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Chemical Addiction is mainly an adult disease with a childhood onset. Why an adult disease? Because of its progressive nature, addict

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

ion does not usually become so problematic and disturbing to a person's life until its later stages. By then the victim has reached a

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

Examples of combination products may in

dulthood. At that point family life, relationships, job and even health begin to falter due to the addiction, regardless of the drug

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

of choice. The "drug of choice" can be most any addicting substance including alcohol, marijuana, cocaine, methamphetamine, heroin an

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

narcotic prescription medications.

Why childhood onset? Recent science has revealed two very important truths. First, addicting sub

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

Combination pro

stances including alcohol and tobacco cause intense stimulation of the pleasure center of the brain by releasing dopamine, an importa

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

nt neurotransmitter. Second, the more immature the brain stimulated, the more likely the brain will be permanently altered (toward ad

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

iction). Considering the fact that the average human brain does not reach full maturity until the mid-twenties, it is easy to see tha

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

t youngsters are at great risk for addiction because the average age of the first drink of alcohol is only 13 years of age.

What doe

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 this mean in day-to-day living? As our children are using tobacco, alcohol and other addicting substances much earlier than we thin

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

, many of them are well into transition to full blown addiction before many parents realize they are even experimenting. Consequently

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

Following aspects would a

, when we discover their use because of "red eyes", a DUI or finding a joint, they well past the timeframe that effective prevention

dd to the challenges in developing combination products:

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

can be implemented.

What is the connection between early alcohol and tobacco use and the decision by kids or adults to use drugs? On

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

ce the immature brain has been permanently altered by exposure to alcohol or tobacco, the choice to move on to addicting drugs like m

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

rijuana, cocaine, heroin, Oxycontin and methamphetamines is an easy one. The social taboos against drugs and the fear of danger are 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

otally erased from this altered young, addicted brain.

Many believe that addiction is a matter of fate or even a single gene. While

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

Professional from academic institutions, pharmaceutical industries, health care indust

there are some racial, ethnic and geographic differences in addiction rates, virtually no American can claim that he or she hasn't at

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

least one relative with an addiction. Therefore, all children are potential adult drug addicts later in life. Fortunately, as parents

.

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

, educators and professionals, we don't have to sit back and just hope that our children will grow up to be sober citizens. There are

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

Companies that provide selfless information through particip

practical concepts and techniques to make to possible to proactively insure that your child will not become an addict or an alcoholi

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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