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Iceland is an not a very interesting place to study tectonic a

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

s no Earthquake fault lines are known to exist there yet latel

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

Examples of combination products may in

y they have been having some seismic activity there. Now that

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

you are thinking how can that be you are inline with the discu

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

sion recently at an online think tank when one member, Swift f

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

Combination pro

rom Las Vegas, brought the subject up and stated;

“Iceland ha

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

s appeared to have quite a bit of activity in the past couple

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

f years seismically. They are looking at the ice masses slippi

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

ng, as the magnitudes of the quakes aren't associated with kno

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

wn faults and are between 4.6 and 5.1. There have been 136 of

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

hem between 1993 and late 2005 along the SE and SW coasts all

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

Following aspects would a

originating beneath glaciers which flow of at least 2 KM a yea

dd to the challenges in developing combination products:

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

r. 3/4 of them occur beneath the island's largest glaciers, Ka

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

ngerdlugssuac, Jakoshavn Isbrae, and Helhem.”

This is very in

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

eresting and one could say that climate change then in fact ca

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

n cause Earthquakes. Yet we also know that large movements can

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

Professional from academic institutions, pharmaceutical industries, health care indust

trigger Earthquake faults also. Does this mean that climate c

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

ange or Global Warming if you wish to stick with that theory w

.

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

ill cause Earthquakes? Is mankind in for a rocky road in the n

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

Companies that provide selfless information through particip

ext decade or two? Well perhaps you will consider this in 2006

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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