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New drug developing process




The drug manufacturing industry has produced a variety of medicinal and other health-related products undreamed of by even the most imaginative apothecaries of the past. These drugs have saved the lives of millions of people from various diseases, and they permit many ill people to lead reasonably normal lives. Thousands of medications are available today for diagnostic, preventive, and therapeutic uses. These medicines aid in the control of venereal disease, tuberculosis, influenza, cardiovascular disease, malaria, pneumonia, diabetes, some forms of cancer, etc.

The drug industry is comprised of establishments that make pharmaceutical preparations or finished drugs; biological products, such as serums and vaccines; bulk chemicals and botanicals used in making finished drugs; and diagnostic substances such as pregnancy and blood glucose kits.

Now letТs see the stages of a drug production process. The first step in this lengthy process begins with scientific research to discover new products, and to improve or modify existing ones. The main task of this stage is to identify a possibly useful compound which has the potential to prevent, combat, or alleviate symptoms of diseases or other health problems.

If the discovery phase yields promising compounds, technical teams then attempt to develop a safe and effective product based on the discoveries. For testing new products in development, a research method called "screening" is used. Each year, researchers study the effects of potential new medicines on millions of animals, including mice, rats and chickens for evidence of useful and harmful effects. A new drug is selected for testing in humans only if it promises to have therapeutic advantages over drugs already in use, or if it offers the possibility of having fewer side effects. After laboratory screening, firms conduct clinical investigations, or "trials," of the drug on human patients.

Once these stages have been successfully concluded, the drug manufacturing company can submit an application for approval to the regulatory authorities. This application must contain the following information:

(1) Detailed reports of the preclinical (animal) studies;

(2) Reports of all clinical (human) studies;

(3) Information on the composition and manufacture of the drug and on the controls and facilities used in its manufacture;

(4) Samples of the drug and its labeling.

Only after the approval of the regulatory authorities, which means that the drug meets all the official standards of strength and purity, the manufacturing company is allowed to market this new drug.

 

Summary:The drug developing process is the process of bringing a new drug to the market which includes pre-clinical research (animals) and clinical trials (on humans) and may include the step of obtaining regulatory approval to market the drug.

Exercise 11: Answer the following questions:

1. Can you explain the importance of drug producing industry?

2. What is the drug industry comprised of?

3. Can you name the stages of a drug manufacturing process?

4. What is the main target of a scientific research?

5. How do you understand the term Уdevelopment of a drugФ?

6. What information does the approval to the regulatory authorities consist of?

7. What does the approval to the regulatory authorities mean?

8. How do you understand the term Уto market a new drugФ?

Exercise 12: Make your own short report about the process of drug production.

 

 

Exercise 13: You know that many English words are polysemantic. Can you find the right translation to the following idioms:

a bitter pill to swallow неходкий товар, товар, на который нет спроса; залежалый товар
I know I did wrong, and I know I have to take my medicine. препараты, улучшающие некоторые способности человека (такие как пам€ть, внимание, концентраци€ и т.д.)
a drug in the market я знаю, что поступил неправильно и что мне нужно примиритьс€ с неизбежным.
Jim was always playing tricks on other boys. Finally they decided to give him a dose of his own medicine. проглотить горькую пилюлю
smart drugs ƒжим всегда подшучивал над реб€тами. ¬ конце концов, они решили отплатить ему той же монетой.

 

 
 

 


 

 

Exercise 14:

Listen to the tape http://www.youtube.com/watch?v=bosxbO-hw9c and:

1. Try to tell in Russian the main idea of the text;

2. What new information have you learnt from honorary associate professor Louis Roller?

3. Can you explain to your groupmates the difference between Biopharmaceutics, Pharmacokinetics and Pharmacodynamics?

4. What is a therapeutic range?

5. Can you explain what happens to the medicine when it is swallowed by a patient?


Exercise 15: Work with text according to the following algorithm:

1. Read the title of the text and tell how you understand it?

2. Try to guess what this text is going to be about.

3. Look through the text and underline the informative words and phrases.

4. Read the text and find the words and word-combinations with the following meanings: 1) the official power to make legal decisions and judgments; 2) a physician or a surgeon; 3) to make up and give out medicine according to a doctor's prescription (usually at the chemistТs).

