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References - Outside Casa de Sion Orphanage, Guatemala
Guatemala City is typical of this beautiful land with so many contrasts. It's a sprawling city of over two milli
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
on people. You'll find The Marriott, your friendly McDonald's, Pizza Hut, numerous familiar car dealerships and
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ll the other accoutrements you'd expect in an average American city. There are wide tree-lined boulevards, tall
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
uildings, crowded crosswalks and smog. There are vendors at every stoplight selling beautiful flowers, home-grow
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
n fruits and vegetables plus everything you'd expect to see at your local flea market: hardware, cell phone jack
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
, tee-shirts, etc.
As you move away from the center of the city you see the patches of the utter poverty that p
As you move away from the center of the city you see the patches of the utter poverty that p
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
ague the country. The prolonged civil war forced many to relocate from the country to the city. Slums consist of
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
bamboo and cardboard shacks with corrugated tin roofs. There is little running water and even less sanitation.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
n average good salary is $10-12 / day. Subsistence is a way of life whether it's farming or manual labor. Owning
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
a vehicle--no matter what it looks like--is a sign of status. Corruption is a part of everyday life. All banks a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
d any business with an inventory have an armed guard.
The society consists of haves and have nots. There is no
The society consists of haves and have nots. There is no
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
social safety net. No welfare program of any sort. Although there are "free" public schools, books and uniforms
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ost a month's salary and many children on the streets are illiterate.
The children that come into the orphanage
The children that come into the orphanage
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
are ordered from the court system. They are the refuse of society. With no financial help from the government,
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
charitable organizations operate rescue centers. They offer hope where there was none, three meals a day, school
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
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
ng, religious training and a chance at life.
The countryside can be even worse. Many areas have an even lower d
The countryside can be even worse. Many areas have an even lower d
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ily income. The children are recruited by their parents to sell craft and clothing items the parents make. Somet
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
imes in both the country and the city they are recruited to beg, or worse. We have seen 10 year olds hauling aro
.
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
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
nd their younger siblings and begging off the tourists. The courts are overwhelmed with a need for suitable shel
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ers for children, as they have no where to send street children or abused children who need a safe place to stay
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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