References - Travel and Leisure

O’ Connell Bridge spans the River Liffey and joins the North Side and South Side of

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

Dublin. O’Connell Bridge is unique in Europe as it is the only bridge that is wide

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

Examples of combination products may in

than it is long. Today the bridge marks the very centre of Dublin as it joins O’Co

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

nell Street to D’Olier Street.

Originally the bridge was named the Carlisle Bridge

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

after the Lord Lieutenant of Ireland at the time, Frederick Howard, 5th Earl of Car

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

Combination pro

isle. The bridge was designed by James Gandon, a famous Irish architect whose name

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 associated with many of the great Georgian buildings in Dublin. The construction

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 the bridge took three years and was completed in 1794.

It wasn’t until 1879 that

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

more work took place on the bridge when it was decided that the bridge should be wi

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

ened to allow greater traffic flow. The bridge was widened to the same width of Sac

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

ville Street, now O’Connell Street. The bridge was reopened in 1882 it was renamed

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

Following aspects would a

n honour of Daniel O’Connell and a statue in his honour was erected.

O’Connell had

dd to the challenges in developing combination products:

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

been a famous lawyer who campaigned for the repeal of the Union between Ireland and

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

the UK. He only used non-violent means and for this he has been remembered as a her

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

. He stands in stark contrast against the IRA and the UDF who used bloodshed to ach

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

eve nothing other than to tear apart a province with violence.

O’Connell Bridge is

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

Professional from academic institutions, pharmaceutical industries, health care indust

’t the only bridge so named, the second being the bridge that spans the pond in St

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

tephens Green. In 2004 a number of pranksters installed a plaque on O’Connell Bridg

.

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

dedicated to Farther Pat Noise, a fictitious priest. The plaque remains on O’Conne

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

Companies that provide selfless information through particip

l Bridge to this day and wasn’t noticed by the Dublin County Council until May 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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References - O'Connell Bridge, Dublin

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