References - Travel and Leisure

The German tsunami relief convoy reached the Paranthan junction, which is the last nor

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

thern point in the mainland of Indian Ocean's war-torn island, where people lived in t

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

Examples of combination products may in

e midst of the civil war in 1996.

I had been there for a brief period of time when I

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

as working with CARE International. The Elephant Pass strategic military camp of Sri L

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

nka Army was stationed there. The camp was a major coveted target for LTTE since their

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

Combination pro

failed attempt in 1991 along with heavy losses of cadres.

When I was staying in that

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

icinity in 1995, the vulnerability of that area was an every day presence. The artille

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

y shells were pouring at times like thunderstorm. Some of the shells had fallen near m

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

house and in one incident I narrowly escaped. But a known girl nearby died, of shock

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

aused by the heavy explosion of an artillery shell. I was able to recall how her two s

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

sters were crying when her body was being taken for cremation along the same high way

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

Following aspects would a

n which I was traveling with the German Praktikum (Internship) students in the relief

dd to the challenges in developing combination products:

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

ission.

After that incident and continuous artillery shelling, the Area Director of C

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

RE International in Kilinochchi asked me to get away from that area a number of times.

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

But I was reluctant to leave as I was used to the artillery shelling and aerial bombin

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

s since my childhood in the war-torn northern Jaffna Peninsula. But for the Area Direc

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

Professional from academic institutions, pharmaceutical industries, health care indust

or, her upbringing in the New York City in a calm and quiet atmosphere made it hard fo

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

her to accept my explanation.

Finally I left that area for a while. But memories sti

.

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

l came alive when I was looking at the demolished buildings and the surroundings on th

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

Companies that provide selfless information through particip

way. Our five-vehicle convoy was now speedily hurrying through a one-time No-Man Zone

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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I'm always amazed at the fun things George has up his sleeve after all these years. I mean, we're in our late 60's and people often mistake us for newlyweds! Can you imagine? George always gives me little hints about our trips and all he would say is that we were going to a Florida attraction I'd never guess. He sure was right! George surprised me just last week on our 45th wedding anniversary with a brochure on Cypress Airboats.

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References - German Memory in Asia: The War-Torn Memories in Asia

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