IND
investigation new drug application
NDA
new drug application
Phase (in relation to Drug Development): Drug development is divided into
phases that are determined by the main objectives of the drug development
process.
* Preclinical: Laboratory or animal studies to show biological activity
of the compound against the targeted disease, with the compound evaluated for
safety and possible formulations.
* Phase 1 : A Phase 1 clinical trial is the first step in testing a new
investigational medication (or new use of a marketed drug) in humans. Phase 1
studies are mainly concerned with evaluating a drug’s safety profile,
including the safe dosage range. The studies also determine how the drug is
absorbed and broken down by the body, what is the best way to give the drug
to a patient (for example by mouth, or by injection), what side effects may
be likely, and how the drug is absorbed, distributed, metabolized, and
excreted as well as its duration of action. Except for drugs used to treat
cancer, Phase 1 clinical trials are usually conducted in healthy individuals
and are not intended to treat disease or illness. Because cancer can be such
a life-threatening condition, Phase 1 trials with anti-cancer drugs are
usually carried out in patients who already have the disease.
* Phase 1b : Phase 1b studies are usually conducted in patients diagnosed
with the disease, or condition for which the study drug is intended, who
demonstrate some biomarker, surrogate, or possibly clinical outcome that
could be considered for "proof of concept." Proof of concept in a Phase 1b
study typically confirms the hypothesis that the current prediction of
biomarker, or outcome benefit is compatible with the mechanism of action.
* Phase 1/2 : Phase 1/2 trials combine a Phase 1 and a Phase 2 trial of
the same treatment into a single protocol. First the Phase 1 part of the
trial is done - to determine the Maximum Tolerable Dose (MTD). Then, more
patients are treated at the MTD, in the Phase 2 portion of the study, to
further evaluate safety and/or efficacy.
* Phase 2 : Phase 2 clinical trials involve volunteers who have the
disease or condition to be treated. These trials help physicians and
researchers begin to learn more about the safety of the new drug treatment
and how well the drug treats the targeted disease or condition. Several
different doses of the drug may be looked at to see which dose has the
desired effects. Patients are monitored for side effects and for any
improvement in their illness, symptoms, or both.
* Phase 3 : After a drug has been shown to have positive results in small
groups of patients, it may be studied in a larger Phase 3 trial to confirm
efficacy and identify adverse events from long-term use. A Phase 3 trial
usually compares how well the study drug works compared with an inactive
placebo and/or another approved medication. One group of patients may receive
the new drug being tested, while another group of patients may receive the
comparator drug (already-approved drug for the disease being studied), or
placebo.
* Phase 4 : Phase 4 clinical trials are sometimes called "post-marketing"
trials because these studies begin after the Phase 1 – 3 study results have
been given to the FDA for evaluation. These studies may be done to determine
if the drug is effective against other disease states, or to test different
ways of taking the drug such as tablets, time-release capsules or syrups, or
to look for adverse events in larger populations over longer periods of time.
名詞解釋的網站
http://www.lillytrials.com/docs/terminology.html#N
FDA
http://www.fda.gov/
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