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Our school systems cannot fund one-on-one assistance to our children as we

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

pack 20-30 into a classroom. Our teach attrition rates are 50% in the first

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

Examples of combination products may in

five years alone in the public school system. Each year more autistic chil

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

ren are born and they need 1:1 special therapy, but with funding the way it

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

is today in our schools that is highly unlikely in happening anytime soon.

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

Combination pro

One parent writes in an email;

“As you can imagine, school districts, su

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

h as mine, do not want to pay for any 1:1 intervention, claiming that their

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

programs are more than satisfactory. And if they do employ some 1:1 time,

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

it is usually with an aide who often lacks the experience and capability t

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

facilitate lessons. In New Jersey, districts only have to provide an "appr

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

opriate program" -- a very subjective term. The proposed school program is

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

Following aspects would a

indeed appropriate if the goal is to have my son in a group home upon my d

dd to the challenges in developing combination products:

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

ath.”

You can certainly see the issues involved in supporting our autistic

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

children and the need to better educate now to save money later. This same

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

argument could be applied to mentoring of kids at risk, to prevent them fr

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

m getting into gangs, drugs, crime and costing society a lot more in the fu

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

Professional from academic institutions, pharmaceutical industries, health care indust

ture. Most people can see this dilemma and the funding issues in our school

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

s and the training required to properly help our autistic children along, a

.

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

they are a huge asset to our civilization and scientists are just starting

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

Companies that provide selfless information through particip

to learn that as well. Consider all these points and think on this in 2006

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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In the recent International Wine and Spirit Competition (IWSC) the first prize for the Top Pinotage was awarded to Stormhoek, a small independent winery in South Africa. Two years ago they were virtually unheard of in their own country - let alone the rest of the world. So how did they manage to gain so much growth in so little time?

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