RE: 2015 Jul 2019 14:02
Decide for yourself where VAL 201 is borgie..
PHASE - 1
A new drug that reaches this stage has crossed the pre-clinical research stages. It has been tested on other life forms to rule out extreme fatalities prior to human clinical trials. In phase 1 the focus is on analyzing the safety aspects of the drug. Usually, healthy volunteers, who are paid for their participation, are administered these drugs. An outline of how the drug reacts with a human system upon entering until it exits the body is created and analyzed. Using these details, doses are also estimated for use in other levels. A majority of drugs in development pass this stage, especially those drugs which undergo pre-clinical tests have a better chance of success. It is a relatively short phase due to a small number of subjects and it being an introductory phase.
PHASE - 2
This phase is considered a true pilot trial since the drug is administered for the first time to patients who suffer from the condition that the new drug is proposed to treat. The number of patients who participate is usually kept to a minimum for health reasons. While the small sample size of testing will not show the beneficial nature of a drug, it does help provide additional safety details about side-effects and adverse reactions. This phase also helps in formulating better doses for further trials. This phase, like phase 1, is relatively short and can last up to two years due to a small population of subjects. But due to monitoring of safety and analyzing dosages, time taken may increase.
PHASE - 3
This is the last phase of the clinical trial before the drug and its associated reports is sent to a regulator for approval. This phase involves a large number of trial subjects from 300 to 3000. All of the trial subjects suffer from the condition that the new drug is supposed to treat and cure. Due to the large sample size and the additional monitoring procedures involved, the duration of this phase is the longest taking from one year up to four years and beyond in some cases.
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