What must you file before conducting human 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? C
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What must you file before conducting human 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:
- 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 double-blinded) 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.
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