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Pharmaceutics is the practice of preparing and/or dispensing drugs and medications, usually for the purpose of treating conditions and diseases or maintaining a state of good health. Retail stores that provide drugs are known as pharmacies, chemists or drugs stores.
In recent years the priorities of some pharmaceutical businesses has been questioned, with some businesses preventing the release of academic reports they have sponsored that reveal the health effects of some medications to the consumer.
The pharmaceutical and medicine manufacturing industry has produced a variety of medicinal and other health-related products undreamed of by even the most imaginative apothecaries of the past. These drugs save the lives of millions of people from various diseases and permit many ill people to lead normal lives.
Thousands of medications are available today for diagnostic, preventive, and therapeutic uses. In addition to aiding in the treatment of infectious diseases such as pneumonia, tuberculosis, malaria, influenza, and sexually transmitted diseases, these medicines also help prevent and treat cardiovascular disease, asthma, diabetes, and cancer. For example, antinausea drugs help cancer patients endure chemotherapy; clot-buster drugs help stroke patients avoid brain damage; and psychoactive drugs reduce the severity of mental illness for many people. Antibiotics and vaccines have virtually wiped out such diseases as diphtheria, syphilis, and whooping cough. Discoveries in veterinary drugs have controlled various diseases, some of which are transmissible to humans.
At each stage of life—from early infancy through old age—innovative drug discoveries help millions of patients lead longer, healthier, happier, and more productive lives. These longer life spans are due, in large part, to the conquest of diseases through drug research and drug manufacturing. But modern drugs do even more than save lives and improve the well-being of patients. As they improve health, they also save money by keeping people out of hospitals, emergency rooms, and nursing homes, thus reducing healthcare costs.
Advances in biotechnology and information technology are transforming drug discovery and development. Within biotechnology, scientists have learned a great deal about human genes, but the real work—translating that knowledge into viable new drugs—is just beginning. Many new drugs are expected to be developed in the coming years. Where it once took 15 years to develop a new drug, advances in technology and the knowledge of how cells work have allowed pharmaceutical and medicine manufacturing makers to shave years off that incubation period. New technology allows life scientists to test thousands of drug candidates in 1 day.
There is a direct relationship between gene discovery and identification of new drugs: the more genes identified, the more paths available for drug discovery. Discovery of new genes also can lead to new diagnostics for the early detection of disease. Among other uses, new genetic technology is being explored to develop vaccines to prevent or treat diseases that have eluded traditional vaccines, such as AIDS, malaria, tuberculosis, and cervical cancer.
The pharmaceutical and medicine manufacturing industry consists of about 2,500 places of employment, located throughout the country. These include establishments that make pharmaceutical preparations or finished drugs; biological products, such as serums and vaccines; bulk chemicals and botanicals used in making finished drugs; and diagnostic substances such as pregnancy and blood glucose kits.
The U.S. pharmaceutical industry has achieved worldwide prominence through research and development (R&D) work on new drugs, and spends a relatively high proportion of its funds on R&D compared with other industries. Each year, pharmaceutical industry testing involves many thousands of new substances, yet may eventually yield only 10 to 20 new prescription medicines.
For the majority of firms in this industry, the actual manufacture of drugs is the last stage in a lengthy process that begins with scientific research to discover new products and to improve or modify existing ones. The R&D departments in pharmaceutical and medicine manufacturing firms start this process by seeking new chemical compounds with the potential to prevent, combat, or alleviate symptoms of diseases or other health problems. Scientists use sophisticated tools, such as computer simulation and combinatorial chemistry, to hasten and simplify the discovery of potentially useful new compounds.
Most firms devote a substantial portion of their R&D budgets to applied research, using scientific knowledge to develop a drug targeted to a specific use. For example, an R&D unit may focus on developing a compound that will effectively slow the advance of breast cancer. If the discovery phase yields promising compounds, technical teams then attempt to develop a safe and effective product based on the discoveries.
To test new products in development, a research method called “screening” is used. To screen an antibiotic, for example, a sample is first placed in a bacterial culture. If the antibiotic is effective, it is next tested on infected laboratory animals. Laboratory animals also are used to study the safety and efficacy of the new drug. A new drug is selected for testing on humans only if it promises to have therapeutic advantages over drugs already in use, or is safer. Drug screening is an incredibly risky, laborious, and high-cost process—only 1 in every 5,000 to 10,000 compounds screened eventually becomes an approved drug.
After laboratory screening, firms conduct clinical investigations, or “trials,” of the drug on human patients. Human clinical trials normally take place in three phases. First, medical scientists administer the drug to a small group of healthy volunteers to determine and adjust dosage levels, and monitor for side effects. If a drug appears useful and safe, additional tests are conducted in two more phases, each phase using a successively larger group of volunteers or carefully selected patients.
After a drug successfully passes animal and clinical tests, the U.S. Food and Drug Administration (FDA) must review the drug’s performance on human patients before approving the substance for commercial use. The entire process, from the first discovery of a promising new compound to FDA approval, can take many years. However, scientific and information technology advances will shorten that process considerably for most drugs.
After FDA approval, problems of production methods and costs must be worked out before manufacturing begins. If the original laboratory process of preparing and compounding the ingredients is complex and too expensive, pharmacists, chemists, chemical engineers, packaging engineers, and production specialists are assigned to develop a manufacturing process economically adaptable to mass production. After the drug is marketed, new production methods may be developed to incorporate new technology or to transfer the manufacturing operation to a new production site.
In many production operations, pharmaceutical manufacturers have developed a high degree of automation. Milling and micronizing machines, which pulverize substances into extremely fine particles, are used to reduce bulk chemicals to the required size. These finished chemicals are combined and processed further in mixing machines. The mixed ingredients may then be mechanically capsulated, pressed into tablets, or made into solutions. One type of machine, for example, automatically fills, seals, and stamps capsules. Other machines fill bottles with capsules, tablets, or liquids, and seal, label, and package the bottles.
Quality control and quality assurance are vital in this industry. Many production workers are assigned full time to quality control and quality assurance functions, whereas other employees may devote part of their time to these functions. For example, although pharmaceutical company sales representatives, often called detailers, work primarily in marketing, they engage in quality control when they assist pharmacists in checking for outdated products.
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