Liptis is a global player in Pharmaceuticals, Nutraceuticals, and Consumer Health Care products.
Liptis is a global player in pharmaceuticals, consumer health care products, and animal health care products. Outstanding Global Brands, New Products, in the Research Pipeline Liptis improves the lives of people around the world with its outstanding products. And other innovative medicines are on the way. With research and development programs focused on small molecules, and biotechnology, Liptis is exploring more new products for medical conditions such as diabetes, osteoarthritis, musculoskeletal diseases, hypercholesterolemia and sexual dysfunction.
Liptis has a long history of pioneering developments in pharmaceuticals with leading products in the areas of women's health care, musculoskeletal disorder and cardiovascular therapy.
Liptis is also a leader in the development of nutraceuticals.
After an experimental drug is discovered, research is conducted to help determine its potential for treating or curing an illness. This is called preclinical research. Animal studies are conducted to determine if there are any harmful effects of the drug and to help understand how the drug works. Information from these experiments is submitted to the FDA in an Investigational New Drug (IND) Application. The FDA reviews information in an IND Application and decides if the drug is safe to study in humans.
In Stage 2, the experimental drug is studied in humans. The studies are known as clinical trials. Clinical trials are carefully designed and controlled experiments in which the experimental drug is administered to patients to test its safety and to determine if it works to treat or cure a specific disease (effectiveness). The professional team that oversees these studies includes the pharmaceutical company, physician investigators, regulatory authorities, and committees that review the safety and ethics of the clinical trial. These groups are involved to preserve the integrity and safety of the clinical trials.
The pharmaceutical companies that sponsor experimental drugs devote a great amount of time to clinical testing. Stage 2 is the most complex part of the drug approval process because of the numerous clinical trials involved and the high level of detail that is documented by the company.
The four general phases of clinical research are described below:
Phase I
The studies in Phase I of clinical research are generally conducted with healthy volunteers who are not taking other medicines; patients with the illness that the drug will treat are not tested at this stage. Ultimately, Phase I studies will show how the experimental drug affects the body of a healthy individual. Phase I consists of a series of small studies consisting of "tens" of volunteers. Tests are done on each volunteer throughout the study to see how the person's body processes, responds to, and is affected by the drug. Usually both low and high doses of the drug are studied. As a result, the safe dosage range in volunteers may be known, by the end of Phase I. This information will determine whether the drug proceeds to Phase II.
Phase II
The goal of Phase II is to understand how the experimental drug affects people who have the disease to be treated. Phase II usually consists of a limited number of studies that help determine the drug's short-term safety, side effects, and general effectiveness. The studies in Phase II are, in most cases, controlled investigations, meaning they involve a comparison between the new experimental drug and a sugar pill (placebo), or perhaps between the new drug and an existing drug. This comparison helps to minimize bias in interpreting the trials. Information gathered in Phase II studies will determine whether the drug proceeds to Phase III.
Phase III
Phase III consists of numerous clinical trials that are used to more fully investigate the nature of the drug. These trials are different than the Phase II trials because a larger number of patients are studied (sometimes in the thousands) and because the studies are of longer duration than Phase II studies. Another difference is the type of patients included. Phase III studies can include patients who have more than one illness and are taking medications in addition to the experimental drug used in the study. Therefore, the patients in Phase III studies more closely reflect the general population.
The information from Phase III forms the basis for most of the drug's initial labeling, which will guide physicians on how to use the drug.
Phase IV
Phase IV studies are conducted after a drug is approved. Companies often conduct Phase IV studies to more fully understand how their drug compares to other drugs treating the same illness. Also, the FDA may require additional studies after the drug is approved. FDA-required Phase IV studies often investigate the drug in specific types of patients that may not have been included in the Phase III studies. FDA-required Phase IV studies can also involve very large numbers of patients to further assess the drug's safety.
After Phase III, the pharmaceutical company prepares reports of all studies conducted on the drug and submits the reports to the FDA in a New Drug Application (NDA). The FDA then reviews the information in the NDA to determine if the drug is safe and effective for its intended use. Occasionally, the FDA will ask experts for their opinion of the drug; this occurs at advisory committee meetings. These meetings are usually open to the public. If the FDA determines that the drug is safe and effective, the drug will be approved.
After the FDA has approved the experimental drug, the pharmaceutical company can make it available to physicians and their patients. This is the "marketing" phase of the drug. A company may also continue to conduct research to discover new uses for the drug. Each time a new use for a drug is discovered, the drug is once again subject to the entire FDA approval process before it can be marketed for that purpose.
This process of research, testing, review, and approval helps to ensure that drugs marketed in the United States are safe and effective. Similar systems around the world provide the same assurances. There is also a process to monitor for adverse events. As a result, people everywhere can enjoy the health benefits of modern science rather than the "hit or miss" methods of old.
