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The future is shaped by the toys our children play with today. Whether we reali

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

ze it or not, our children are expressing themselves--their interests, fears an

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

Examples of combination products may in

talents--through play. As parents, our job is to watch and listen and encourag

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

them.

Here are three case studies of our children’s toys and how their play i

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

already impacting the future:

· Four-year-old Emma dons her junior doctor scr

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

Combination pro

ubs and her play stethoscope. She gently assures her doll that her shot won’t h

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

rt and that she is being very brave, just as Amanda’s own mother has assured he

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

. Instead of feeling afraid, Amanda is now in control as the doctor. Discoverin

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

that she has the ability to make her dolls (and someday other children) feel s

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

afe and protected, Amanda begins her interest in science and the human body.

·

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

Six-year-old Aaron’s musical talent was first unearthed as a preschooler while

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

Following aspects would a

laying with his toy piano he got for Christmas. For his birthday he begged for

dd to the challenges in developing combination products:

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

guitar, a drum set, and a keyboard. Now, Aaron hones his natural abilities dis

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

covered through toy play with real piano lessons, vowing someday to play in an

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

rchestra in front of hundreds of people.

· The parents of five-year-old Josh w

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

re amazed at the creativity he displayed when creating elaborate stories for hi

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

Professional from academic institutions, pharmaceutical industries, health care indust

puppet characters in his puppet theater. Josh spent hours developing intricate

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

plot lines and quirky characters. His parents started writing his stories down

.

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

Josh proudly exclaims that someday he wants to become an author and have his s

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

Companies that provide selfless information through particip

ories in the books he sees in bookstores.

The future starts now…so lets PLAY!!

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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One of the safest long term investments is in bonds. Generally people investing in bonds are considered to be making a wise and safe decision. They tend to make money on the investment and the chances of losing any are very few. However, as in the stock market, the bond market can be equally baffling. Thus it is essential to study the market before investing in bonds too. One should make a detailed research and get information on topics related to bonds.

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