Clinical trials are basically conducted to find out or evaluate the efficacy and safety of new drugs and devices. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment. Trials are essential to determine if the drug can be approved for use by CDSCO.
A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
A Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last for several years.
A Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the CDSCO agrees that the trial results are positive, it will approve the experimental drug or device.
A Phase IV trial for drugs or devices takes place after the CDSCO approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.
Epidemiological studies serve to generate knowledge of the distribution and determinants of disease frequency. Many large-scale epidemiological studies have led to widespread primary preventions of different diseases. APJ ERIC conducts national level population wide studies that encompasses the dental knowledge, society and lifestyle changes, socio-economic differences and accessibility.
It is a process of measuring the properties or performance of products. It seeks to ensure that consumers can understand what products will do for them and which products are of the best value.Subjecting products to stresses and dynamics beyond working conditions.Reproducing the types of damage to products found from consumer usage.Controlling the uniformity of production of products or components.