Drug Discovery
Clinical Research:
About Zest Clinical & Clinical Research
Zest Clinical understands the importance of drug development and the complex nature of a solution based industry. Zest Clinical Recruitment is a solutions based organisation that carefully searches and selects the right candidates suitable to work within the Clinical Research Industry.
Zest Clinical provides jobs and opportunities for:
Clinical Research has been defined as medical research to identify that a certain device, drug, or type of treatment is safe and effective in humans. Clinical Research typically involves Preclinical or Laboratory research in animal and human cells for a number of years before it is deemed suitable to be tested on human subjects.
A Phase I Studies:
Phase I studies are principally concerned with assessing the drug's safety. This preliminary phase of testing in humans is conducted in a small number of healthy volunteers (20 to 100), who are typically paid for participating in the study. The study is designed to assess what happens to the drug being tested in the human body to see how it is absorbed, metabolized, and excreted. A phase I study will investigate the side effects that occur when dosage levels are increased.
A Phase II Study:
When a drug has been tested to be safe, it must be tested for efficacy. This second phase of testing can take upto two years, and involve up to several hundred patients. The majority of phase II studies are randomised trials. One group of patients will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo. Often these studies are "blinded" this is when neither the patients nor researchers know who is getting the experimental drug. In this manner, the study can provide the CRO or pharmaceutical company and the FDA with comparative information about the relative safety of the new drug, and its effectiveness. It has been said, about one-third of experimental drugs successfully complete both phase I and phase II studies.
A Phase III Study:
During a phase III study, a drug is tested in several hundred to several thousand patients. This large-scale testing gives the Researchers and the FDA a more thorough understanding of the drug's effectiveness, benefits, and the range of possible adverse reactions. Most phase III studies are randomised and blinded trials.
Phase III studies can last for years, with 70%to 90% of drugs entering this phase III successfully complete this stage of testing. Pharmaceutical companies can request approval from the FDA approval to marketing the drug.
Post Marketing - Late Phase III/Phase IV Studies:
Late phase III/phase IV studies, the developers endeavor to compare a drug with other drugs already in the market. Also designed a study to monitor a drug's long-term effectiveness and impact on a patient's quality of life and finally to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.