Drug product development in the USA
Pharmaceuticals are medicinal drugs. A drug is any chemical substance that affects the functions of living things. Pharmaceuticals are used in treating, diagnosing, and preventing diseases. Commonly used types of pharmaceuticals include antibiotics, stimulants, tranquilizers, sedatives and hypnotics, antidepressants, analgesics, narcotics, anesthetics, hormones, and a wide variety of preparations for specific purposes, such as laxatives, heart stimulants, diuretics and antihistamines.
Generally, a drug consists of a drug substance, or an active drug ingredient, (the API) in association with inert non-drug ingredients. Together, they comprise the vehicle, or formulation matrix. The API may be produced by chemical synthesis, isolation from a natural product, enzymatic reaction, recombinant DNA technology, or a combination of these processes. Further purification of the API may be needed before it can be used in a drug product.
A drug product is the finished dosage form (e.g., capsule, tablet, ointment) that contains the API, generally in association with other excipients, or inert substances.
For the drug product containing new chemical entities, (i.e., drug substances with unknown clinical, toxicologic, pH, physical and chemical properties), several phases of product development should proceed before market approval.
First, there is a preclinical phase when animal pharmacology and toxicology data are obtained to determine the safety and efficacy of the drug. At this stage, an investigational new drug (IND) application for testing the drug on humans is submitted to the FDA.
After that, clinical testing takes place. It includes four phases of testing the drug on humans, beginning with healthy volunteers, and ending with a large patient population. Healthy volunteers are used in Phase I clinical studies to determine drug tolerance and toxicity. In Phase II, a limited number of the patients with the disease or condition for which the drug was developed are treated under close supervision of the specialists. Dose - response studies are performed in order to determine the optimum dosage regimen for treating the disease. Safety is measured by determining the therapeutic index (ratio of toxic dose to effective dose), and a final drug formulation is developed. In Phase III, large - scale, multicenter clinical studies are performed in order to determine the safety and efficacy of the drug in a large patient population. Side effects are monitored in a large patient population with acute and chronic conditions, new toxic effects may occur, that were not evident in previous phases of clinical trials. In this phase, a new drug application (NDA) is submitted for review and approval.
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After the FDA grants market approval of the drug, product development may continue. The drug product may be improved as a result of equipment, regulatory, supply, or market demands.
After the NDA is submitted and before approval to market the product is obtained from the FDA, manufacturing scale-up activities take place. Scale-up is an increase in the batch size from the experimental batch to the full-scale production batch size of the finished product.
II. 3. Составьте не менее 10 вопросов по содержанию текста.
II.4. Найдите в тексте английские эквиваленты следующих слов и выражений.
Часто используемые типы лекарств, лекарства специального назначения, активно действующее начало, инертные ингредиенты, вещество – носитель, выделение из натурального продукта, новое лекарственное вещество, новое экспериментальноe лекарственное средство, клинические испытания (два варианта), контролировать побочные эффекты, улучшать лекарственный продукт, наращивание размера партии (товара).
II. 5. Haпишите расшифровки следующиех сокращений по образцу:
DNA is deоxyribonucleic acid
FDA , API , NDA , DNA , RNA
II.6. Соедините в пары названия понятий и их дефиниции:
a drug substance a ratio of toxic dose to effect
a drug product a formulation matrix
a new chemical entity an active pharmaceutical ingredient
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a vehicle a finished dosage form
inert substances an inert solvent
inert substances
a clinical trial excipients
a therapeutic index clinical testing
II.7. Oзнакомьтесь со словами к тексту В.
