The scientists, physicians, and academicians who investigate the preclinical studies are busy individuals. They do not involve themselves in one study at a time but in multiple studies. Plus, they have their own clinical duties and responsibilities. This gives them little time to stay engaged in any of the preclinical studies. Thus, a preclinical research study suffers from a poor engagement by its investigators and its progress gets delayed. It can further impact the quality of the research res
Clinical research is as an experiment conducted on human beings to evaluate the safety & efficacy of new drugs, medical devices, new drug delivery systems etc. Several thousands of new drugs enter the market each year and unless they are tested in humans, we cannot accurately predict their effect on them. Thus, clinical trials become necessary.
But, many people in India consider preclinical research as a curse and state that “Human Beings are treated as Guinea Pigs.” They are concerne
Preclinical trials, also known as non-clinical trials are the laboratory tests of a new drug, device or medical treatment on animal subjects. The main aim of preclinical studies is to see whether the drug or the treatment really works and whether it is safe to test on humans.
Thus, the main goal of a preclinical research is to collect sufficient data and establish the safety profile of the drug or the treatment under question. And to fulfill this objective, various types of studies are carrie
The number of animals used in preclinical studies is continuously increasing. Each year millions of experimental animals across the world are sacrificed in the name of scientific research.
The pain, distress and death experienced by the animals during scientific experiments have been an issue of debate since long. Besides the major concern of ethics, there are few more disadvantages of using animals for scientific experiments, like requirement of skilled manpower, time consuming protocols, an
What is Good Laboratory Practice?
Good Laboratory Practice (GLP) encompasses a set of principles for defining a framework within which laboratory or preclinical studies are planned, performed, monitored, recorded, reported, and stored for future reference.
The need for GLP
GLP was first instituted in the US when FDA (Food and Drug Administration) discovered numerous cases of wrong data submission and poor laboratory practices by toxicology labs and pharmaceutical companies across the United S