BPS 2110 Final Exam Questions And 100% Correct Answers
Drug definition - ANSWER chemical substance used in treatment, prevention, diagnosis
Chemical substance used to enhance quality of life
Drug types - ANSWER biological
small molecule
biological drug - ANSWER vaccine, protein, antibody, nucleic acid
molecular weight >2000
made of living things
small molecule drugs - ANSWER molecular weight <2000
made of living things and chemical synthesis
pharmaceutical industry - ANSWER multi billion dollar industry
highly regulated
research intensive
high risk and profit
Ethical Pharmaceutical Companies - ANSWER heavily invest in research
discover and develop new molecular entities
large 100,000 employees
generic pharmaceutical companies - ANSWER limited research
focus on breaking/adapting patents
manufacturing methods and formulation
medium to large 100,000 employees
biotech companies - ANSWER exploit academic discoveries
,research intensive
small 10-1000 employees
few specialty products
often bought by large companies
Contract Research Organization CRO - ANSWER specialty services:
biological testing
specialty chemical synthesis
specialty manufacturing
clinical trials
small to medium 100-10,000 employees
Drug Product Database ANSWER database that contains information on over 47 000
products
Compendium of Pharmaceuticals and Specialties ANSWER information on > 2000
molecular entities
molecular entity ANSWER pure ingredient
EXAMPLE: acetaminophen
Drug Product ANSWER material that contains the molecular entity
EXAMPLE: Tylenol
typical timeline of a project ANSWER 1. idea or discovery
2. project initiation and feasibility study
3. discovery
,4. development
5. clinal trials
6. market
timeline of events for molecular entity ANSWER 1. discovery
- 1-3 years
- Drug candidate identified
2. Development
- 1-2 years
- IND-Investigational new drug
3. Clinical trials
- 1-5 years
- NDA-New Drug application
4. FDA approval
- 6 m -1.5 years
5. Market
Drug Candidate - ANSWER compound worthy of extensive biological, pharmacological,
and animal testing
Investigational New Drug (IND) - ANSWER A drug not yet approved for marketing by the
FDA but available for use in experiments to determine its safety and efficacy.
when applying for IND include :
, Animal Pharmacology and Toxicity Data
Manufacturing Information
Clinical Protocols and Investigator Information
New Drug Application (NDA) - ANSWER If adequate data are available to demonstrate
that a drug is safe and effective, a company submits an NDA as a formal request that the
FDA approve the drug for marketing.
When Applying for NDA - include:
Appropriate Labeling
Manufacturing Methods
Abbreviated New Drug Application (ANDA) - ANSWER Different company submits to
market generic drug after innovator company patent expires. New drug requires proof
of similar pharmacokinetic properties, bioavailability, clinical activity.
Discovery: Project Initiation - ANSWER drug companies target the market not the
disease
perform market analysis, competitive assessment, research analysis
Discovery: Market analysis - ANSWER number of potential customers
type of potential costumers
nature of disease: chronic vs acute
current treatment: is the current treatment convenient?
discovery: feasibility study - ANSWER focus on solvable problem: is the disease well
understood, is the mechanism of disease understood.
Are there biochemical tools available?
Are there existing drugs?
timing into market - ANSWER 1st drug: $$
Drug definition - ANSWER chemical substance used in treatment, prevention, diagnosis
Chemical substance used to enhance quality of life
Drug types - ANSWER biological
small molecule
biological drug - ANSWER vaccine, protein, antibody, nucleic acid
molecular weight >2000
made of living things
small molecule drugs - ANSWER molecular weight <2000
made of living things and chemical synthesis
pharmaceutical industry - ANSWER multi billion dollar industry
highly regulated
research intensive
high risk and profit
Ethical Pharmaceutical Companies - ANSWER heavily invest in research
discover and develop new molecular entities
large 100,000 employees
generic pharmaceutical companies - ANSWER limited research
focus on breaking/adapting patents
manufacturing methods and formulation
medium to large 100,000 employees
biotech companies - ANSWER exploit academic discoveries
,research intensive
small 10-1000 employees
few specialty products
often bought by large companies
Contract Research Organization CRO - ANSWER specialty services:
biological testing
specialty chemical synthesis
specialty manufacturing
clinical trials
small to medium 100-10,000 employees
Drug Product Database ANSWER database that contains information on over 47 000
products
Compendium of Pharmaceuticals and Specialties ANSWER information on > 2000
molecular entities
molecular entity ANSWER pure ingredient
EXAMPLE: acetaminophen
Drug Product ANSWER material that contains the molecular entity
EXAMPLE: Tylenol
typical timeline of a project ANSWER 1. idea or discovery
2. project initiation and feasibility study
3. discovery
,4. development
5. clinal trials
6. market
timeline of events for molecular entity ANSWER 1. discovery
- 1-3 years
- Drug candidate identified
2. Development
- 1-2 years
- IND-Investigational new drug
3. Clinical trials
- 1-5 years
- NDA-New Drug application
4. FDA approval
- 6 m -1.5 years
5. Market
Drug Candidate - ANSWER compound worthy of extensive biological, pharmacological,
and animal testing
Investigational New Drug (IND) - ANSWER A drug not yet approved for marketing by the
FDA but available for use in experiments to determine its safety and efficacy.
when applying for IND include :
, Animal Pharmacology and Toxicity Data
Manufacturing Information
Clinical Protocols and Investigator Information
New Drug Application (NDA) - ANSWER If adequate data are available to demonstrate
that a drug is safe and effective, a company submits an NDA as a formal request that the
FDA approve the drug for marketing.
When Applying for NDA - include:
Appropriate Labeling
Manufacturing Methods
Abbreviated New Drug Application (ANDA) - ANSWER Different company submits to
market generic drug after innovator company patent expires. New drug requires proof
of similar pharmacokinetic properties, bioavailability, clinical activity.
Discovery: Project Initiation - ANSWER drug companies target the market not the
disease
perform market analysis, competitive assessment, research analysis
Discovery: Market analysis - ANSWER number of potential customers
type of potential costumers
nature of disease: chronic vs acute
current treatment: is the current treatment convenient?
discovery: feasibility study - ANSWER focus on solvable problem: is the disease well
understood, is the mechanism of disease understood.
Are there biochemical tools available?
Are there existing drugs?
timing into market - ANSWER 1st drug: $$
