Advice Pool - Insurance

There are so many emotional stories about children and their families and the medical assistance that is so desperately needed. Let us share just a few more with you, this one from a medical mission in 2005;

"I have see

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

n so many cases of cerebral palsies, I found it incredible. People take these misfortunes with resignation and carry their crosses. Often, the women do not have pre-natal care, suffer from severe anemia and malnutrition

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

Examples of combination products may in

and give birth alone at home. When the birth is complicated and takes long, the baby is often born stillborn and they burry it in their backyard."

The women of rural Honduras are unbelievable and will do whatever it tak

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

s for their children, often sacrificing them selves and struggling just to give their children a better life. It is amazing to see that level of commitment and strength of character. Each one deserves a medal of honor fo

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

r their daily endeavors. You cannot help but feel the raw emotions as you watch them. Nathalie told us these emotional stories after her medical mission journey;

"I saw a woman who was carrying her 8-years old (almost 1

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

Combination pro

00 pounds) vegetative gorgeous looking girl for hours to come and see us. We got to talk and I explained to her there was not much I could do for her daughter. I shower her exercises to prevent stiffness and told her wha

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

to feed her. The little girl will eventually die soon. The mother told me she had another birth the year before but the baby was stillborn. Her husband who was often absent and could not deal with his wife’s pain, was o

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 no support. The woman then told me:” If my little girl dies, I will kill myself!” We hugged and cried together…"

"There was a little girl who had severe burns on all her back and was in bad pain. Jeff [another medica

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

l doctor on the team] changed her bandages and gave her a Penicillin shot. The medications we use are the ones we brought and we rapidly run low on the essentials. The people working at pharmacy are awesome and get to be

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

very “creative” in helping as many people as we can. It happened some days that we had to “cut the line” as it was impossible to see everyone. Most people are very understanding and ask us where we will be the next day a

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

nd start walking towards that direction hoping to be the first ones in line the next day. "

"I saw another old lady who was about 70 years old. She was a widower and complained of back and neck pain. She was accompanied

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

Following aspects would a

by 3 children. I asked here where their parents were and she answered me “le matar". I asked her to repeat as I was not sure she really meant someone had killed her daughter. She told me that she had three more children

dd to the challenges in developing combination products:

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

at home. She was sleeping on the dirt floor and at night and had only three tortillas to spread between the children and herself. That got me tears into my eyes. I slipped her some money and told her not to tell anyone a

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

s I did not want to start a riot. She hugged me and thanked me deeply. I often think of her and wonder how she is doing."

All volunteers are needed and all types of professional medical people are needed regardless of t

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

heir specialty. There are so many people that need assistance and the lines of those in need of medical attention are so long that every single person is a valuable member of the medical team and you will be surprised ho

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

well you will do and all the good you can bring. Dr. Nathalie Fiset drives the point home in her original reservations;

"To be honest I was a little concerned about doing the missions at first since I only do obstetric

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

Professional from academic institutions, pharmaceutical industries, health care indust

s in my medical practice. The cases were so obvious though that I got comfortable the very first day especially when someone comes with diabetes and their sugar levels are at pre-coma levels often, same thing for high bl

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

ood pressure: the numbers are mind blowing. When the other doctors treat people with diabetes or high blood pressure, they can only provide a couple of day’s supplies of medications. We are aware that this will only help

.

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

to control the disease for a short period of time…until another medical brigade comes along."

There are many ways a person can help people from Honduras. Any help is well appreciated and makes a difference. People somet

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

Companies that provide selfless information through particip

imes hide behind the excuses that they are not doctors or nurses to avoid helping. There is so much to be done. For example, Lance Winslow, a writer, donated his time to create a complete e-book on the needs in Honduras

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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Advanced process control has come to be a term synonymous with computer based technologies. Many companies use this process to help them with increasing their...

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