, and symptom score.
2025 | Verified
Abbreviated New Drug Application - 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) - Raw chemical materials that are used to manufacture drugs
Adjuvant Therapy - Additional treatment to the main or initial treatment that is designed to maximize its
effectiveness
Adulteration - Refers to pharmaceutical products that fail to meet health or safety standards as
determined by FDA.
alternative hypothesis - Also known as research hypothesis - hypothetical testing assuming that there is
difference between the groups/outcomes of interest.
Bias - 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 - 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 - 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 - Biologic license application: Application to be submitted for FDA approval of biosimilar products
Biologics - 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 - Characteristics that are objectively measured and evaluated as an indicator of normal
biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.
Biosimilars - 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 - 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 - 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 - Type of retrospective study where the selection of participants is based on the
outcome and then looks backwards to determine possible exposures
CDER - 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 - Diseases that last three months or more
CMS - Center for medicare and medicaid services - Federal agency within the US HHS (Human and
Health services)
Cohort study - 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 - 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 - A device that can be used for some particular purposes
Cost-benefit analysis - 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 - Method used to measure costs in monetary value and outcomes in natural
health units (such as cholesterol level, blood pressure).
Cost-minimization analysis - Method used to measure cost in monetary value, assuming outcomes to be
equivalent
Cost-utility analysis - 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.
Cross-sectional study - Survey or prevalence study
CTD - Common technical document - a set of specification for application on dossier for drug registration
and for submission to regulatory authorities
Descriptive statistics - Refers to the collection, presentation and description of data on populations and
samples, which represents group's characteristics.
Direct clinical endpoint - Clinically meaningful endpoint that directly measures how a patient feels,
functions or survives. Examples include survival rate, disease exacerbation, and symptom score.