5. Read and divide it into logical parts. Think of title to each of them.

6. Look through the text once again and compose the plan of the text.

7. Make a structural and semantic scheme of the text according to the following points:

a) The aim of the text

b) The context elements: main elements and secondary elements

8. Ask your groupmates some questions according to the text.

9. Prepare an annotation of this text.

 

THE ENGLISH PRESCRIPTION

A prescription (℞) is a health-care program fulfilled by a physician or other medical doctors in the form of instructions that contain the plan of care for an individual patient. Prescriptions are handwritten on preprinted prescription forms that identify the document as a prescription, the name and address of the prescribing provider and any other legal requirement such as a registration number.

℞ is a symbol meaning "prescription". It originated in medieval manuscripts as an abbreviation of the Late Latin verb recipe, the imperative form of recipere, "to take" or "take thus". Literally, the Latin word recipe means simply "Take Е" and medieval prescriptions invariably began with the command to "take" certain materials and compound them in specified ways. Today, when a medical practitioner writes a prescription beginning with "℞", he or she is completing the command.

Both pharmacists and prescribers are regulated professions in most jurisdictions. A prescription as a communications mechanism between them is also regulated and is a legal document.

Regulations may define what constitutes a prescription, the contents and format of the prescription and how prescriptions are handled and stored by the pharmacist.

Some prescriptions will specify whether and how many "repeats" or "refills" are allowed; that is whether the patient may obtain more of the same medication without getting a new prescription from the medical practitioner.

When filled by a pharmacist, he may write some additional information right on the prescription, such as the actual manufacturer of the drug and the date the medication was dispensed. Legislation may also require the pharmacist sign the prescription.

When filled by the pharmacist, prescriptions are typically assigned a "prescription number" that is written right on the prescription. The prescription number has the practical purpose of identifying the prescription later on while filed. The prescription number is also put on the label on the dispensed medication. The patient may be required to reference the prescription number for refills and drug insurance claims. There may also be a legal requirement for prescription numbers for subsequent identification purposes.

As a legal document, some jurisdictions may require the archiving of the original paper prescription in the pharmacy. Often the patient cannot take the original prescription with them. Some jurisdictions may give patients a copy. The retention period varies but can be as long as 10 years. Once the retention period has passed, privacy legislation may dictate what can be done with the original paper prescription. Legislation may also dictate what happens to the prescriptions if the pharmacy closes or is sold.

 

 

 

 


Unlike an essay, a report has a formalized structure. The sections of a scientific report are:

1) Title. The title of the report should be short and informative. It should not be indefinite and general, but should reflect the essence of the research. The title should be no longer than 15 words. It is generally given on a separate page together with the name of the researcher, course and instructor details.

2) Abstract. The abstract is a precise summary of the whole report. Its function is to preview the contents of your report so that the reader can judge whether it is worth their while to read the whole report.

3) Introduction. In your introduction, you need to let the readers and markers of the report know why the report is important and what exactly the report is about.

4) Method. The purpose of this section is to exactly describe method and materials used to carry out the experiment with enough detail so someone else could repeat the same procedure.

5) Results. This section describes but does not explain your results; it provides the reader with a factual account of your findings.

6) Discussion. This section has two fundamental aims: to explain the results of the study and to explore the significance of the studyТs findings.

7) Reference list or bibliography. A bibliography is a list of all the reference material the researcher consulted during his research for the report while a reference list is a list of all the references cited in the text of the report, listed in alphabetical order at the end of the report. Each reference in the reference list needs to contain all of the bibliographic information from a source.

8) Appendices. Information that is not essential to explain the researcherТs findings, but that supports his analysis (especially repetitive or lengthy information), confirms his conclusions or pursues a related point should be placed in an appendix.

