CNPR Drug Development Process 2 — Questions and Answers
Question 1: Which regulatory submission allows a pharmaceutical company to begin human clinical trials in the US?
- New Drug Application (NDA)
- Investigational New Drug (IND) Application (Correct answer)
- Biologics License Application (BLA)
- Abbreviated New Drug Application (ANDA)
Correct answer: Investigational New Drug (IND) Application
An IND application must be filed with the FDA and allowed to proceed before any human clinical testing can begin.
Question 2: What is the primary purpose of a Phase II clinical trial?
- To establish the drug's safety in healthy volunteers
- To assess efficacy and further evaluate safety in a larger patient population (Correct answer)
- To compare the drug to existing treatments in thousands of patients
- To monitor long-term effects after market approval
Correct answer: To assess efficacy and further evaluate safety in a larger patient population
Phase II trials enroll patients with the target disease to gather preliminary efficacy data and continue safety evaluation.
Question 3: The Hatch-Waxman Act (1984) was primarily designed to:
- Speed up approval of biologic drugs
- Facilitate generic drug entry by clarifying patent and data exclusivity rules (Correct answer)
- Require pediatric studies for all new drugs
- Establish the FDA's Breakthrough Therapy designation
Correct answer: Facilitate generic drug entry by clarifying patent and data exclusivity rules
Hatch-Waxman created the ANDA pathway and patent challenge mechanisms that allow generic drugs to reach market more quickly after brand exclusivity expires.
Question 4: In drug development, 'ADME' refers to which four pharmacokinetic processes?
- Action, Distribution, Metabolism, Elimination
- Absorption, Distribution, Metabolism, Excretion (Correct answer)
- Activation, Diffusion, Modification, Excretion
- Absorption, Diffusion, Metabolism, Efficacy
Correct answer: Absorption, Distribution, Metabolism, Excretion
ADME describes how a drug is absorbed into the body, distributed to tissues, metabolized (chemically transformed), and excreted.
Question 5: Which FDA designation is granted to drugs targeting serious conditions where the drug demonstrates substantial improvement over available therapies?
- Orphan Drug Designation
- Fast Track Designation
- Breakthrough Therapy Designation (Correct answer)
- Priority Review Designation
Correct answer: Breakthrough Therapy Designation
Breakthrough Therapy Designation provides intensive FDA guidance and may expedite development for drugs showing early clinical evidence of substantial improvement.
Question 6: What does 'bioavailability' measure in pharmacokinetics?
- The rate at which a drug reaches peak concentration in the blood
- The fraction of an administered dose that reaches systemic circulation unchanged (Correct answer)
- The volume of plasma cleared of a drug per unit time
- The time required for a drug's concentration to decrease by half
Correct answer: The fraction of an administered dose that reaches systemic circulation unchanged
Bioavailability (F) is the proportion of a drug dose that reaches the systemic circulation and is available to exert its pharmacological effect.
Question 7: A pharmaceutical company discovers a promising compound in the lab. What is the NEXT step before animal studies can begin?
- Filing an IND application
- Conducting preclinical in vitro testing (Correct answer)
- Submitting an NDA to the FDA
- Enrolling human volunteers for Phase I
Correct answer: Conducting preclinical in vitro testing
After discovery, compounds undergo in vitro (cell and biochemical) testing before progressing to animal (in vivo) preclinical studies.
CNPR Drug Development Process 2
Which regulatory submission allows a pharmaceutical company to begin human clinical trials in the US?