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Clinical trials, Phase I, Phase III, Phase 0, Phase II, Phase IV,…
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Phase I
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and we cannot expose healthy humans to such a toxicity,
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Objective: To establish safety, to know the actions (biological effects),
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Here, the drug is tested in normal human volunteers,
(extremes of ages ; elderly and children are excluded)
As the drug is not tested in the patients, so we cannot determine efficacy in this phase
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The idea of testing the new drug in normal humans is based on the fact
that healthy persons are more likely to tolerate the adverse effects of the drug than diseased persons
Phase III
Purpose: To confirm therapeutic efficacy
– To establish the value of drug in relation to existing therapy
Here the drug is tested in large number of patients at several centers to include patient with different genetic makeup.
This is done to generalize the results of the study to variable genetic and ethnic groups
If the drug is found to be safe and effective in these trials,
then another application is filed with FDA (New Drug Application or NDA) to market the drug
If approval is granted, the drug is marketed
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if phase II establishes that the drug is useful and
generally safe, phase III clinical trials are undertaken
Objective: to confirm efficacy, to establish safety, to identify latent side effects, tolerance, design ideal dosage range and to compare with the existing drug
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Phase 0
Analysis: Analysis is done by highly sensitive methods like accelerated mass spectrometry and positron emission tomography (PET)
Objective: A very small dose is used to evaluate pharmacodynamics and pharmacokinetics in human beings
and are exposed to drug for shorter period
it is called as microdosing studies , it is a recent approach in clinical trials to cut cost in drug development
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Phase II
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Objective: To establish efficacy, detect adverse effects and pharmacokinetics
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if the phase I is successful, the compound
undergoes phase II
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Phase IV
if phase III studies are satisfactory, the new drug is
marketed
No of subjects: 2000 to >10000 patients
Objective: since earlier phases involve a relatively small number of patients for a shorter time,
they cannot be expected to provide full safety information.
Thus, post marketing surveillance is done for systemic evaluation, detection of longterm safety and to identify other possible therapeutic uses
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purpose: – To know rare and long-term adverse effects
Special groups like children, pregnancy etc can be tested
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IND
If the drug is found to be promising in these studies,
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If the permission is granted, then drug is tested in humans
This testing is called clinical trials
Before a new drug comes to the market,
it is extensively tested in animals and in vitro studies for safety and efficacy
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GCP
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International Conference for Harmonization, so that
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