New Drug Development Flashcards
What is the first stage of drug development?
Discovery and Preclinical Testing
True or False: Clinical trials are conducted before preclinical testing.
False
What does the term ‘IND’ stand for in drug development?
Investigational New Drug
Fill in the blank: The primary goal of the __________ phase is to assess safety and dosage.
Phase I
Which phase of clinical trials focuses on efficacy and side effects?
Phase II
What is the purpose of Phase III clinical trials?
To confirm effectiveness, monitor side effects, and compare with standard treatments.
True or False: A drug must pass all three phases of clinical trials before it can be approved.
True
What is the role of the FDA in drug development?
To review and approve new drugs for safety and efficacy.
Multiple Choice: Which of the following is NOT a phase of clinical trials? A) Phase I B) Phase II C) Phase IV D) Phase V
D) Phase V
What is a key factor evaluated during preclinical testing?
Toxicity and pharmacokinetics
Fill in the blank: After successful clinical trials, a company submits a __________ to the FDA.
New Drug Application (NDA)
True or False: Post-marketing surveillance is unnecessary once a drug is approved.
False
What is the purpose of post-marketing surveillance?
To monitor the long-term effects and safety of a drug after it is on the market.
What type of study design is commonly used in Phase III trials?
Randomized controlled trials
Multiple Choice: Which of the following best describes the purpose of Phase II trials? A) Determine safety B) Determine efficacy C) Long-term effects D) Market readiness
B) Determine efficacy
What is a common reason for the failure of drug candidates during development?
Lack of efficacy or unacceptable side effects
Fill in the blank: The __________ is responsible for regulating the approval of new drugs in the United States.
Food and Drug Administration (FDA)
True or False: The drug development process can take over a decade.
True
What is an important consideration during the drug discovery phase?
Identifying a viable target and mechanism of action
Which phase of clinical trials involves the largest number of participants?
Phase III
What is a ‘clinical endpoint’?
A measurable outcome used to determine the effect of a treatment in a clinical trial.
Fill in the blank: __________ studies assess how a drug is absorbed, distributed, metabolized, and excreted in the body.
Pharmacokinetic
True or False: A drug can be marketed before the completion of all clinical trials.
False
What does ‘orphan drug’ refer to?
A drug developed for rare diseases with few patients.
Multiple Choice: What is a common method used to test drug safety in animals? A) In vitro testing B) Clinical trials C) Toxicology studies D) Pharmacogenomics
C) Toxicology studies
What is a ‘placebo’?
A substance with no therapeutic effect used as a control in clinical trials.
