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Phases of Clinical Trials

The document outlines the phases of clinical trials, starting with the discovery phase that identifies potential drug candidates, followed by preclinical testing in non-human models. It details the subsequent phases from Phase 0 to Phase 4, each focusing on different aspects of drug safety, efficacy, and monitoring, culminating in post-marketing surveillance after FDA approval. Each phase involves varying participant numbers and specific objectives to ensure thorough evaluation of new drugs.

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13 views2 pages

Phases of Clinical Trials

The document outlines the phases of clinical trials, starting with the discovery phase that identifies potential drug candidates, followed by preclinical testing in non-human models. It details the subsequent phases from Phase 0 to Phase 4, each focusing on different aspects of drug safety, efficacy, and monitoring, culminating in post-marketing surveillance after FDA approval. Each phase involves varying participant numbers and specific objectives to ensure thorough evaluation of new drugs.

Uploaded by

lactanciamarta
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Phases of Clinical Trials

Discovery

The discovery phase of clinical trials is the initial stage in drug development, focused
on identifying and validating potential drug candidates before they enter formal
clinical testing.
This phase focuses on identification of drug targets, discovery of lead compounds,
understanding mechanisms, safety & efficacy and formulation development.

Preclinical

The preclinical phase of clinical trials is a crucial stage that precedes testing a new
drug or therapy in humans. It involves rigorous testing in non-human models to
evaluate the drug's safety, efficacy, toxicity and pharmacokinetics.
Wide doses of the drug are tested using in vitro (test tube or cell culture) and in vivo
(animal) experiments, and it is also possible to perform in silico profiling using
computer models of the drug–target interactions.

Phase 0 (Human Micro Dosing studies)

Phase 0 represent a very early stage in drug development focused on obtaining


preliminary data about a new drug candidate's behaviour in humans.
No. of participants: 10-15
Dosage: 100 times lesser than the intended dose
Involves evaluation of safety, pharmacokinetics and pharmacodynamics.

Phase 1 (Human Pharmacology Phase)

Determines the drug’s safety profile, identify any side effects, route, maximum
tolerated dose and establish the appropriate dosage range and its timing.
Researchers also begin to understand how the drug behaves in the body.
No. of participants: 20-80 (Healthy participants)

Phase 2 (Therapeutic Exploratory Phase/Disease-Specific Phase)

Phase 2 of clinical trials focuses on evaluating the efficacy of a new drug or


treatment, while continuing to monitor its safety.
No. of participants: 100-300 (Disease-specific population)
Phase 2 trials are often divided into two parts:
1. Phase 2a: Focuses on determining the dosing requirements.
2. Phase 2b: Evaluates the drug’s efficacy.

Phase 3 (Therapeutic Confirmatory Phase)

Phase 3 clinical trials are designed to confirm the effectiveness of a new drug or
treatment, further evaluate its safety, and compare it to standard or existing
treatments.
No. of participants: 1000-3000
Participants are randomly assigned to receive either the new treatment, a standard
treatment, or a placebo.

FDA Approval

Phase 4 (Post Marketing Surveillance)

Phase 4 clinical trials occur after a drug has been approved for general use by
regulatory agencies. Their primary goals are to monitor the drug’s long-term
effectiveness and safety in the general population.
Researchers continue to evaluate safety, effectiveness, and any rare or long-term
side effects. They may also assess the drug’s impact on quality of life and its
effectiveness in different populations.

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