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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.

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

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.

II.8. Прочтите текст В и составьте диаграмму, отражающую номенклатурное разнообразие лекарственных названий.

Text В