BPS 2110 - MIDTERM 1 QUESTIONS WITH VERIFIED
ANSWERS
What are drugs? - Answers - Chemical substances that are used in the treatment,
prevention or diagnosis of disease.
What are the 2 main types of drugs? - Answers - -Biologic
-Small molecule
What is a biologic drug? - Answers - A drug with a high molecular weight, that is
manufactured using living things.
What are examples of biologic drugs? - Answers - -Vaccine
-Protein
-Antibody
-Nucleic acid
What is a small molecule? - Answers - A drug with a low molecular weight, that is
manufactured using living things or chemical synthesis.
Why are drugs so expensive? - Answers - Because they are high risk.
What are the two main types of pharmaceutical companies? - Answers - -Ethical
-Generic
What is an ethical pharmaceutical company? - Answers - A company that invests
heavily in research. They discover and develop new molecular entities.
Which pharmaceutical company has more employees? - Answers - Ethical companies
What is a generic pharmaceutical company? - Answers - A company that manufacture
products that are not protected by patent.
What is the main goal of a generic pharmaceutical company? - Answers - To break and
adapt patents.
Why are generic pharmaceutical companies cheaper than ethical pharmaceutical
companies? - Answers - Due to the fact that the molecular entity (active ingredient) has
already been made. Therefore, not as much money is spent on research.
What is a biotech company? - Answers - A company created to exploit academic
discoveries. They transform an academic research product into a product to sell.
, What is a contract research organization (CRO)? - Answers - A company that provides
specialty services for the pharmaceutical industry.
What is the Compendium of Pharmaceuticals and Specialties? - Answers - A list of
interactions between active molecules in different types of drugs.
What is a molecular entity? - Answers - The active ingredient in the drug.
What is a pharmaceutical product? - Answers - A drug is one of many types.
What is the majority of the money spent on making a new drug really spent on? -
Answers - The cost of bureaucracy (paperwork).
What is the first stage of producing a new drug? - Answers - The discovery phase.
How long is the discovery phase? - Answers - 1 to 3 years.
What is the result of the discovery phase? - Answers - A Drug Candidate.
What is a drug candidate? - Answers - A picture of the active molecule on a sheet of
paper.
What is the second stage of producing a new drug? - Answers - The Development
phase.
How long is the development phase? - Answers - 1 to 2 years.
What is the result of the development phase? - Answers - An Investigational New Drug
(IND).
What is an investigational new drug (IND)? - Answers - An application to the FDA to get
a clinical trial.
What is the third stage of producing a new drug? - Answers - Clinical Trials.
How long is the clinical trial phase? - Answers - 1 to 5 years.
What is the reason for the clinical trial phase? - Answers - To test the drug in humans
for safety and efficacy.
What is the result of the clinical trial phase? - Answers - A New Drug Application (NDA)
What is a New Drug Application (NDA)? - Answers - An application made to the FDA to
produce this new drug.
ANSWERS
What are drugs? - Answers - Chemical substances that are used in the treatment,
prevention or diagnosis of disease.
What are the 2 main types of drugs? - Answers - -Biologic
-Small molecule
What is a biologic drug? - Answers - A drug with a high molecular weight, that is
manufactured using living things.
What are examples of biologic drugs? - Answers - -Vaccine
-Protein
-Antibody
-Nucleic acid
What is a small molecule? - Answers - A drug with a low molecular weight, that is
manufactured using living things or chemical synthesis.
Why are drugs so expensive? - Answers - Because they are high risk.
What are the two main types of pharmaceutical companies? - Answers - -Ethical
-Generic
What is an ethical pharmaceutical company? - Answers - A company that invests
heavily in research. They discover and develop new molecular entities.
Which pharmaceutical company has more employees? - Answers - Ethical companies
What is a generic pharmaceutical company? - Answers - A company that manufacture
products that are not protected by patent.
What is the main goal of a generic pharmaceutical company? - Answers - To break and
adapt patents.
Why are generic pharmaceutical companies cheaper than ethical pharmaceutical
companies? - Answers - Due to the fact that the molecular entity (active ingredient) has
already been made. Therefore, not as much money is spent on research.
What is a biotech company? - Answers - A company created to exploit academic
discoveries. They transform an academic research product into a product to sell.
, What is a contract research organization (CRO)? - Answers - A company that provides
specialty services for the pharmaceutical industry.
What is the Compendium of Pharmaceuticals and Specialties? - Answers - A list of
interactions between active molecules in different types of drugs.
What is a molecular entity? - Answers - The active ingredient in the drug.
What is a pharmaceutical product? - Answers - A drug is one of many types.
What is the majority of the money spent on making a new drug really spent on? -
Answers - The cost of bureaucracy (paperwork).
What is the first stage of producing a new drug? - Answers - The discovery phase.
How long is the discovery phase? - Answers - 1 to 3 years.
What is the result of the discovery phase? - Answers - A Drug Candidate.
What is a drug candidate? - Answers - A picture of the active molecule on a sheet of
paper.
What is the second stage of producing a new drug? - Answers - The Development
phase.
How long is the development phase? - Answers - 1 to 2 years.
What is the result of the development phase? - Answers - An Investigational New Drug
(IND).
What is an investigational new drug (IND)? - Answers - An application to the FDA to get
a clinical trial.
What is the third stage of producing a new drug? - Answers - Clinical Trials.
How long is the clinical trial phase? - Answers - 1 to 5 years.
What is the reason for the clinical trial phase? - Answers - To test the drug in humans
for safety and efficacy.
What is the result of the clinical trial phase? - Answers - A New Drug Application (NDA)
What is a New Drug Application (NDA)? - Answers - An application made to the FDA to
produce this new drug.
