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In twentieth century America while young boys learned construction with Lincoln Logs, little girls instinctively cuddled a Raggedy Ann. Even today Raggedy Ann’s red yarn hair, patched pinafore and bu

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

tton eyes offer images of another era as she celebrates her 90th birthday in museums and private collections.

But in 1958 Barbie was born. All grown up and designed with fantasy. This was no rag do

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

Examples of combination products may in

ll. Barbie’s hair was real and brush-able; her wardrobe generous and trendy. The ‘Barbie’ figure was to become the ultimate achievement of the perfect body. Playing with Barbie during formative ye

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

ars, young girls have acted out all of their dreams.

The new millennium brought new images for females. Lifestyle issues changed the way the media influenced the female psyche and redefined some old

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

messages about life, love and growing pains. “Stay sweet” changed to “Be strong”. “Find the right man” changed to “Get your degree”. Careers in nursing were discouraged as parents pushed for Compu

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

Combination pro

ter Science.

While professional women are up from 48% in 1993 to 50% today, they still hit a glass ceiling when it comes to the corporate pay scale. Some would blame it on the more aggressive male w

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

ho thinks nothing of asking for his pay raises. There is truth in that observation; women tend to let the high quality of their work speak for itself.

Can white-collar females have successful relati

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

onships with blue-collar males? Good question. Confucius once said, “Ignorance is a woman’s virtue”, but you won’t sell that idea in the twenty-first century. Ironically, intelligence and high prof

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

essional positions can be obstacles unless one prefers being single. Oprah Winfrey is a good example of a marathon courtship by choice.

A single woman’s living quarters is a key indicator of her eco

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

nomic status. Virginia Woolf said that a room and sufficient money were enough for a woman who wants to write. But today, single females want more. A home provides personal space and a sense of sec

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

urity to say nothing of a good investment.

In a corporate setting the female personality better be competitive. If you are aggressive in your climb to the top, if you have something to offer that yo

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

Following aspects would a

ur male counterpart cannot, you may do very well. But the average starting salary is about $40,000 annually and may, after five years increase to $80,000. Perks will be offset by wardrobe and travel

dd to the challenges in developing combination products:

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

expenses. Is this enough?

Women have unique skills with gender-related characteristics. They are excellent listeners and communicators, often better able to build trust among both sexes. They are

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

known to be more effective team builders than men. Perhaps unconsciously, when groups of newly introduced men engage in conversation they establish a pecking order. Women converse to cultivate a gr

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

oup bond.

When women are forced to balance career and family, something suffers. A marriage can end up in divorce. Children grow up with too much freedom. The promotion you waited for goes to your

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

trainee. Cutbacks eliminate your job. While this is not always the case, it happens often enough when considering life in the fast lane.

There is another way. Certainly not as glamorous but pulls

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

Professional from academic institutions, pharmaceutical industries, health care indust

in a six figure income without a resume or a business degree of any kind. This is the best time to begin an online business.

Launch one today -- you don't have to make it all up from scratch. There

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

are first-class recipes out there! Do it because it's still the likeliest, fastest, and best way to get rich. Do it because of how universally accepted being an entrepreneur has become. Do it beca

.

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

use it is a way out and a way through; think of the wake you’ll create!

Do it because we’re not rookies anymore, because the risk-reward equation has flipped. Do it because there is something within

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

Companies that provide selfless information through particip

you that is uniquely yours; you own it yet rarely acknowledge that it’s there. The offer’s on the table! It’s time now to bring it out, give it a title and share it with others.

© 2005 Esther Smith

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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