Clinical trial phases – Phase 1

Clinical trial phases - Phase 1 1 Medicine Made Easy Research
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"Phase I trials aim to find the best dose of a new drug with the fewest side effects. The drug will be tested in a small group of 15 to 30 patients. Doctors start by giving very low doses of the drug to a few patients. Higher doses are given to other patients until side effects become too severe or the desired effect is seen. The drug may help patients, but Phase I trials are to test a drug’s safety. If a drug is found to be safe enough, it can be tested in a phase II clinical trial." - NCCN definition

A Phase I clinical trial evaluates the best way to administer a drug, its frequency, and dose, the maximum tolerated dose (MTD), and side effects. Tolerability, pharmacokinetics, and pharmacodynamics are evaluated.

These studies determine, most importantly, if the treatment is safe.

Trials usually include 20 to 100 patients and are monitored by the clinical researcher. Doses are increased if there are no severe side effects and patients are tested to determine if he or she is responding to the therapy. These escalation dose studies are used to determine the best and safest dose that can be administered and is a fraction of the dose that caused harm during animal testing.

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@peepso_user_10(Teodora Kasemiyar)
3 weeks ago

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