What is clinical trials and phases Slideshare?
Clinical trial is a systematic investigation in human subjects for evaluating the safety & efficacy of any new drug. Clinical trial is a systematic investigation in human subjects for evaluating the safety & efficacy of any new drug.
What is a clinical trial Slideshare?
Definition • Clinical trials mean a systematic study of a new drug ( therapy protocols, devices ) in human subjects to generate data for discovering or verifying the clinical claims or pharmacological and adverse effects with an aim to determine the safety and efficacy of drugs in question.
What is a Phase 1 clinical trial?
The first step in testing a new treatment in humans. A phase I clinical trial tests the safety, side effects, best dose, and timing of a new treatment. It may also test the best way to give a new treatment (for example, by mouth, infusion into a vein, or injection) and how the treatment affects the body.
How many phases are there in clinical trials?
There are 3 main phases of clinical trials – phases 1 to 3. Phase 1 trials are the earliest phase trials and phase 3 are later phase trials. Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed.
What is GCP PPT?
Good Clinical Practice (GCP) • An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human beings, Public assurance that the rights, safety, and well being of trial subjects are protected • Results in credible data • …
What is a Phase 0 clinical trial?
Phase 0 of a clinical trial is done with a very small number of people, usually fewer than 15. Investigators use a very small dose of medication to make sure it isn’t harmful to humans before they start using it in higher doses for later phases.