File Details
Regulatory agencies - USFDA, EMEA, DCG (I) and scientific communication | |
File name | Regulatory agencies - USFDA, EMEA, DCG (I) and scientific communication |
File Description | The constantly
increasing clinical cost put the pharmaceutical industry under a lot of
pressure. The development of a drug is very expensive and long-lasting process
and unfortunately, not always successful. The drug development process includes
many steps and not always a newly-developed drug can reach the last phase of clinical
trials. There are couple phases of clinical trial that are essential for
discovery of potential drug candidates and in which safety of patients,
efficacy and toxicology are with high priority. After a drug has been
discovered/developed, the next step is approval by FDA and this indicates the
start of any clinical trial. The process of approval of a new drug is long and
requires many people to be involved. IND (investigational new drug) application
should be on place from the sponsor and submitted to FDA. There are many
players in clinical trial like sponsor, investigator, audit, needed for
successful completion of a study. |
Category Name | School of Clinical Research |
Subject Name | Clinical Trails |
Module Name | General Files |
Micro Category Name | -- |
Level | |
File Type | |
File | Login to Download |
File | Login to Download |