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 let’s 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 “development of a drug”?

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 “to market a new drug”?

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 память, внимание, концентрация и т.д.)
a drug in the market	Я знаю, что поступил неправильно и что мне нужно примириться 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	Джим всегда подшучивал над ребятами. В конце концов, они решили отплатить ему той же монетой.