PRECLINICAL DEVELOPMENT 101
Drug development is an expensive, long, complicated, and time-consuming process, fraught with an extremely high level of uncertainty regarding the efficacy of a drug. The unknown pathophysiological causes of many neurological disorders make targeted drug discovery difficult. Although many drugs have met with significant success, some drugs fail in clinical trials because they do not provide sufficient benefit to justify their cost.
Most medical device trials are unsuccessful because they do not address enough of the patient’s health concerns. In most cases, drugs are not approved due to their potential side effects, and in some cases, drugs are marketed despite their known side effects. Many pharmaceutical companies spend millions of dollars a year on research and development but have only produced a fraction of what they have invested in developing new drugs. Drug development involves a combination of scientific discoveries, and the ability to develop medicines for specific diseases, as well as the ability to design devices that help patients.
The development of Biologics has been made possible by the application of new molecular techniques in drug discovery and in biopharmaceutical manufacturing. Engineered biologic systems have been created that produce small amounts of therapeutic proteins in the form of drug-like molecules that interact with cells. The introduction of engineered biologics in the pharmaceutical industry has dramatically increased the efficacy of drugs in clinical trials, resulting in the successful development of new medicines.
The goal of biopharmaceutical production is to manufacture a drug of the highest possible quality at the lowest possible cost. The goal of drug manufacturing is to provide an excellent therapeutic drug at the most affordable price possible. Pharmaceutical plants must also meet stringent safety standards, including guidelines on everything from the methods used in the production process to the packaging of the finished product to the storage environment for the product. All of these processes are necessary to provide the best possible quality of health care products. While the pharmaceutical industry is highly regulated, the Food and Drug Administration (FDA) is not involved in the approval process for new drugs. When drugs fail to meet the requirements of the FDA, the manufacturer is not required to compensate the public if the drug is found to be unsafe.
Read some of our articles below to gain an understanding of how preclinical testing impacts human health.