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At the G8 conference in Germany, some 16 000 police have been deployed to control an estimated 6 000 protesters. Police are using baton charges, water cannon and tear gas in an atte

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

mpt, mostly unsuccessful, to keep the demonstrators under control.

The protesters are winning. They have managed to effectively block all road and rail access to the G8 summit. Impo

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

Examples of combination products may in

rtant participants are helicoptered to the venue while lesser important folk have to take police launches. One wonders whether German Chancellor Merkel had any idea when choosing the

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

venue, that the sea access could be such a saviour.

It seems strange that such a majority, which the police force has, is unable to control the demonstrators. It could boil down t

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

o the fact that the police have to abide by laws. They are dictated to by politically correct principles as set down by society watchdogs such as Amnesty International, the Red Cros

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

Combination pro

s or Geneva Conventions etc.

The demonstrators on the other hand feel that they are free to behave as they wish in order to make their point. They seem to be working along the lines

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

of, as long as they reach their goal, how they got there is irrelevant. The outcome they wish for, is to be seen and heard by the G8 leaders. They are frustrated that they have not

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

been able to get closer. It makes the demonstrators feel helpless and they, quite rightly, realise that nothing they say will make a difference.

This situation is played out on a m

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

uch larger scale in Iraq. The western forces are waging a war to try and control the Iraqi people and their various supporting interest groups. The Iraqi people, on the whole, do not

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

want to be controlled by the western world. They do not speak the same language, literally and figuratively. They do not have the same interests, except of course the oil resources

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

which the west wants to control.

What is happening in Iraq is exactly the same as is happening at the G8 conference. The Western forces are dictated to by the world's rules on how t

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

Following aspects would a

o wage wars. The Iraqi people have no such concerns. They want to be heard and listened to and preferably be left alone to determine their own fate. The average person doesn't natura

dd to the challenges in developing combination products:

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

lly take to arms or voice their opinions violently and in such a way as to risk their lives. This is always left to fringe elements or extreme political or religious groups.

Just as

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

the demonstrators have taken it upon themselves to represent the disenfranchised people of the world, realistically speaking without permission or a mandate from the world's citizen

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

s, in the same way Al-Qaeda for instance, represents the Muslim world against the West. Al-Qaeda and other terrorist groups do not have a direct mandate to perform their various nast

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

y deeds, and often have to intimidate to receive support or be condoned.

But to a certain degree they do represent the voice of the voiceless people which is why they are able to hi

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

Professional from academic institutions, pharmaceutical industries, health care indust

de away or launch successful attacks almost anywhere they wish. There is always some support on the ground available that provides shelter, access to sensitive areas, seemingly limit

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

less supply of explosives and weapons and the main ingredient - volunteers.

So what would stop the demonstrators at the G8 conference, and the violent resistance movement in Iraq? C

.

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

ould it be as easy as offering the demonstrators/resistance fighters a stage to speak on, which is actually heard, listened to, taken into consideration by the leaders and the leader

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

Companies that provide selfless information through particip

s make themselves accountable to them and deliver on promises? And offering a list of 'friends of the West' to vote for in Iraqi elections doesn't count.

Nah, couldn't be that easy.

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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