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What parent has had that moment of fright when the child who was just at your side is gone? Usually the child has seen something of interest and just gone to investigate, or ha

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

s gotten separated in a crowd, such as being at a carnival, and although it may only two seconds to locate your child, it feels like two years and when you do find them your hea

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

Examples of combination products may in

t is racing, your hands are shaking and you don’t know whether to hug them or scold them.

The possibility of someone taking our child is a real fear every parent carries with t

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

em. Just pick up a newspaper or watch the evening news and reports of children being kidnapped or abducted are constant and the heartbreak of the parents is just so overwhelmin

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

. Now what if there was a technology that could find that child instantly?

GPS technology is now being used to help keep track of children and allow parents to know where the

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

Combination pro

r child is at all times. These devices are usually small enough to fit anywhere-backpack, pants or coat pocket, etc. and lightweight enough not to be burdensome. Some of these

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

have pre-programmable buttons so the child can keep in touch with their parents or call for help if necessary.

These devices range from tracking devices that will beep until t

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 child is found, to cell phones with GPS technology installed, to watches that if forcibly removed will automatically activate. There are even backpacks available with GPS tec

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

nology installed. Some of these will activate if the child is too far away from the parent. And there is even one that is implanted in a shoe.

Of course the main problems wit

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

these are the child is going to lose them, or if the child is abducted they can easily be disposed of. I can envision the day when it will be possible to have a GPS transmitte

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

implanted in a child via an injection or some other simple manner.

There are other concerns also. Are only children with parents who can afford this technology are going to b

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

Following aspects would a

enefit. Is this going to increase the number of lower class children, whose parents can’t afford this new technology, being abducted? Will someone, such as a child molester or

dd to the challenges in developing combination products:

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

kidnapper, find a way to use a child’s transmitter signal to locate the child? Also how are our children to adjust to the fact that th

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

y are constantly being monitored?

How secure are our children going to feel knowing that the world is so dangerous that their parents need to know where they are at all times?

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

Are we stripping a part of their childhood away from them? Who doesn’t remember, as a kid, going somewhere you knew your parents didn’t want you to go, but as children we are a

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

venturers, and if we got into trouble or got ‘caught’ being where we shouldn’t be, we more than likely not only got punished but also learned a lesson. We grow and mature by ma

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

Professional from academic institutions, pharmaceutical industries, health care indust

king mistakes and learning from them, are we going to take part of this education away from our children? At what age do we stop? Do we continue to monitor them through their

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

een-age years? A time that can be the hardest time of any child’s or parents life, it’s a time where a teenager needs to mature and a parent needs to learn to ‘let go’ and all

.

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

w the child to learn on their own-mistakes and all.

Although this technology has some very great qualities in the protection of our children, the possibility of abusing this te

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

Companies that provide selfless information through particip

hnology must also be addressed. We all want our children to be safe, yet at the same time they must be allowed to grow to become functional adults.

Copyright 2006 Angela Carte

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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