Artemether and artemisinins
Artemisinins are isolated from the Artemisis annua or sweet wormwood. Artemisinins and its derivatives are powerful medicines known for their ability to reduce the number of Plasmodium parasites in the blood of patients with malaria. (Source: World Health Organization Q&A on artemisinins, updated April 2013)
Malaria is caused by Plasmodium parasites. The parasites are spread to people through the bites of infected Anopheles mosquitoes which bite mainly between dusk and dawn. There are four parasite species that cause malaria in humans of which Plasmodium falciparum is one, the most common and the most deadly. Most deaths occur among children living in Africa where a child dies every minute from malaria. (Source: World Health Organization Fact sheet no 94, updated December 2013)
Dysphagia is the medical term for swallowing difficulties. Signs of dysphagia include coughing or choking when eating or drinking or a sensation that food is stuck in the throat or chest. There are two types: swallowing difficulties caused by problems with the mouth or throat and swallowing difficulties caused by problems with the oesophagus. It is usually caused by another condition such as stroke, head injury, dementia or cancer. It can also occur in children as a result of a developmental or learning disability. (Source: www.nhs.uk.conditions/dysphagia)
The term neoplasm refers to an abnormal mass of tissue arising from an abnormal proliferation of cells. As this excessive growth persists, a lump or tumour is normally formed. (source: www.news-medical.net/health)
Phase I trials are the first stage of testing a potential new drug candidate in patients. These trials carefully evaluate the candidate’s safety in humans and typically involve several dozen healthy volunteers.
Phase II trials are usually larger than Phase I studies and may involve a more diverse group of volunteers. Phase II studies can enroll anywhere from a few dozen to several hundred volunteers. They gather more information about safety and may ask many of the same types if questions asked in Phase I studies perhaps with more details or different measures.
Phase I and Phase II studies may both look at the effects of different doses or dosing schedules and gather information about which strategy seems best for testing in larger trials. Some dose-ranging studies are described as a Phase IIa study.
A definite dose-range finding study in patients with efficacy as the primary endpoint. Source: www.ich.org/clinical
Updated: 13/7/14Print this page