Actual - Insurance

With the difficult terrain it is not easy to bring aid into the small villages in rural Honduras. Most supplies must be brought in by four-wheel drive truck over sometimes ver

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

y treacherous dirt roads. Buses traveling between the large cities often get stuck, relying or hoping for locals with

large draft animals to pull them out. Nearly every four-

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

Examples of combination products may in

wheel drive vehicle that makes the journey has shovels in the back or behind the seat. When non-profit groups need to bring in machines or building supplies it is often nearly

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

impossible to get them into the villages and this makes building a slow process.

Often volunteers ride in the back holding down the equipment and or building materials, keep

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

ing their arms inside the truck or they get mudded. Still other times they must get out to prevent the vehicle from bogging down in the mud when it gets stuck. "It is a bumpy

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

Combination pro

ride to say the least" stated one recent volunteer.

The bumpy ride can damage materials or machines and tools being brought in and it is a long way back to civilization to ge

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

t replacement parts. Thus a simple job can takes weeks and depending on the season, perhaps months to get thru a mountain pass road which is closed due to a landslide. The mor

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

e remote the village the tougher it becomes. A simple construction project such as building a school, church or miniature sewer treatment plant could take months or sometimes

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

have to wait to be finished season or even next year.

Assistance from North America

Much of the AID that comes into Honduras comes from other countries, although there are m

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

any religious groups there that really work hard to help the locals help themselves. As the country's network of churches and organizations grows stronger we see that all the

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

hard work from the volunteers who come from North America is paying off.

Doctors and Medical Missions

Often Hospitals, University Medical Students and practicing doctors wil

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

Following aspects would a

l organize groups and come to the rural areas of Honduras to assist people. Many Church groups will also recruit doctors, nurses and medical professionals to come along or hav

dd to the challenges in developing combination products:

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

e such members already in their groups who will volunteer. The combination of all these medical missions is awesome.

The UB Church is one group that travels to Southern Hondu

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

ras to the many Mountain Villages, which have little if any medical care. They take with them doctors, medical assistants, physical therapy people, nurses, dentists and EMTs.

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

Like most groups they land at the Capital City of Tegucigalpa and then take buses and sometimes pick-ups into the villages. Volunteers often pay their own way; others are spon

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

sored at $1200 each. They figure that;

"If at least one physician accompanies the team, we can purchase enough medication to assist with 1000 patients for a very small cost."

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

Professional from academic institutions, pharmaceutical industries, health care indust

Their strategy seems to be paying off as during each medical mission they are assisting more and more people who are in desperate need of medical attention.

Another medical

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

group from Austin Texas from "The St. Williams Medical Missionary Team" which is a private group relying solely on personal donations. They told of some pretty bad cases of i

.

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

nfections and about the long lines of those in need of medical help. Due to the high volumes of people needing help things must be set up very quickly turning the building int

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

Companies that provide selfless information through particip

o a drop-in health clinic with lines as far as you can see.

"When we set-up our clinics, we often have very sick and dirty dogs running around “from one office to the other”.

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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