 

Exercise 16: Here are some cliché to write a scientific report. Translate them into Russian and state to what part of the report they can refer:

  1) Title 2) Abstract 3) Introduction 4) Method 5) Results 6) Discussion 7) Reference list 8) Appendices ¨ As the title implies the article describes Е ¨ A mention should be made about Е ¨ From the results it is concluded that Е ¨ The following conclusions are drawn Е ¨ The purpose of the research is to prove (test, develop, summarize, find) Е ¨ This method is now generally accepted Е ¨ There is some interesting information in the paper Е ¨ It is impossible to account for Е ¨ It draws our attention toЕ ¨ Much attention is given toЕ ¨ Some factors are taken into account Е ¨ Thus, a general conclusion is made concerning Е ¨ This method is now generally accepted Е ¨ The article under discussion aims to explain Е ¨ The measurements (calculations) are made Е ¨ It is necessary to introduce Е ¨ The author refers to Е ¨ There are several solutions of the problem Е

Exercise 17: Before translation make a back-ground analysis: Quincke, MAO.

 

Exercise 18: Before translation study the theory of translation Ц comparative analysis.

¬ажным методом исследовани€ в лингвистике перевода служит сопоставительный анализ перевода, т.е. анализ формы и содержани€ текста перевода в сопоставлении с формой и содержанием оригинала. Ёти тексты представл€ют собой объективные факты, доступные наблюдению и анализу. “аким образом, в процессе перевода устанавливаютс€ определенные отношени€ между двум€ текстами на разных €зыках (текстом оригинала и текстом перевода). —опоставл€€ такие тексты, можно раскрыть внутренний механизм перевода, вы€вить эквивалентные единицы, а также обнаружить изменени€ формы и содержани€, происход€щие при замене единицы оригинала эквивалентной ей единицей текста перевода. —опоставительный анализ переводов дает возможность вы€снить, как преодолеваютс€ типовые трудности перевода, св€занные со спецификой каждого из €зыков, а также какие элементы оригинала остаютс€ непереданными в переводе.

—опоставительное изучение переводов дает возможность получать информацию о взаимосв€зи отдельных элементов оригинала и перевода, обусловленной как отношени€ми между €зыками, участвующими в переводе, так и внелингвистическими факторами, оказывающими вли€ние на ход переводческого процесса.

Exercise 19: Read the annotation to the medicinal preparation SuprastinЃ and translate it into Russian. Carry out comparative analyses of original annotation and its translation into Russian.

SUPRASTINEЃ

Drug name: SuprastinЃ (chloropyramine)   Therapeutic effects: SuprastinЃ is a histamine H1-receptor antagonist, a derivative of ethylenediamine. Its main component, chloropyramine, prevents the development of allergic reactions and facilitates their course. SuprastinЃ has a moderate sedative effect and a marked antipruritic property. It possesses antiemetic effect, peripheral anticholinergic activity, and moderate inflammatory properties.   Indications: Ј hives; Ј angioedema (QuinckeТs edema); Ј serum sickness; Ј seasonal and perennial allergic rhinitis; Ј conjunctivitis; Ј contact dermatitis; Ј skin itching; Ј acute and chronic eczema; Ј atopic dermatitis; Ј food and drug allergies; Ј allergic reactions to insect stings.   Side Effects: Ј CNS: drowsiness, fatigue, dizziness, agitation, tremor, headache, euphoria. Ј Gastrointestinal tract: abdominal discomfort, dry mouth, nausea, vomiting, diarrhea, constipation, appetite disorders, pain in the upper abdomen. Ј Cardiovascular system: decreased blood pressure, tachycardia, arrhythmia. Ј Other: difficulty urinating, muscle weakness, increased intraocular pressure, photosensitivity.   Drug interactions: SuprastinЃ should not be used with the following drugs: Ј sedatives, tranquillizers; Ј analgesics; Ј MAO inhibitors; Ј tricyclic antidepressants; Ј sympatholytics; Ј atropine.   Cautions and restrictions: SuprastinЃ should not be used in the following conditions: Ј hypersensitivity; Ј acute attack of asthma; Ј newborns; Ј pregnancy, breastfeeding.   Use SuprastinЃ with caution in: Ј angle-closure glaucoma; Ј urinary retention; Ј prostatic hyperplasia; Ј liver and / or kidneys dysfunction; Ј cardiovascular diseases; Ј elderly patints.   Additional information: The drug should be stored in a place inaccessible to children at a temperature 15 to 25 C. Shelf life - 5 years.  

 

Exercise 20: Work with a group - Answer the questions:





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