Investigational New Drug ( IND) Flashcards
What does IND stand for?
Investigational New Drug
True or False: An IND application is required before beginning clinical trials.
True
What are the three phases of clinical trials in the IND process?
Phase 1, Phase 2, and Phase 3
Fill in the blank: The primary purpose of Phase 1 trials is to assess the _____ of a drug.
safety
What is the main focus of Phase 2 clinical trials?
Efficacy and side effects
True or False: Phase 3 trials involve a larger patient population to confirm effectiveness.
True
What must be submitted to the FDA to initiate the IND process?
An IND application
What information is typically included in an IND application?
Preclinical data, manufacturing information, and clinical trial protocols
What is the role of the Institutional Review Board (IRB) in the IND process?
To review and approve the clinical trial protocols for ethical considerations
Multiple Choice: Which phase of clinical trials tests the drug on a small number of healthy volunteers? A) Phase 1 B) Phase 2 C) Phase 3
A) Phase 1
Fill in the blank: An IND application must include a _____ plan for the drug.
development
What is the significance of the Investigational New Drug (IND) status?
It allows the drug to be tested in humans for the first time.
True or False: The IND process is the same in all countries.
False
What is the purpose of preclinical studies in the IND process?
To gather data on the drug’s safety and biological activity before human testing.
What does the FDA stand for?
Food and Drug Administration
Multiple Choice: Which of the following is NOT a type of IND? A) Commercial IND B) Research IND C) Clinical IND
C) Clinical IND
What is the difference between a commercial IND and a research IND?
A commercial IND is for drugs intended for sale, while a research IND is for investigational use without a commercial intent.
Fill in the blank: The IND application must be updated with _____ data as it becomes available.
new
True or False: Once an IND is approved, it does not require further oversight.
False
What is the role of the FDA during the IND process?
To review the IND application and ensure the safety and rights of trial participants.
What happens if the FDA does not approve the IND application?
The sponsor cannot proceed with clinical trials.
Multiple Choice: What is a key requirement for an IND application? A) Market approval B) Preclinical study results C) Manufacturing history
B) Preclinical study results
What is the purpose of the safety monitoring phase in IND development?
To continuously assess the safety of the drug during clinical trials.
Fill in the blank: An IND must be submitted for any new drug intended for _____ testing.
human
