BPS 2110 EXAM QUESTIONS AND CORRECT ANSWERS
Drugs Definition
Chemical substances used for the treatment, prevention or diagnosis of disease and
have been shown to enhance quality of life
Name the two types of Drugs
Biologics
Small Molecules
Biologics and examples
- Made using living organisms (plants, animals.)
- High molecular weight (>2000)
-examples: vaccines, antibodies
Small molecules and examples
- Made through chemical synthesis
- Low molecular weight (<2000)
-examples: steroid, antibiotics
The pharmaceutical industry characteristics
- Highly regulated (long process to be FDA approved)
- Research intense
- High risk of failure but also high profit if successful
,Define a molecular entity
Pure active ingredient (example: Acetaminophen)
Name the 4 types of pharmaceutical companies
- Ethical
- Generic
- Biotech
- Contract research organizations (CROs)
Ethical Pharmaceutical Companies
- Innovative approach, they discover new molecular entities
- Heavy investment in research
- Very large companies
Generic Pharmaceutical Companies
-Do not discover new entities but rather build off existing ones through manufacturing
methods
-They also focus on adapting products no longer protected by patents
Very large to medium sized companies
Biotech Companies
-Mainly research based and focus on a few specialized products
-They are often bought by larger companies once they make a discovery
Small company
, Contract Research Organizations (CROs)
Hired by big pharm. companies to provide a specialized service (such as synthesis of a
certain molecules, or conducting clinical trials)
Small to medium sized company
Explain the difference between molecular entity and product
Molecular entity = pure active ingredient (e.g. Acetaminophen)
Product = the molecular entity along with the additives (such as anti-histamine) to create
the drug as a whole (like tylenol)
Define the Drug Candidate
-This is identified after 1-3 years of science research through synthesis of new
compounds from raw materials or by using research known in the market.
- During this stage, structures, data and testing are all internal company information.
- You do not need to get any outside approval to go into development.
Investigational New Drug (IND) Definition
- This is a 'public' phase because the company applies to the FDA for clinical trials.
All these, including preclinical and clinical data from animal trials, information about the
manufacturing process, and protocols undertaken, must be documented in the public
document.
What is New Drug Application (NDA)?
The final stage, wherein a company applies to the FDA to enter the market after all the
clinical trials have been carried out and approved.
Here, the FDA ensures the efficiency of the drug by asking if the benefits of the drug
outweigh the risks and if so give the product appropriate labeling (dosage, warnings,
etc.)
Abbreviated New Drug Application definition
Drugs Definition
Chemical substances used for the treatment, prevention or diagnosis of disease and
have been shown to enhance quality of life
Name the two types of Drugs
Biologics
Small Molecules
Biologics and examples
- Made using living organisms (plants, animals.)
- High molecular weight (>2000)
-examples: vaccines, antibodies
Small molecules and examples
- Made through chemical synthesis
- Low molecular weight (<2000)
-examples: steroid, antibiotics
The pharmaceutical industry characteristics
- Highly regulated (long process to be FDA approved)
- Research intense
- High risk of failure but also high profit if successful
,Define a molecular entity
Pure active ingredient (example: Acetaminophen)
Name the 4 types of pharmaceutical companies
- Ethical
- Generic
- Biotech
- Contract research organizations (CROs)
Ethical Pharmaceutical Companies
- Innovative approach, they discover new molecular entities
- Heavy investment in research
- Very large companies
Generic Pharmaceutical Companies
-Do not discover new entities but rather build off existing ones through manufacturing
methods
-They also focus on adapting products no longer protected by patents
Very large to medium sized companies
Biotech Companies
-Mainly research based and focus on a few specialized products
-They are often bought by larger companies once they make a discovery
Small company
, Contract Research Organizations (CROs)
Hired by big pharm. companies to provide a specialized service (such as synthesis of a
certain molecules, or conducting clinical trials)
Small to medium sized company
Explain the difference between molecular entity and product
Molecular entity = pure active ingredient (e.g. Acetaminophen)
Product = the molecular entity along with the additives (such as anti-histamine) to create
the drug as a whole (like tylenol)
Define the Drug Candidate
-This is identified after 1-3 years of science research through synthesis of new
compounds from raw materials or by using research known in the market.
- During this stage, structures, data and testing are all internal company information.
- You do not need to get any outside approval to go into development.
Investigational New Drug (IND) Definition
- This is a 'public' phase because the company applies to the FDA for clinical trials.
All these, including preclinical and clinical data from animal trials, information about the
manufacturing process, and protocols undertaken, must be documented in the public
document.
What is New Drug Application (NDA)?
The final stage, wherein a company applies to the FDA to enter the market after all the
clinical trials have been carried out and approved.
Here, the FDA ensures the efficiency of the drug by asking if the benefits of the drug
outweigh the risks and if so give the product appropriate labeling (dosage, warnings,
etc.)
Abbreviated New Drug Application definition
