Pharmaceutics in the context of "Biologic medical product"

⭐ In the context of biopharmaceuticals, what fundamentally differentiates these products from traditionally synthesized pharmaceuticals?




⭐ Core Definition: Pharmaceutics

Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or an existing drug into a medication to be used safely and effectively by patients. The patients could be either humans or animals. Pharmaceutics helps relate the formulation of drugs to their delivery and disposition in the body. Pharmaceutics deals with the formulation of a pure drug substance into a dosage form.

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👉 Pharmaceutics in the context of Biologic medical product

A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biopharmaceuticals can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine.

Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. The term biologics is often used more restrictively to mean biopharmaceuticals that are produced using recombinant DNA technology. Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid-based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source. Biopharmaceutics is pharmaceutics that works with biopharmaceuticals. Biopharmacology is the branch of pharmacology that studies biopharmaceuticals. Specialty drugs, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. The European Medicines Agency uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are "based on genes, cells, or tissue engineering", including gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines, and combinations thereof. Within EMA contexts, the term advanced therapies refers specifically to ATMPs, although that term is rather nonspecific outside those contexts.

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In this Dossier

Pharmaceutics in the context of Factory farming

Intensive animal farming, industrial livestock production, and macro-farms, also known as factory farming, is a type of intensive agriculture used by the meat and dairy industry to maximize animal production while minimizing costs. To achieve this, agribusinesses keep livestock such as cattle, poultry, and fish at high stocking densities, at large scale, and using modern machinery, biotechnology, and pharmaceutics. The main products are meat, milk and eggs for human consumption.

While intensive animal farming can produce large amounts of animal products at a low cost with reduced human labor, it is controversial as it raises several ethical concerns, including animal welfare issues (confinement, mutilations, stress-induced aggression, breeding complications), harm to the environment and wildlife (greenhouse gases, deforestation, eutrophication), increased use of cropland to produce animal feed, public health risks (zoonotic diseases, pandemic risks, antibiotic resistance), and worker exploitation, particularly of undocumented workers. The animal agriculture industry has been accused of actively supporting disinformation campaigns and preventing policies to address climate change.

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Pharmaceutics in the context of Prototype drug

In pharmacology and pharmaceutics, a prototype drug is an individual drug that represents a drug class – group of medications having similar chemical structures, mechanism of action and mode of action. Prototypes are the most important, and typically the first developed drugs within the class, and are used as a reference to which all other drugs are compared.

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Pharmaceutics in the context of GlaxoSmithKline

GSK plc (an abbreviation of its former name GlaxoSmithKline plc) is a British multinational pharmaceutical and biotechnology company. It was established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham, which was itself a merger of a number of pharmaceutical companies around the Smith, Kline & French firm. It is headquartered in London, England.

GSK is the tenth-largest pharmaceutical company and No. 294 on the 2022 Fortune Global 500, ranked behind other pharmaceutical companies China Resources, Sinopharm, Johnson & Johnson, Pfizer, Roche, AbbVie, Novartis, Bayer, and Merck Sharp & Dohme.

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Pharmaceutics in the context of Pharmaceutical formulation

Pharmaceutical formulation, in pharmaceutics, is the process in which the active drug or Active Pharmaceutical Ingredient (API) is combined with different chemical substances to produce a final medicinal product. The word formulation is often used in a way that includes dosage form.

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Pharmaceutics in the context of Cream (pharmaceutical)

A cream is a preparation usually for application to the skin. Creams for application to mucous membranes such as those of the rectum or vagina are also used. Creams may be considered pharmaceutical products, since even cosmetic creams are manufactured using techniques developed by pharmacy and unmedicated creams are highly used in a variety of skin conditions (dermatoses). The use of the finger tip unit concept may be helpful in guiding how much topical cream is required to cover different areas.

Creams are semi-solid emulsions of oil and water. They are divided into two types: oil-in-water (O/W) creams which are composed of small droplets of oil dispersed in a continuous water phase, and water-in-oil (W/O) creams which are composed of small droplets of water dispersed in a continuous oily phase. Oil-in-water creams are more comfortable and cosmetically acceptable as they are less greasy and more easily washed off using water. Water-in-oil creams are more difficult to handle but many drugs which are incorporated into creams are hydrophobic and will be released more readily from a water-in-oil cream than an oil-in-water cream. Water-in-oil creams are also more moisturising as they provide an oily barrier which reduces water loss from the stratum corneum, the outermost layer of the skin.

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