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When Barbie strolled onto the world of dolls in 1959, everybody knew it will change the doll scene forever. Since Mattel in

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

troduced her, more and more girls all over the world fell in love with the most popular and lovable creation. Aside from th

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

Examples of combination products may in

e dolls itself, Barbie and everything about her became quite a hit to so many endeared markets—especially her long-standing

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

relationship with Ken Carson.

UNFOLDING BARBIE AND KEN'S JOURNEY

After the introduction of Barbie in 1959, the creators o

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

f the world's most-loved doll decided to give her a companion in the form of Ken in 1961. Barbie and Ken, who was created b

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

Combination pro

Ruth Handler, co-founder of Mattel, Inc. were named after the creator's daughter and son. Since their introduction as a co

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

uple, Barbie and Ken have been known to have on-and-off relationship.

The loves story of the two plastic dolls started whe

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

n Barbie met Ken on the set of a TV commercial in 1961. since their first meeting, the couple has and been inseparable ever

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

since. Through the years, the couple's fans around the world followed their "perfect" love story. Everybody hoped that the

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

two would end up together but the possibility was thrown into flames when the two decided to part ways in 2004.

After 43 y

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

ars of being together, the world's most famous couple in the doll scene has decided to end up their affair but claims it's

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

Following aspects would a

only temporary. Like the break ups of famous couples in Hollywood, the break up of Barbie and Ken was big news.

According

dd to the challenges in developing combination products:

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

to Mattel vice president of Marketing Russell Arons, the plastic couple's "business manager," the break up stemmed from the

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

fact that the couple wanted to spend quality time apart. And though their romance came to an end, the pretty ex-couple cont

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

inued to friends. According to the news, the relationship ended because of the overwhelming pressure of always being scruti

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

ized by public eye.

Others say that Ken's vague sexuality and Barbie's disproportionate figure may have finally taken thei

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

Professional from academic institutions, pharmaceutical industries, health care indust

r toll between the two. While other suspect that Barbie's career and popularity over Ken's must have been the real issue be

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

tween their differences. But, Barbie fans insist that Ken's refusal of tying the knot with the world's most popular fashion

.

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

doll might have pulled the trigger and ended up the couple's romance.

Despite the rumors spreading about the couple's brea

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

Companies that provide selfless information through particip

k up, Mattel assures that the status of the dolls' relationship is temporary, thus, their relationship can be revived again

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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