Phase 2 Clinical Trial:
In phase 2 clinical trials evaluate the safety and effectiveness of new drugs or combination therapies.
As part of a phase 1 trial, healthy volunteers are recruited to determine the maximum and appropriate dose ranges, but a phase 2 trial evaluates whether or not a drug will eventually benefit patients and should be studied in a phase 3 trial to determine whether or not it will be effective in a specific population.
In phase 2 clinical trials, subjects are selected based on narrow criteria in order to allow close monitoring of a relatively homogeneous population of patients to evaluate the safety and efficacy of the drug.
In phase 2 clinical trials, safety parameters are also assessed to identify any adverse effects that may have been overlooked earlier or that are specific to a certain patient population, although information about safe and well tolerated doses is obtained during earlier phases of drug development.
An important goal of phase 2 trials is to determine the appropriate dose and treatment regimen for phase 3 trials.
The phase 2 trial will therefore enable dose response studies to be performed and confirmed.
Treatment in phase 2 is usually given to a larger number of patients than in phase 1, and doses are generally lower in phase 2 than in phase 1.
clinical trial phase 2 is further divided into 2 phases:
- Phase 2a
- Phase 2b
Phase 2a clinical trial:
The purpose of Phase 2a is to determine the dosing requirements. To determine whether there is a dose-response relationship, i.e., an increase in response with an increase in dose, a small number of patients are administered the drug with varying quantities.
It is also examined what is the optimal frequency of doses.
Phase 2b clinical trial:
Phase 2b trials aim to identify whether a drug is effective in treating, preventing, or diagnosing a specific disease based on how effective it is at treating, preventing, or diagnosing that disease.
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