| proprietary name [prә ́ praiәtәri] | – | патентованное название |
| official name [ә ́fi∫әl] | – | фармакопейное название |
| to identify [ai ́dentifai] | – | идентифицировать |
| to promote [prә ́mout] | – | содействовать продаже товаров компании |
| to be applied [ә ́́ plaid] | – | применяться |
| nomenclature rules [nә ́menklәt∫ә] | – | правила номенклатуры |
| to provide [prә ́vaid] | – | давать, обеспечивать |
| public domain [ ́pʌblik dә ́ mein] | – | достояние общественности |
| generic name [ʤә ́ nerik] | – | родовое название |
| nomenclature bodies | – | номенклатурные органы |
| the member countries | – | страны – члены |
| the World Health Organization (the WHO) | – | Всемирная организация здравоохранения (ВОЗ) |
| to resolve [ri ́ zɔlv] | – | решать проблему |
| the established name | – | официальное название |
| legal matters [li:ɡәl ́ mætәz] | – | юридические вопросы |
| brand [brænd] | – | бренд, разновидность товара |
| intellectual property portfolio [PprOp@tI] [pɔ:t ́ fouliou] | – | интеллектуальная собственность компании |
| copyright [ ́kɔpirait] | – | авторское право |
| brand name, a tradename | – | фирменное, (коммерческое) название |
| trademark [ ́ treidma:k] | – | фирменный знак |
| a proprietary established name (PEN name) | – | официальное фирменное название |
| a compendial name [kәḿ pendiәl] | – | каталоговое название |
| to expire, expiration [eks ́́paiә] | – | истекать, истечение (срока) |
| equivalent [i ́ kwivәlәnt] | – | эквивалентный |
| bioequivalent [baioui ́ ́kwivәlәt] | – | биоэквивалентный |
| rate [reit] | – | скорость |
| extent [ikś́ ́tent] | – | степень |
| response [ris ́ pɔns] | – | реакция на (внешнее воздействие) |
| physical appearance [ ́ fizikәl ә ́́́́ piәrәns] | внешний вид | |
| qualitative composition [ ́ kwɔlitәtiv] | – | качественный состав |
| quantitative composition [ ́ kwɔntitәtiv] | – | количественный состав |
| unless [ʌ ́nles] | – | если не |
II.8. Прочтите текст В и составьте диаграмму, отражающую номенклатурное разнообразие лекарственных названий.
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Text В
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.
| route of administration [ru:t] | – | путь введения лекарства |
| site [ ́sait] | – | место, участок |
| topical, topically | – | местный, местно, наружно |
| antifungal agents [ænti ́fʌŋgәl] | – | противогрибковые препараты |
| to minimize [ ́minimaiz] | – | минимизировать |
| systemic absorption [sis ́temik әb ́sɔ:p∫n] | – | всасывание в системное кровоообращение |
| to consider [kәn ́sidә] | – | учитывать |
| intravenously, IV [intrә ́vi:nәsli] | – | внутривенно |
| to desire, desired [di ́zaiә] | – | желать, желаемый |
| immediate release [i ́mi:dIIt ri ́li:s] | – | немедленного действия |
| controlled release [k@n ́trould] | – | замедленного действия |
| parenteral [pә ́rentәrәl] | – | парентеральный |
| intra-arterial injection [intrәa: ́ti:riәl] | – | внутриартериальная иньекция |
| intramuscular, IM [intrә ́mʌskjulә] | – | внутримышечный |
| subcutaneous, SC [sʌbkju: ́teiniәs] | – | подкожный |
| intra-articular [ِ intrәa: ́tikjulә] | – | внутрисуставной |
| a joint [ ́ʤɔint] | – | сустав |
| intratechal [ ِ intrә ́tekәl] | – | в спинной мозг – интратекально |
| enteral [ ́entәrәl] | – | энтеральный |
| buccal [ ́ bʌkәl] | – | за щеку |
| sublingual [sʌb ́liŋɡwәl] | – | под язык |
| to bypass [bai ́pa:s] | – | миновать, пойти в обход |
| to swallow [ ́swɔlәu] | – | проглотить |
| the gastrointestinal tract [ِ gæstrәin ́testinәl] | – | желудочно – кишечный тракт |
| соnvenient [kәn ́vi:niәnt] | – | удобный |
| enema [i ́ni:mә] | – | клизма |
| mucosa [mju: ́kouzә] | – | слизистая оболочка |
| 28. intranasal [intrә ́neizәl] | – | внутриносовой |
| 29. to inhale, inhalation [In ́heIl] | – | вдыхать, ингаляция |
| 30. nebulizer [ِnebju: ́laizә] | – | ингалятор |
| 31. transdermal [trәns ́dә:mәl] | – | через кожу |
| 32. a patch [ ́pæt∫] | – | лечебная салфетка |
| 33. occlusive dressing /f ilm [ә ́klu:siv ́dresiŋ] | – | окклюзивная повязка, пленка |
II.12. Прочтите и переведите текст.
Text C
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