MCQs on Clinical trials

4
(9)

Preclinical trial:

  • Done on laboratory animals
  • Good clinical practices (set of guidelines to be followed while conducting a clinical trial) is not applicable in this phase.

 

Phase 0:

  • Microdosing study
  • Subtherapeutic dose applied on small group of healthy human volunteers
  • Determines pharmacokinetics (especially bioavailability).

 

Investigational new drug (IND):

  • Application to conduct a human study for a new drug
  • IND is submitted between preclinical studies and phase 1.

 

Phase 1:

  • Small group of healthy human volunteers
  • Pharmacokinetics & pharmacodynamics > Safety
  • Dosing route
  • Bioavailability
  • Maximum tolerable dose
  • Toxicity is best assessed in phase 1 (but overall assessed in all phases).

 

Phase 2:

  • Done on small group of patients
  • Dosing range
  • Maximum risk of drug failure
  • Drug efficacy is first determined in phase 2.

 

Phase 3:

  • Large group of patients
  • Best phase for determining drug efficacy & safety
  • Confirm the actual dose.

 

New drug application (NDA):

  • Application for marketing a new drug
  • NDA is submitted between phase 3 & 4.

 

Phase 4:

  • Postmarketing surveillance
  • Done on general population
  • Detection of rare and chronic adverse effects
  • Minimum duration: 2 years.

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