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- Phase 1 and 2 clinical trials are distinct stages in drug development, each serving specific objectives and involving different characteristics. The primary objective of Phase 1 trials is to evaluate the safety and tolerability of a drug or treatment candidate.
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Jun 22, 2019 · During phase I of a clinical trial, investigators spend several months looking at the effects of the medication on about 20 to 80 people who have no underlying health conditions. This phase...
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Jun 15, 2023 · After a phase 1 clinical trial, the investigators can begin a phase 2 trial. A phase 2 clinical trial focuses on treating a larger population with the disease or condition to begin studying the investigational drug’s effectiveness and to identify less common side effects not seen in phase 1 trials.
Phase II studies are sometimes divided into Phase IIa and Phase IIb. There is no formal definition for these two sub-categories, but generally: Phase IIa studies are usually pilot studies designed to find an optimal dose and assess safety ('dose finding' studies). [15]
Phase II trials are performed on larger groups of patients and are designed to assess the efficacy of the drug and to continue the Phase I safety assessments. Most importantly, Phase II clinical studies help to establish therapeutic doses for the large-scale Phase III studies.
Jun 11, 2024 · Phase 2 clinical trials aid drug development, bridging the gap between Phase 1 safety assessments and Phase 3 efficacy evaluations. These trials further our understanding of new treatments' therapeutic potential, gathering detailed data on effectiveness, dosage, and safety profiles.
At the end of phase 1, if the study treatment and method of administration appear safe in healthy people, the next phase of development is phase 2 where it is tested on a slightly larger number of people with the targeted disease.
Sep 2, 2021 · The purpose of Phase 1 is to ensure that the treatment is safe in humans and to determine how and where it distributes within the body. This testing normally takes place with a small group of healthy volunteers.
