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Being one of the largest and most populated cities of Europe, London, the United Kingdom’s capital is a cosmopolitan area in which 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

highly diverse range of peoples, cultures and religions coexist today. According to a Guardian newspaper editorial, “London in 2005 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

n lay claim to being the most diverse city ever.” With more than 300 different languages spoken in London’s streets by its permanent

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

esidents, such a claim seems at least reasonable.

During my last London visit, I was astonished by the multicultural experience a to

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

rist like me could have, just by visiting different neighborhoods and talking to a variety of people. In fact, the city is considered

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

Combination pro

today to be an international transport hub and an extremely popular tourist destination, making London one of the most visited world’

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

capitals; a fact that tremendously promotes its multicultural character.

London’s metropolitan are has considerably grown over the

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

enturies, especially during the 19th and early 20th centuries increasing industrialization that led to rapid population growth. Engla

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

d’s capital was the most populated city of the world until 1925, when New York overtook its immense number of citizens. London contin

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

ed to grow until World War II and the Green Belt legislation which led to its population largely remain static. But although urban bu

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

lding constructions were not allowed to take place at the same speed as before, the city’s habitats’ number continued to increase. To

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

Following aspects would a

day, London’s wider metropolitan area has a population between 12 and 14 million depending on the definition of that area. According

dd to the challenges in developing combination products:

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

o the 2001 census, 27 percent of London’s population was born outside the UK and about 29 percent were classified as non-white –non-c

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

unting the unknown tens of thousands who did not complete a census form. But even this total does not include the second the third ge

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

eration immigrants, who have inherited the traditions of their parents and grandparents.

Ethnically diverse and historically rich, L

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

ndon continues to attract people from around the globe who find in its neighborhoods their new home. London in 2006 is uncharted terr

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

Professional from academic institutions, pharmaceutical industries, health care indust

tory. According to sociologists and historians, never have so many different kinds of people tried living together in the same place

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

efore. Virtually every race, nation, culture and religion in the world can claim at least a dozen of Londoners. But, what some people

.

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

see as the greatest experiment of multiculturalism of the last centuries is already challenged by the global political and social dev

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

Companies that provide selfless information through particip

lopments which have recently begun to point out that harmony and peace are more than ever subject to the powers of race and ethnicity

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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