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The Baby Boomers generation defined a sociological group of individuals who protested, pronounced and declared their independence as a socially conscious, trend setting generation. The Baby Boo

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

mers have shared consciousness unlike any other generations. These individuals grew up watching “”The Mickey Mouse Club on TV. They also experienced the horror of the assassination of a Preside

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

Examples of combination products may in

nt.

The Baby Boomer generation is defined as those individuals who were born between the years of 1946 through 1964. The Baby Boomers got their name because of the huge population explosion th

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

at was created at the end of World War II when the troops returned home to their wives and girlfriends.

The population boom and the Baby Boomer era officially ended in 1960 when the first birth

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

control pill officially came on the market. The full impact of the birth control pill reached its zenith in 1964 when the population boom was official declared over.

The Baby Boomer generatio

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

Combination pro

n lived through and contributed to some of the most decisive moments in the history of a nation. These same protestors have become a part of American History. Our two most recent presidents, G

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

eorge W. Bush and Bill Clinton were born in this era.

The Baby Boomers were the protesters of the Vietnam War. These were the men and women who fought in the war. Also, they were the conscient

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

ious objectors who refused to fight in what they considered an unjust war. These were the hippies who spearheaded the “sit-ins”, the shutouts "smokeins" and walkouts of the 1960’s era.

The B

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

aby Boomers defined the rebellious spirit of the 60’s. Some social scientist consider the "60"’s as the decade that changed world. These boomers were the motivators of this social consciousnes

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

s. One sociologist declared “ There will never be a decade or group of individuals that have had such an enormous social impact on the world.

The Baby Boomers fought for freedom and equality.

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

They fought for civil rights and women’s rights. They took up the cause for the gay rights movements as well as abortion rights. They smoked pot and hung out in Volkswagen buses. Now these sa

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

Following aspects would a

me Baby Boomers face the biggest fight of their lives - Alzheimer’s disease.

A generation of movers and shakers is now headed toward the most ominous challenge of their lives. This challenge l

dd to the challenges in developing combination products:

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

ooms over them not because of lifestyle, race, creed or color but age. Age seems to be the one common factor among people who are most likely to be victims of Alzheimer’s disease.

Alzheimer's

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

disease is an ongoing threat for anyone over the age of 60 years of age. The last of the Baby Boomers will reach their 41st birthday this year. Alzheimer’s disease affects approximately 4.5 mi

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

llion people in the U.S.

Over time, Alzheimer's disease will gradually these eager retiring Baby Boomers into a vegetable who has no memory or ability to learn. These individuals who succumb t

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

o Alzheimer’s will not be able to talk, eat or even go to the bathroom without assistance.

For a generation of vibrant socially responsible individuals, Alzheimer’s disease represents the great

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

Professional from academic institutions, pharmaceutical industries, health care indust

est threat to the well deserved retirement and long life that the Baby Boomers envision. There is no cure for Alzheimer's disease. Perhaps the Baby Boomers will be able to conquer this dreaded

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

dictator.

Baby Boomers consider aging something that other people experience. This generation will not give up its vitality so easily. The Baby Boomers run marathons, eats healthy and are in

.

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

over all better shape than their parents. Baby Boomers are also some of the wealthiest individuals. The Baby Boomer generation will not go “gently or quietly into that good night”. The over

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

Companies that provide selfless information through particip

riding legacy of this generation is their optimism for their future. That optimism includes a future without Alzheimer's disease.
=======================================================

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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