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There is a chore in my home that brings out the procrastinator in me. This particular chore is so big and so difficult,

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

that I create new tasks just to avoid starting the dreaded job. What could be so bad: My toddler’s bedroom – a.k.a. fi

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

Examples of combination products may in

hting the battle of ‘too many toys!’

The problem doesn’t arrive from a lack of organization or space to put things, bu

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

t from just too many toys in the first place. His room, when tidy, looks like a little toy store gone mad. My husband b

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

ilt custom shelving just for the toys and books, with varying shelf sizes to accommodate different types of toys and si

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

Combination pro

zes of books. However, when I take a close look at the contents, it’s obvious that there’s lots of ‘stuff’, but little

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

hought went into most of it.

How should you select and organize your child’s toys? Choosing quality kids’ toys, select

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

ed by their developmental stage and abilities, is the first step. Most toys have a recommended age on the package to le

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

you know the appropriate age group. Take cues from you own child to guide you in whether he is ready for a certain toy

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

.

Make sure that the toys you’re buying actually "do" what they are supposed to. If puzzle pieces aren’t cut correctly

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

your child will get angry and frustrated when they play with it. I’ve recently made the mistake of buying a puzzle tha

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

Following aspects would a

was supposed to be appropriate for ages 18 months to 3 years, only to find that the pieces were very difficult to plac

dd to the challenges in developing combination products:

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

e, and my son became upset every time he played with the puzzle.

Some suggestions for Toddler and Preschool Toys

• Pu

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

pets

• Activity tables/centers

• Sorting boxes

• Snap together Blocks – Leggos

• Puzzles – up to 5 wooden pieces

•

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

Figures for dollhouse, farm, etc.

• Dress up clothes

• Trucks and wagons to haul things

• Housekeeping and shopping

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

toys

• Sewing cards

• Buttoning, zipping, snapping dolls or boards

• Preschool age games like Memory and Candy land

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

Professional from academic institutions, pharmaceutical industries, health care indust

etc.

Most importantly, choose toys that stimulate your child’s mind and that create learning experiences. Provide an a

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

equate amount of toys for your child. Don’t do as I have and overwhelm your child with too much ‘stuff’ causing both of

.

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

you to become frustrated. As we all know, most little kids have a more fun playing with the box the toy came in while

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

Companies that provide selfless information through particip

he new toy sits idly on the floor. Now it’s time for me to stop procrastinating and fight the battle of ‘too many toys.

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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