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I remember just a handful of the Christmas presents I received as a child: My first Barbie doll with her skinny black sequined gown. My soft, p

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

ink Pat-a-Burp doll. The microscope I got in second grade.

But I have many, many memories of our holiday traditions. The lovely aromas of holi

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

Examples of combination products may in

day ethnic food. Riding the South Shore train into Chicago to visit the "real" Santa. Using a paintbrush to decorate sugar cookies with colored

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

frosting. Setting up our manger scene.

Traditions add so much joy to the holidays. Traditions give a child a sense of belonging and identity.

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

They strengthen bonds across generations and live long in memory.

A family rich in traditions has a powerful antidote to commercialism. The m

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

Combination pro

ore focused you are on pleasures that cost little or nothing, the more all the gifts tend to stay in their appropriate place.

Best of all, man

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

y traditions are perfectly suited to today's busy families. Here are a few favorites:

SIMPLE PLEASURES

Light candles at dinnertime. If Decemb

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

r mornings are dark where you live, light candles at breakfast, too.

Take an evening stroll or car ride to look at Christmas lights.

Serve wa

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

rm chocolate with candy canes for stirring.

THE JOY OF GIVING

Let your kids in on the excitement of finding and wrapping gifts for those they

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

love. Compliment them for being big enough to keep the surprise a secret.

As a family, decide on a charity and make a donation. Our favorite

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

is Heifer International (www.heifer.org).

Take a plate of cookies or other holiday treats to a homeless shelter or to a police or fire station

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

Following aspects would a

.

GRATITUDE

Give family members strips of paper in holiday colors. Let everyone write or draw something they're thankful for on each strip. L

dd to the challenges in developing combination products:

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

ink the strips into a chain and hang as a decoration.

Write thank-you cards to each other. Decide together when to open them.

CONNECTING GENE

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

RATIONS

Interview grandparents, aunts, and uncles about holiday traditions they remember from their childhood. Adopt any traditions that fit y

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

ur family.

Ask relatives for holiday recipes that have been handed down in your family. Or, search the Internet for holiday recipes related to

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

your ethnic origins.

NEW YEAR'S EVE

If your kids are little, it works fine to celebrate the new year at 9 PM instead of midnight!

Pull out

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

Professional from academic institutions, pharmaceutical industries, health care indust

photos and videos from the past year and share your memories.

Keep a box of inexpensive noisemakers and party hats that you can re-use each ye

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

ar. The kids will enjoy pulling out their old favorites.

NEW YEAR'S DAY

Decorate a box in which you'll put photos, ticket stubs and other sou

.

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

veniers of the coming year. Talk about your hopes and wishes.

Let each family member put New Year's resolutions into their own envelope. Autho

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

Companies that provide selfless information through particip

r Mimi Doe ("Busy But Balanced") has a tradition of sealing the envelopes with wax -- a nice, magical touch.

(c) 2004 Norma Schmidt, Coach, LL

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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