Phase I
From DrugPedia: A Wikipedia for Drug discovery
(Difference between revisions)
| Line 1: | Line 1: | ||
The aim of the first clinical trials (phase I) on humans is to help evaluate and understand the behavior of the molecule or compound on healthy subjects. | The aim of the first clinical trials (phase I) on humans is to help evaluate and understand the behavior of the molecule or compound on healthy subjects. | ||
| - | These studies are designed to determine the pharmacodynamics and pharmacokinetics properties of the compound.These properties help to further design of well controlled scientifically valid Phase-II studies. | + | These studies are designed to determine the pharmacodynamics and pharmacokinetics properties of the compound.These properties help to further design of well controlled scientifically valid Phase-II studies.In Phase I studies, CDER can impose a clinical hold (i.e., prohibit the study from proceeding or stop a trial that has started) for reasons of safety, or because of a sponsor's failure to accurately disclose the risk of study to investigators. |
| - | + | ||
| - | In Phase I studies, CDER can impose a clinical hold (i.e., prohibit the study from proceeding or stop a trial that has started) for reasons of safety, or because of a sponsor's failure to accurately disclose the risk of study to investigators. | + | |
Revision as of 07:32, 31 July 2008
The aim of the first clinical trials (phase I) on humans is to help evaluate and understand the behavior of the molecule or compound on healthy subjects.
These studies are designed to determine the pharmacodynamics and pharmacokinetics properties of the compound.These properties help to further design of well controlled scientifically valid Phase-II studies.In Phase I studies, CDER can impose a clinical hold (i.e., prohibit the study from proceeding or stop a trial that has started) for reasons of safety, or because of a sponsor's failure to accurately disclose the risk of study to investigators.
