BPS 2110 - Midterm 1 Exam Questions And Correct Answers
What are drugs? - ANSWER Chemical substances that are used in the treatment,
prevention or diagnosis of disease.
What are the 2 main types of drugs? - ANSWER -Biologic
-Small molecule
What is a biologic drug? - ANSWER A drug with a high molecular weight, that is
manufactured using living things.
What are examples of biologic drugs? - ANSWER -Vaccine
-Protein
-Antibody
-Nucleic acid
What is a small molecule? - ANSWER A medication with a low weight molecular, that is
produced by using living things and chemical synthesis.
Why are medications so costly? - ANSWER Because they are high risk.
What are the two major types of pharmaceutical companies? - ANSWER -Ethical
-Generic
What is an ethical pharmaceutical company? - ANSWER A company that invests
thoroughly in research. They discover and develop new molecular entities.
,Which of the two is a larger pharmaceutical company in terms of employees? - ANSWER
Ethical companies
What is a generic pharmaceutical company? - ANSWER A company manufacturing
products that are not protected by patent.
What is the main objective of a generic pharmaceutical company? - ANSWER Break and
adapt patent.
Name and explain why generic pharmaceutical companies are cheaper than ethical
pharmaceutical companies. - ANSWER Because the molecular entity, that is, the active
ingredient, has already been produced. As such, less money is invested in research.
What is a biotech company? - ANSWER A company established to commercially exploit
academic discoveries. They convert an academic research product into a saleable
product.
What is a CRO? - ANSWER A company providing specialty services for the industry of
pharmaceuticals.
What is Compendium of Pharmaceuticals and Specialties? - ANSWER List of interactions
between active molecules on various types of drugs.
What is the molecular entity? - ANSWER The active ingredient in the drug.
What is a pharmaceutical product? - ANSWER A drug is one of many types.
What does most of the money invested in developing a new drug actually go to? -
ANSWER Bureaucracy expenses, meaning paperwork.
What is the initial process in making a new medication? - ANSWER Drug discovery.
, How long does it take to make the discovery? - ANSWER 1-3 years.
What will be the result from the drug discovery process? - ANSWER A Drug Candidate.
What is a drug candidate? - A picture of the active molecule on a sheet of paper.
What is the second stage of producing a new drug? - The Development phase.
How long is the development phase? - 1 to 2 years.
What is the result of the development phase? - An Investigational New Drug - IND.
What is Investigational New Drug? - ANSWER Application to FDA for a clinical trial
What is the third stage of the production of new drug? - ANSWER Clinical Trial
How long is the clinical trial phase? - ANSWER 1 to 5 years.
What is the purpose of a clinical trial phase? - ANSWER To test the drug in humans on
safety and efficacy.
What is the result of the clinical trial phase? - ANSWER A New Drug Application or NDA.
What is a New Drug Application or NDA? - ANSWER An application made to the FDA to
produce this new drug.
What is the fourth stage in producing a new drug? - ANSWER FDA Approval
What are drugs? - ANSWER Chemical substances that are used in the treatment,
prevention or diagnosis of disease.
What are the 2 main types of drugs? - ANSWER -Biologic
-Small molecule
What is a biologic drug? - ANSWER A drug with a high molecular weight, that is
manufactured using living things.
What are examples of biologic drugs? - ANSWER -Vaccine
-Protein
-Antibody
-Nucleic acid
What is a small molecule? - ANSWER A medication with a low weight molecular, that is
produced by using living things and chemical synthesis.
Why are medications so costly? - ANSWER Because they are high risk.
What are the two major types of pharmaceutical companies? - ANSWER -Ethical
-Generic
What is an ethical pharmaceutical company? - ANSWER A company that invests
thoroughly in research. They discover and develop new molecular entities.
,Which of the two is a larger pharmaceutical company in terms of employees? - ANSWER
Ethical companies
What is a generic pharmaceutical company? - ANSWER A company manufacturing
products that are not protected by patent.
What is the main objective of a generic pharmaceutical company? - ANSWER Break and
adapt patent.
Name and explain why generic pharmaceutical companies are cheaper than ethical
pharmaceutical companies. - ANSWER Because the molecular entity, that is, the active
ingredient, has already been produced. As such, less money is invested in research.
What is a biotech company? - ANSWER A company established to commercially exploit
academic discoveries. They convert an academic research product into a saleable
product.
What is a CRO? - ANSWER A company providing specialty services for the industry of
pharmaceuticals.
What is Compendium of Pharmaceuticals and Specialties? - ANSWER List of interactions
between active molecules on various types of drugs.
What is the molecular entity? - ANSWER The active ingredient in the drug.
What is a pharmaceutical product? - ANSWER A drug is one of many types.
What does most of the money invested in developing a new drug actually go to? -
ANSWER Bureaucracy expenses, meaning paperwork.
What is the initial process in making a new medication? - ANSWER Drug discovery.
, How long does it take to make the discovery? - ANSWER 1-3 years.
What will be the result from the drug discovery process? - ANSWER A Drug Candidate.
What is a drug candidate? - A picture of the active molecule on a sheet of paper.
What is the second stage of producing a new drug? - The Development phase.
How long is the development phase? - 1 to 2 years.
What is the result of the development phase? - An Investigational New Drug - IND.
What is Investigational New Drug? - ANSWER Application to FDA for a clinical trial
What is the third stage of the production of new drug? - ANSWER Clinical Trial
How long is the clinical trial phase? - ANSWER 1 to 5 years.
What is the purpose of a clinical trial phase? - ANSWER To test the drug in humans on
safety and efficacy.
What is the result of the clinical trial phase? - ANSWER A New Drug Application or NDA.
What is a New Drug Application or NDA? - ANSWER An application made to the FDA to
produce this new drug.
What is the fourth stage in producing a new drug? - ANSWER FDA Approval
