The names of pharmaceuticals

Pharmaceutical industry is filled with names - technical, proprietary, non-proprietary, official, and unofficial. These names serve many purposes, from identifying drug substances to promoting the reputation of a company. While this many names seems to be describing the same item, they are not synonyms, and have arisen from the legal and scientific nomenclature needs of the different segments of pharmaceutical industry.

The chemical name is applied to a specific chemical structure using the international nomenclature rules. These names provide a lot of information to the practising chemist, but are often long and complex, providing little information to health care professionals. The nonproprietary name is entirely the public domain, and may be used freely by anyone. Also known as the generic or common names, the official nonproprietary names are provided by national and international nomenclature bodies. In 1953, the member countries of the World Health Organization (the WHO) resolved to initiate the International Nonproprietary Name program. Since then, the activities of the national committees have been coordinated to achieve international standardization. The official name for a drug substance or drug product is usually found in the official pharmacopoeia of the country (e.g., the United States Pharmacopoeia.).

The established name is used for all legal matters that might pertain to an individual substance or product. It may be an official name recognized in an official compendium, an official title contained in the compendium, or the common (usual) name of the drug.

The proprietary name is owned by a company or manufacturer and is used to describe its brand of a particular product Proprietary names are developed, as part of a company’s intelectual property portfolio, including patents, licences, and copyrights. Also known as brand names, or tradenames, they may be registered with the trademark office of the country where the company sells its products. A tradename is a special category of proprietary name that specifies the name a company is doing business under. Although a tradename is often confused with trademark, the terms are not synonymous.

The United States Pharmacopoeia (USP) has suggested that PEN names (Proprietary Established Names) be developed as a convenience for prescribers and dispensers where it is impractical to write the entire compendial name for a product.

After patent expiration of the brand drug product, a generic drug product may be marketed. A generic drug product is therapeutically equivalent to the brand name of drug product and contains the same amount of the drug in the same type of dosage form. A generic drug product must be bioequivalent (i.e. have the same rate and extent of drug absorption as the brand drug product). Therefore, it is expected to have similar clinical response although it may differ from the brand product in physical appearance or in the amount and type of the excipients (only for tablets).

II.9. Найдите в тексте и переведите письменно предложения, содержащие:

а) случаи yпотребления сказуемого во временах Perfect Active и Passive;

б) неопределенные местоимения

II.10. Найдите в тексте ответы на следующие вопросы.

1. Where did all the different names of the pharmaceuticals come from?

2. What are the advantages and disadvantages of the chemical name?

3. How is international standardization in pharmaceutical nomenclature achieved?

4. What is the difference between the nonproprietary and proprietary names?

5. Is there any difference between the tradename and the brand name? Specify, please.

6. When are the generic drugs allowed to be marketed?

7. What requirements must the generic drug meet?

8. How may it differ from the brand drug product?

II.11. Ознакомьтесь со словами к тексту С.

II.12. Прочтите и переведите текст.

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