CITI TRAINING EXAM 150 QUESTIONS WITH VERIFIED
AND UPDATED CORRECT SOLUTIONS/A+ GRADE/2023-
2024 VERSION
What must you file before conducting human
... [Show More] clinical trials with an experimental drug? -
correct answer IND application (Form FDA 1571)
During the clinical development phase of the IND process, what must sponsors do? -
correct answer Maintain current IND application by amending IND with new Form FDA
1571 and providing FDA with:
safety updates
copies of new protocols
FDA 1572
Annual Progress reports
this document notifies FDA of relevant changes in investigators conducting clinical trials
under the IND. - correct answer Form FDA 1572
What is the timeline of drug development? - correct answer Preclinical trials, IND
Submission,
Clinical Development (Phase I-III), NDA submission,
Marketing (Phase IV)
When does a sponsor submit the IND? - correct answer Prior to clinical development
phases (human trials). *30 day process.
What is the NDA? - correct answer New Drug Application, submitted prior to Phase IV
marketing phase.
How long does the NDA submission take? - correct answer 6 months - 2 years.
What is determined for a drug in the preclinical phase - correct answer
Pharmacokinetics and bioavailability Outcome shows promise of safety and efficacy
warranting additional studying.
How long does FDA have to review IND submission? - correct answer 30 days
How long is the clinical development phase (Phase 1-III) in process for IND? - correct
answer 6-7 years.
Determine the trial phase:
- Assess toxicity
- Determine drug's PK and PD profiles
- Determine doses resulting in sufficient biological level of drug - correct answer Phase I
Determine the trial phase:
CITI TRAINING EXAM 150 QUESTIONS WITH VERIFIED
AND UPDATED CORRECT SOLUTIONS/A+ GRADE/2023-
2024 VERSION
- Determine drug's effectiveness (primary goal)
- Determine long-term drug safety
- Confirm findings - correct answer Phase III
Determine the trial phase:
- Determine drug's short-term risk (safety) (primary goal)
- Examine preliminary effectiveness of drug - correct answer Phase II
Determine the trial phase from the subject population:
Controlled studies enrolling limited numbers of patients - correct answer Phase II
Determine the trial phase from the subject population:
Controlled and uncontrolled studies (but typically placebo-controlled and doubleblinded) enrolling larger patient numbers. - correct answer Phase III
Determine the trial phase from the subject population:
Normal healthy volunteers unless toxicity prevents exposure (e.g, cancer drugs). In this,
case patients with end-stage disease might be enrolled. - correct answer Phase I
If an IND application is submitted and the FDA has not contacted the physician within
30 days after acknowledging receipt, can the trial start? - correct answer Yes, one of
two conditions must be met.
1. 30 days elapsed since FDA received IND application [Show Less]