May 2, 2023

What is Drug or Pharmaceutical:

Pharmaceutical or a drug is a substance may be derived from botanical, herb, and their exudates, roots, etc., may be derived from mineral, metal and their oxides, chelates, synthesized in laboratory from pure organic or inorganic chemicals as procures and purified later on to use as pharmaceutical or drug. May be derived from biological, animal, insects, bacteria, and viruses, and vector viruses may be genetically engineered, synthesized from bacterial and fungal growth and their exotoxins, endo toxins.

Pharmaceutical Manufacturing

Examples of the pharmaceuticals derived from Plant:

Quinine is a drug derived from cinchona tree bark, it is still one of drug which is used to treat malaria.
Many people say that the herbal medicines do not pose any side effect, this statement is wrong, there should be limitation for use of herbal drug too, since the compounds found in herbs also pose serious side effects pharmacologically.
For example, the tobacco is derived from herb, Opium, is derived from plant, but are most toxic in nature. So the statement on herbal drug that they are safe and do not pose any side effects is wrong, since the many herbal drugs are not evaluated in clinical trial. Since they are used since ancient times therefore they have default approvals to use them as pharmaceutical and drug.

Examples of the pharmaceuticals derived from metal and their oxides: Aluminum hydroxide, Magnesium Hydroxide.

Examples of the pharmaceuticals derived from metal and their metal: Lithium Carbonate used as anti-depressant. Ferrous Gluconate used in Anemia.
Examples of the pharmaceuticals derived from insects: Anti bodies to treat Scorpion sting are derived by injecting scorpion venom in to horse, and horse serum is purified to obtain antibodies to treat scorpion sting.
Examples of the pharmaceuticals derived from synthesized in laboratory from pure organic or inorganic chemicals: Paracetamol.
Examples of the pharmaceuticals synthesized in laboratory from Biological Source: Antibiotics
Examples of the pharmaceuticals derived from Bacteria: Live bacterial pharmaceutical, lactobacillus
Examples of the pharmaceuticals derived from Viruses: Polio Vaccine, contains live and attenuated polio Virus.
Examples of the pharmaceuticals derived from Virus vector: Gene therapy drug delivery systems are based on virus vector that carries gen to be inserted in human, these virus vector get located in the spot and deliver the gen.
Examples of the pharmaceuticals genetically engineered: Insulin, human Insulin and other hormones.

Pharmaceutical and drug approval process:
Any company willing to manufacture and sale Drug and pharmaceuticals have to get a sales and manufacturing license in that country, in USA USFDA regulate the manufacturing and sale of the pharmaceuticals. In India, CIDISCO, in UK MHRA, Australia TGA, and so on their Nigeria NAFDAC and WHO issues certificate to pharmaceutical or drug as pharmaceutical product.

How a substance gain status as pharmaceutical and Drug?

A substance is studied for the effect, then safety and then efficacy in the clinical trials, then the substance is approved by Food and drugs administrations.
First a substance is required to study in animal model for its effect and safety, teratogenicity. Then in phase to it is studied in small group of human volunteers for safety, and in phase three it is studied in large population of human volunteers.

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5 thoughts on “Pharmaceutical”
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  2. […] of reviewing the application for thalidomide’s approval. Despite mounting pressure from the pharmaceutical company and her superiors to expedite the process, Dr. Kelsey remained steadfast in her commitment […]

  3. […] including embolism. To safeguard patient safety and maintain the highest quality standards in pharmaceutical manufacturing, the United States Pharmacopeia (USP) has established specific limits for particulate […]

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