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BPS 2110 - Final Exam Questions and Answers 100% Solved

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BPS 2110 - Final Exam Questions and Answers 100% Solved What is the goal of Phase 1 of Clinical Trials? - Dose Finding How many patients are involved in Phase 1 of Clinical Trials? - Small number (<100) What type of patients are involved in Phase 1 of Clinical Trials? - Healthy volunteers ...

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  • October 30, 2024
  • 60
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
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NinjaNerd
©NINJANERD 2024/2025. YEAR PUBLISHED 2024.
BPS 2110 - Final Exam Questions and

Answers 100% Solved


What is the goal of Phase 1 of Clinical Trials? - ✔✔Dose Finding

How many patients are involved in Phase 1 of Clinical Trials? - ✔✔Small

number (<100)

What type of patients are involved in Phase 1 of Clinical Trials? -

✔✔Healthy volunteers

What is the average time taken for Phase 1 of Clinical Trials? - ✔✔< 1 year

What is the drug failure rate of Phase 1 of Clinical Trials? - ✔✔30%

What is the goal of Phase 2 of Clinical Trials? - ✔✔Safety and efficacy

How many patients are involved in Phase 2 of Clinical Trials? - ✔✔Medium

number (~200-300)

What type of patients are involved in Phase 2 of Clinical Trials? -

✔✔Patients

What is the average time taken for Phase 2 of Clinical Trials? - ✔✔~1 year

What is the drug failure rate of Phase 2 of Clinical Trials? - ✔✔~70%

,©NINJANERD 2024/2025. YEAR PUBLISHED 2024.
What is the goal of Phase 3 of Clinical Trials? - ✔✔Find rare side effects

How many patients are involved in Phase 3 of Clinical Trials? - ✔✔Large

number (~1000)

What is the average time taken for Phase 3 of Clinical Trials? - ✔✔~1 year

What type of patients are involved in Phase 3 of Clinical Trials? -

✔✔Patients

What is the drug failure rate of Phase 3 of Clinical Trials? - ✔✔~70%

What are the two general types of large pharmaceutical companies? -

✔✔Ethical pharmaceutical companies and generic pharmaceutical

companies

What are ethical pharmaceutical companies? - ✔✔Companies that invest

heavily in research. They discover and develop new molecular entities.

What are generic pharmaceutical companies? - ✔✔They focus on

breaking/ adapting patents and manufacturing methods and formulation.

What are drug products? - ✔✔Licensed products that contain the same

molecular entities in different forms.

What are molecular entities? - ✔✔The active ingredient in drugs.

,©NINJANERD 2024/2025. YEAR PUBLISHED 2024.
What is a drug candidate? - ✔✔The structure and all of the important

information regarding the chemical compound.

What is an IND? - ✔✔Investigational New Drug. An application made to the

FDA to enter development.

What is an NDA? - ✔✔New Drug Application. An application made to the

FDA to the enter the market.

What is an ANDA? - ✔✔Abbreviated New Drug Application. An application

made to the FDA to enter the market for generic drugs.

Why do drug companies prefer to treat chronic conditions rather than acute

ones? - ✔✔They are targeting the market rather than the disease. With

chronic conditions, the customer will need to purchase the drug for much

longer than acute conditions. This brings more money to the drug

company.

What are the three most common methods of lead identification in the

pharmaceutical industry? - ✔✔-High throughput screening.

-Rational drug design.

-Natural products

What characteristics make a good lead compound? - ✔✔-Proven biological

activity.

, ©NINJANERD 2024/2025. YEAR PUBLISHED 2024.
-Some specificity

-"Drug-like" properties

-Patent opportunity

What are two key difficulties associated with natural products in terms of

drug development? - ✔✔-Chemical synthesis of related compounds is

difficult.

-Limited to chemical modifications of the natural product.

Describe how drug companies perform safety testing during drug

development. - ✔✔-In-vitro testing, using biochemical assays, and looking

for a "clean" profile.

-Animal testing

List 4 different types of excipients and briefly explain their importance for

formulation. - ✔✔-Preservatives: Prevent mold and bacterial growth.

-Disintegrants: "Blows" the pill apart in the stomach.

-Binders: Hold ingredients together.

-Stabilizers: Protect from chemical degradation due to oxygen.

List 4 different types of formulation and provide a key advantage and

disadvantage of each. - ✔✔-Pills: Most convenient, does not by-pass the

liver.

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