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pharmaceutical industry
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What is the pharmaceutical industry?
The pharmaceutical industry focuses on the discovery, development, and manufacturing of drugs and medications by public and private organizations. This industry has evolved significantly, transitioning from relying on intuition and trial and error to the modern era that involves isolating and purifying compounds, chemical synthesis, and computer-aided drug design.
Modern pharmaceutical research, which began in the 19th century, has led to the creation of many safe and effective drugs. Today, the pharmaceutical industry is characterized by multinational corporations that operate on a global scale. These companies are driven by profit and competition, as they strive to discover cures for specific diseases.
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What kinds of products does the pharmaceutical industry make?
The pharmaceutical industry focuses on discovering, developing, and manufacturing drugs and medications. These pharmaceuticals can be classified by their chemical group, how they affect the body, and their therapeutic use.
Products of the pharmaceutical industry include:
* Medicines Substances or preparations used to treat disease
* Vaccines Used to prevent diseases like diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type B
* Drugs Substances used for diagnosis, treatment, or prevention of disease, and to restore or modify organic functions
* Antibiotics Used to combat infections
* Hormones Include glandular extracts such as insulin for treating diabetes
* Chemotherapy Used to decrease death and disability from cancer5 Britannica Sources- Synonyms of pharmaceuticals
- School Vaccine Mandates: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
- pharmaceutical
- pharmaceutical industry: Pharmaceutical industry in the modern era
- Birth Control: FDA Path to Over-the-Counter (OTC) Status
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How does the pharmaceutical industry develop new medicines?
The pharmaceutical industry develops new medicines through a multistep process that can take 10–15 years. It starts with basic research to identify potential new targets, such as drug receptors or enzymes. Thousands of chemical compounds undergo lab screening, with about 250 entering preclinical testing and only 5 making it to clinical testing.
Clinical trials, closely regulated by agencies like the FDA, have phases to test new drugs.
* Phase 1 trials test the drug for the first time in humans to determine a safe dosage.
* Phase 2 trials focus on the drug's effectiveness against a specific medical condition.
* Phase 3 trials compare the new drug to standard treatments using randomized designs to avoid bias.
* Phase 4 studies monitor the drug's long-term safety and effectiveness after it is already available on the market.3 Britannica SourcesCreated from Britannica articles using AI. AI can make mistakes, so verify using Britannica articles. -
What is clinical testing, and why is it important in making medicines?
Clinical trials formally test treatments or health-related interventions to determine their role in standard medical care. Before new drugs are accepted for general use, clinical trials determine if they have advantages over existing methods in health benefits, safety, or cost.
These trials follow a well-defined sequence regulated by agencies like the FDA in the U.S. and the EMA in Europe. The trials occur in phases, from Phase 0 to Phase 4, to ensure the drug's safety and effectiveness. These phases include testing for safety and dosage, determining effectiveness, comparing the new intervention to standard treatments, and collecting safety data.
Clinical trials are important because they are designed to allow safe and effective drugs to be marketed. They rely on scientific studies of the effects of drugs in animals and humans to determine if new drugs have a favorable risk-to-benefit ratio.
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How do government regulations affect the pharmaceutical industry?
Government regulations play a crucial role in the pharmaceutical industry, ensuring drug safety and efficacy for public health. These regulations, enforced by agencies, oversee drug development and marketing, requiring pre-market studies to determine a drug's risk-to-benefit ratio.
The regulatory process includes evaluating data from clinical trials, licensing manufacturing facilities, monitoring adverse drug reactions, and controlling the accuracy of drug promotion. Governments may support these agencies through tax funds or fees paid by pharmaceutical companies.
While aiming for harmonization, differing regulations across countries can pose challenges for multinational drug marketing, potentially increasing costs. Patents granted by governments allow pharmaceutical firms exclusive marketing rights, encouraging innovation by providing a period to recoup development costs before generic competition enters the market.
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What challenges does the pharmaceutical industry face in making medicines accessible to people around the world?
The pharmaceutical industry faces several challenges in ensuring global access to medicines. Disparities in regulations and guidelines across countries can complicate drug approval processes, increasing development costs.
Intellectual property laws, like drug patents, enable companies to charge high prices to recoup development costs, but this can make medications unaffordable in many regions. Conversely, some argue that government intervention and price setting may hurt innovation and access to drugs.
Effective vaccine distribution also relies on supply, logistics, and maintaining proper storage temperatures, which can be especially difficult in remote or low-resource settings.
4 Britannica Sources- intellectual-property law: Economic and ethical issues
- Questions About COVID-19 Answered: Once created, how are vaccines actually distributed?
- Prescription Drug Costs: Con 3: The U.S. government is already over-involved in health care and should leave prescription drugs to the free market.
- pharmaceutical industry: Pharmaceutical industry in the modern era
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News •
pharmaceutical industry, the discovery, development, and manufacture of drugs and medications (pharmaceuticals) by public and private organizations.
