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Disasters, Floods, Landslides, Hurricanes, Earthquakes
The Country of Honduras often gets huge storms during the Atlantic Tropical Hurricane Season as this extreme weather that

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

develop in the Caribbean comes ashore and the energy is trapped by the mountainous terrain causing torrential downpours. In last week of October in 1998 Hurricane Mitch devastated

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

Examples of combination products may in

onduras and killed more than 5,657 people (some estimates were 7,000) and created 2 million homeless (nearly 12,000 missing); most were children. The Banana Crop was destroyed too

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

nd the economic loss was huge for the Nations.

It was the worst recorded Hurricane in over 200 years and each year folks worry that another catastrophic storm could hit. The 2005 H

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

rricane season also had major storms that affected the Banana crop and flooded out many as well as resulting in massive deaths. Honduras is known for Hurricane weather especially al

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

Combination pro

ng the Caribbean coastline and the flood damage is all too common. Inland landslides in the mountains also result from Hurricane storm remnants. More people are killed by the landsl

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

ides and severe flooding or storm surges than the actual winds. Landslides and flash flooding have been known to bury entire villages within minutes in the mountainous regions of Ce

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

tral America.

Honduras is also very prone to Earthquakes, which makes sense if you look at its tall mountains, which did not get there by accident. Honduras has many Earthquakes ev

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

ry year, only a few are really serious. Occasionally a biggie comes along and wrecks havoc on the people there. There have been notable Earthquakes of six or greater magnitudes and

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

wo 7 magnitudes since the new millennium. Some of the Earthquakes come from off-shore in the Pacific Ocean while some epicenters occur on land.

Honduras also has Volcanoes and alth

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

ugh they are not a huge issue, they are common in that region of Central America. Of course this also provides opportunity for Geo-Thermal Energy, which is a big plus for the Nation

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

Following aspects would a

, as it grows in economic status and population. Honduras will need more energy in the future as the population grows about 2.4% per year.

Disease and HIV Crisis
HIV is causin

dd to the challenges in developing combination products:

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

severe concern in the country and many are now calling it an epidemic, as about 1.5% of the population of Honduras has HIV and are living with the virus. That number is growing at

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

n alarming rate according to the World Health Organization and United Nations. This is the highest percentage in Central America. Although Honduras is roughly only 18% of the total

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

opulation in Central America, it has nearly 60% of the known HIV/AIDS cases. Out of this huge HIV/AIDS virus infected folks only about 5,000 are receiving any treatment presently.

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

ccording to Walking With Children, a non-profit group in Wisconsin, USA they estimate almost 4,000 children are living with HIV now. Their group has set up a legal entity (Foundatio

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

Professional from academic institutions, pharmaceutical industries, health care indust

n) to build a center in hopes of that model being used throughout the nation to combat the AIDS crisis. They will assist with "the best quality care and education to persons infecte

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

with and affected by HIV/AIDS." Currently they are also working to foster psychological programs in Spanish for children and adolescents. They are indeed doing incredible work ther

.

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

along with other fine organizations. [www.walkingwithchildren.org].

Still 1.5% seems low since there are now places in the Congo in Africa where the HIV/AIDS rate is over 50%. Eve

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

Companies that provide selfless information through particip

still HIV/AIDS is something you must keep track of and work on because if it gets out of control over 6.5 million Hondurans will be at risk, according the World Health Organization

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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