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If you’re setting up a country, who would you like to govern it? Would you like a secular country or one basically controlled by a particular religion? By secular I mean one who allows all religi

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

ons freedom to practice their own faith without infringing upon the rights of others to practice theirs, but at the same time controlling or governing the earthly part of their lives.

To begin with

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

Examples of combination products may in

one has to examine the various countries around the world and to see how they’re governed. Most countries are secular in nature, but there are a number of countries controlled or at least greatly

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

influenced by a particular religion. Those countries controlled or greatly influenced by a religion are mostly Islamic. They are Iran, Syria, Iraq, Afghanistan, Indonesia, Pakistan, Palestine an

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

d a number of others. And of course there is always Israel which is controlled by the Jews. But in the past you also had the Roman Catholic Church controlling many countries. Today they’re still

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

Combination pro

trying, but their influence has been greatly diminished. I might add here that in some of these Islamic countries, there still seems to be a great struggle going on between secularism and Islam as

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

to who should really govern.

Now the biggest conflict in the world today is between countries governed or greatly influenced by a particular religion. They are basically the Islamic States and th

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

e Jewish state, Israel. Now as an aside, what has caused this conflict? I believe it basically started right after the Second World War when the victorious allies set up the State of Israel right

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

on top of some Islamic or Palestinian lands. This meant that many of the Palestines had to move from their homeland to another place. Of course this has angered many of the Islamic peoples and thi

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

s conflict has been going on ever since. Now why did these victorious allies do this? Well there were several reasons for this. One reason is that the victorious allies felt very guilty about the

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

Holocaust which they failed to prevent during the war, so they felt they had to give the Jews a homeland where they could feel safe. After all the Jews have always been persecuted throughout the cen

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

Following aspects would a

turies for one reason or another, and this could provide a safe haven for them. But one might ask, why this particular land? That is, because the Jews believe that this is the land that God origina

dd to the challenges in developing combination products:

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

lly gave them, and the Christians, which make up most of the victorious allies, knew their faith originated from here, and therefore found a common bondage with the Jews in establishing a new homela

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

nd in this particular locality. Of course, today from a Christian perspective, we feel the new homeland or Kingdom of God should be found in a person’s heart, regardless of where they lived.

Now g

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

etting back to the main theme of this article, I believe that the prime problem concerning this is that those countries that are more secular seem to be more successful in providing their people wit

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

h a better standard of living. Why is this? I believe it is because if a country is controlled by a particular religion or is greatly influenced by one, it tends to control freedom of thought to

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

Professional from academic institutions, pharmaceutical industries, health care indust

a great extent. And when a country tends to control freedom of thought, it tends to limit access to new ideas on how to improve upon one’s life. This is what happened in the past when the Roman Cat

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

holic Church controlled so many countries. Those countries that were controlled by the Roman Catholic Church did not progress as fast as those countries which basically had a secular form of governm

.

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

ent. For example, look at the difference between Latin America and the United States. Now today the same thing probably could happen to those countries that are insisting that they become Islamic

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

Companies that provide selfless information through particip

, or are insisting that they be guided by any other particular religion This same reasoning in controlling freedom of thought can be applied to those countries that tend to be authoritarian as well

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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Law enforcement agencies employ a number of different field sobriety tests to determine enough probable cause to make an arrest for drunk driving. The National Highway Traffic and Safety Administration (NHTSA) has conducted studies which have determined that some tests are accurate indicators, to a degree, of a blood alcohol content (BAC) above .10%. However, law enforcement agencies often use non-scientific tests, or non-standardized field sobriety tests, to determine intoxication.

This article describes the highlights of living in the progressive arts town of Saugatuck, Michigan.

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