The modern era of the pharmaceutical industry—of isolation and purification of compounds, chemical synthesis, and computer-aided drug design—is considered to have begun in the 19th century, thousands of years after intuition and trial and error led humans to believe that plants, animals, and minerals contained medicinal properties. The unification of research in the 20th century in fields such as chemistry and physiology increased the understanding of basic drug-discovery processes. Identifying new drug targets, attaining regulatory approval from government agencies, and refining techniques in drug discovery and development are among the challenges that face the pharmaceutical industry today. The continual evolution and advancement of the pharmaceutical industry is fundamental in the control and elimination of disease around the world.
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The following sections provide a detailed explanation of the progression of drug discovery and development throughout history, the process of drug development in the modern pharmaceutical industry, and the procedures that are followed to ensure the production of safe drugs. For further information about drugs, see drug. For a comprehensive description about the practice of medicine and the role of drug research in the health care industry, see medicine.
History
The origin of medicines
Medicines of ancient civilizations
The oldest records of medicinal preparations made from plants, animals, or minerals are those of the early Chinese, Hindu, and Mediterranean civilizations. An herbal compendium, said to have been written in the 28th century bc by the legendary emperor Shennong, described the antifever capabilities of a substance known as chang shan (from the plant species Dichroa febrifuga), which has since been shown to contain antimalarial alkaloids (alkaline organic chemicals containing nitrogen). Workers at the school of alchemy that flourished in Alexandria, Egypt, in the 2nd century bc prepared several relatively purified inorganic chemicals, including lead carbonate, arsenic, and mercury. According to De materia medica, written by the Greek physician Pedanius Dioscorides in the 1st century ad, verdigris (basic cupric acetate) and cupric sulfate were prescribed as medicinal agents. While attempts were made to use many of the mineral preparations as drugs, most proved to be too toxic to be used in this manner.
Many plant-derived medications employed by the ancients are still in use today. Egyptians treated constipation with senna pods and castor oil and indigestion with peppermint and caraway. Various plants containing digitalis-like compounds (cardiac stimulants) were employed to treat a number of ailments. Ancient Chinese physicians employed ma huang, a plant containing ephedrine, for a variety of purposes. Today ephedrine is used in many pharmaceutical preparations intended for the treatment of cold and allergy symptoms. The Greek physician Galen (c. 130–c. 200 ad) included opium and squill among the drugs in his apothecary shop (pharmacy). Today derivatives of opium alkaloids are widely employed for pain relief, and, while squill was used for a time as a cardiac stimulant, it is better known as a rat poison. Although many of the medicinal preparations used by Galen are obsolete, he made many important conceptual contributions to modern medicine. For example, he was among the first practitioners to insist on purity for drugs. He also recognized the importance of using the right variety and age of botanical specimens to be used in making drugs.
Pharmaceutical science in the 16th and 17th centuries
Pharmaceutical science improved markedly in the 16th and 17th centuries. In 1546 the first pharmacopoeia, or collected list of drugs and medicinal chemicals with directions for making pharmaceutical preparations, appeared in Nürnberg, Ger. Previous to this time, medical preparations had varied in concentration and even in constituents. Other pharmacopoeias followed in Basel (1561), Augsburg (1564), and London (1618). The London Pharmacopoeia became mandatory for the whole of England and thus became the first example of a national pharmacopoeia. Another important advance was initiated by Paracelsus, a 16th-century Swiss physician-chemist. He admonished his contemporaries not to use chemistry as it had widely been employed prior to his time in the speculative science of alchemy and the making of gold. Instead, Paracelsus advocated the use of chemistry to study the preparation of medicines.
In London the Society of Apothecaries (pharmacists) was founded in 1617. This marked the emergence of pharmacy as a distinct and separate entity. The separation of apothecaries from grocers was authorized by King James I, who also mandated that only a member of the society could keep an apothecary’s shop and make or sell pharmaceutical preparations. In 1841 the Pharmaceutical Society of Great Britain was founded. This society oversaw the education and training of pharmacists to assure a scientific basis for the profession. Today professional societies around the world play a prominent role in supervising the education and practice of their members.
In 1783 the English physician and botanist William Withering published his famous monograph on the use of digitalis (an extract from the flowering purple foxglove, Digitalis purpurea). His book, An Account of the Foxglove and Some of Its Medicinal Uses: With Practical Remarks on Dropsy and Other Diseases, described in detail the use of digitalis preparations and included suggestions as to how their toxicity might be reduced. Plants containing digitalis-like compounds had been employed by ancient Egyptians thousands of years earlier, but their use had been erratic. Withering believed that the primary action of digitalis was on the kidney, thereby preventing dropsy (edema). Later, when it was discovered that water was transported in the circulation with blood, it was found that the primary action of digitalis was to improve cardiac performance, with the reduction in edema resulting from improved cardiovascular function. Nevertheless, the observations in Withering’s monograph led to a more rational and scientifically based use of digitalis and eventually other drugs.

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