l. The bulk minerals contain zinc, iron, copper, and other elements, and trace minerals include calcium, sodium, magnesium, etc.
2. There is a possibility of overdosing minerals, if they are taken in excessive amounts.
3. Most specialists insist that minerals should not be taken in chelated forms.
4. The intake of minerals should be balanced because they compete for absorption in the body.
5. Calcium works better when taken in a single megadose.
6. Calcium supplements are not for those who have kidney diseases.
7. Iodine deficiency is linked with hypothyroidism and breast cancer.
VI.Домашнее задание к следующему занятию.
1. Повторить грамматический материал занятия 14.
2. Выучить лексику по теме «Minerals».
VII. Контроль.
Устный опрос.
Список основной литературы
- Английский язык [Электронный ресурс]: учебник / Т. В. Евсюкова, С. Локтева, С. Локтева. - М.: ФЛИНТА; МПСИ, 2011. - 358 с.
- Английский язык для медиков [Электронный ресурс]: учебное пособие / М. С. Муравейская, Л. К. Орлова. - 11-е изд. - М.: ФЛИНТА, 2011. - 384 с.
- Английский язык для медицинских колледжей и училищ: учебное пособие для обучающихся медицинских училищ и колледжей / Л. Г. Козырева, Т. В. Шадская. - 16-е стереотип. - Ростов н/Д: Феникс, 2014. - 316 с.
Список дополнительной литературы
- Английский язык [Электронный ресурс]: сб. тестовых заданий с эталонами ответов для обучающихся 1-2 курсов, обучающихся по спец. 060108 – Фармация (очная и заочная форма обучения) / сост. Л. Г. Носова, Г. В. Юрчук, О. А. Гаврилюк [и др.]; Красноярский медицинский университет. - Красноярск: КрасГМУ, 2011. - 185 с.
- Английский язык [Электронный ресурс]: учеб. пособие по развитию устной речи "Hello, doctor!" / Н. В. Платонова, Л. Г. Носова, Г. В. Юрчук; Красноярский медицинский университет. - Красноярск: КрасГМУ, 2011. - 56 с.
- Англо-русский медицинский словарь: учебное пособие / ред. И. Ю. Марковина [и др.]. - М.: ГЭОТАР-Медиа, 2013. - 496 с.
Английский язык [Электронный ресурс]: учебно-методическое пособие по практике устной и письменной речи для 1 курса неязыковых фак. / сост. К.. Самтакова, Н.. Майер. - Горно-Алтайск: Горно-Алтайский гос. ун-т, 2010. - 200 с.
РАЗДЕЛ 6. «Фармацевтические препараты»
Практическое занятие № 15
Грамматическая тема: отрицательные суффиксы и приставки
Лексическая тема: Drug product development
Тематика занятия
Отрицательные суффиксы и приставки.
I Вопросы для обсуждения:
1. Словообразование: с помощью отрицательных суффиксов и префиксов.
2. Лексический минимум по теме «Drug product development».
3.Чтение и обсуждение текста.
II Выполнение заданий по теме
Образуйте от этих слов слова с противоположным значение с помощью приставок un-, in-, dis-, im-, in-, ir-.
accurate, regular, common, advantage, miscible, soluble, pleasant, sufficient, compatible, equal, complete, stable, correct
2. Прочитайте и переведите следующие слова с суффиксом –less:
Sleepless, careless, helpless, homeless, lifeless, painless, hopeless, restless
III Лексический минимум по теме «Drug product development»
| 1. pharmaceuticals 2. to affect 3. a wide variety of 4. an active pharmaceutical ingredient (the API) 5. an inert ingredient 6. the vehicle 7. a formulation matrix 8. to comprise 9. enzymatic 10. recombinant DNA technology 11. pure, purification 12. a drug product 13. in association with 14. an excipient 15. an entity 16. development | 17. efficacy 18. to submit an application 19. healthy volunteers 20. drug tolerance 21. under close supervision 22. dose-response studies 23. to perform 24. dosage regimen 25. the therapeutic index 26. large-scale 27. to monitor 28. to occur 29. review 30. to grant market approval 31. batch 32. approve, approval |
IV Базовый текст
Прочитайте и переведите текст
Drug product development
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, hypnotics, antidepressants, analgesics, narcotics, anesthetics, and a wide variety of preparations for specific purposes, such as laxitives, 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.
V.Вопросы для обсуждения.
