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Agriculture is very important branch of economy for the majority of developing countries. Production of the agricultural products is the main source of currency for developing countries and currency is necessary for buying some machines and equipment for development of agriculture. It is like a circle. That is why we all know about very difficult situation with food in developing countries. Acute food crisis in develo

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ping countries (for example in African or Latin America countries) continues to threaten the population. Scientists say that malnutrition has very negative results for physical and mental state of the people. Malnutrition can reduce resistance diseases and it raises infant mortality. About 100 thousands children lose their sight because of the shortage of A – vitamin. When in such conditions family has more than one c

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ild (it is usual situation for developing countries) as a result we can see the raise of infant mortality. 63% of the Peruvian families can not earn enough money for rational food.

If we look at the situation during some years, we will see some improvements in countries of Latin America and Near East, but the situation is getting worse in African countries. Today, infant mortality in developing countries is 6-17 tim

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

s higher than in developed ones. UN data show that only in 1989 more than 500 thousands children died of starvation.

There are a lot of reasons of starvation in developing countries. It is very interesting that in some countries of Africa and South Asia women and children are not allowed to eat with men. First of all, men eat and than women and children, you can imagine what is left after men. Then, of course, it

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

s drought. We can imagine events like a chain: drought leads to starvation, starvation leads to many problems: people leave their villages and go to the cities, but cities have not necessary structure and enough amount of working places (increase of unemployment), besides, we can see increase of emigration. And there is a problem of demographic situation. Increment of population is too quick. There is no such amount o

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

food to feed so many people. That is why governments of the developing countries try to introduce a policy of birth-rate control.

There is a question, why people die of starvation if they have so comfortable nature and climatic conditions. The major part of the “Third World” countries is, so called, Best Land. It is always very warm in tropics, there is a lot of sunshine, humidity, there are huge agrarian tracts, wa

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

m seas and a great amount of lakes. But the real situation is not so perfect. The climate is very unpredictable, rains fall only during one season of the year, they lead to floods. During the other seasons of the year sun dries up the ground and plants and if there is no watering, it will be very small harvest. The hard winds lead to erosion of soil. A real tragedy for tropic Africa is the fly, which does not allow to

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

breed cattle. Typhoons and tsunami cause a great damage to agriculture. The major part of the territory consists of deserts, mountains, jungle, marshes and of other lands, which can not be used in agricultural purposes. And as for the water resources, developing countries have less water than developed ones.

Now developed countries think about the economical development of the “Third World” countries. They try to pre

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ipitate this process of the development with the help of capital investments. Foreign countries are not satisfied with agricultural and raw material specialization of developing countries, very low level of cultivation industry, very narrow inner market, because they are interesting in the sale of their goods. Foreign companies invest their capitals in the cultivation industry. These capitals are given to the develop

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ng countries on very suitable terms as for the terms of redemption, discount rate and so on. The international companies control the great part of export goods. They hold very strong position in economy of different developing countries. There are more than 30 thousands branches (offices of foreign companies in the developing countries, more than 20 thousands of American offices, more than 6 thousands of English offic

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

s, more than 3 thousands of Japanese offices.

Competing one with another about the attraction of the foreign capitals, developing countries have to give the great privileges to the foreign companies, different discounts, which connected with the taxation, income, limitation of import goods, terms and others. Foreign countries facilitate the usage of the natural resources, help to raise the government capital, export,

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

employment. The relationship of the foreign capital with the economy of the developing countries is not perfect. On the one hand, all relations in the economical sector are conducted by the development of the world economy. Foreign companies are more technically developed and they have more opportunities for investments than national companies.

On the other hand, foreign companies are alien to the developing countr

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

es economy, they are orientated more towards the foreign (outside) market than towards the inner market. Foreign capital influences on the agricultural development of the ‘Third World’ countries in different ways. It participates in fund making that facilitates the raise of the industry. With the help of the foreign capital in developing countries were made different industrial companies, oil-processing companies. For

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ign capital helps to the local businesses, financially and technically. Also foreign investments facilitate the development of commodity-money relations that stimulates development of the good production.

In the majority of cases foreign investments are attracted to those branches of economy, where developing countries can not do anything it selves. The usual form of the legal regulation of the foreign investments i

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

the investment’s codes, they consist of different points about different forms of income, discounts, percentage and others. Foreign companies, which have some business activities in the young developing countries, get higher income from their investments.

Now I would like to say some words about the traditional family structure. During 70-s the birth-rate level in developing countries was more than two times highe

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

than in developed countries. The reasons of so high birth-rate are in social and economical conditions. We can name some factors, which can facilitate the tendency of having many children, first of all, it is a high infant mortality, early marriages, a strong desire of parents to ensure their old age. Scientists consider that raise of marriage age will facilitate the birth-rate reduce. There are different governmen

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

programs about this problem in some countries. The religious traditions and customs facilitate the high birth-rate. For example, Moslemism make people to have many children, to get married very early, to have a lot of wives, it forbids people to live without wife and children.

There are different tribal religions, which are connected with cult of ancestors, they also facilitate having a lot of children, they blame s

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ngle men and unmarried women. Now, we can see, that the religious traditions are getting weaker, the reasons of this process are development of education, urbanization and others, but still the religious traditions influence very hard on the people psychology, especially in the birth-rate. The high birth-rate in the developing countries also is connected with very low social position of woman in society and in family.

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

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There are different programs of the family planning and of the family reduction of the birth-rate. In some countries, for example, in India, Egypt, Brazil, measures of the birth-rate control are declared the government

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

policy. There are different social and economical measures in different countries, they include financial assignation for the birth-rate control programs. The government efforts and different non-government organizations efforts, which try to reduce the high birth-rate, face difficulties connected with the archaic relations in the society, with very strong influence of religion and with the poverty of the population

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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