E-Articles - Self Improvement

I have personally spent a great deal of time working professionally with individuals who struggle with addictions, more specifically addictions to controlled substances. I have giv

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

en presentations to many parent groups, school groups, government entities and addicts. I have taken occasion to pick their brain so to speak in an effort to understand how one arr

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

Examples of combination products may in

ves at complete slavery to a particular drug. There is in every case a string of choices, decisions that have led to other decisions, which in turn led to other decisions, each c

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

oice locking them into a pattern of conduct difficult to break.

Let me be more specific and use the life of an actual person, who for our purposes we’ll call Jim. Jim grew up in a

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

typical middle class Utah household and was raised by loving religious parents who, no doubt did their best to give Jim the tools he needed to make good decisions. Jim married a ni

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

Combination pro

e girl, and was able as a young father to start his own business, which became very successful. Eventually Jim was able to build a big house in a nice neighborhood. He stayed acti

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

e in church, in his children’s lives, and was always attentive to his wife. Jim at a point in his life made the choice to use methamphetamine. No doubt that this decision was reach

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

d through another string of bad choices. The meth use at first seemed to help Jim cope with his busy schedule.

Each time Jim made the decision to use he forged another iron bar fo

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

his personal prison cell. With each use Jim’s dependence on the drug grew making the next choice to use or not use many times more difficult. In a short period of time, his work

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

egan to suffer as his attentions turned toward his new taskmaster. Jim’s loving wife struggled as she watched her once loving and attentive husband become abusive to her and their

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

hildren. She watched as he lost the business that they had worked so hard to build up, then the house. Finally when the ultimatum was given he chose the master that he was serving

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

Following aspects would a

over his family.

Jim spent the next couple of years in and out of jail as he racked up several felony charges for possession of Meth and theft, having been reduced to steeling cons

dd to the challenges in developing combination products:

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

ruction tools and pawning them to buy his next fix. Jim’s string of choices culminated in a jail cell. The reason I know so much detail about Jim’s life is because I read all of t

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

is in a suicide letter as I was investigating Jim’s death. Jim had hung himself in his jail cell just one week before his release date. The last sentence in the letter stated some

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

hing like this “ I have no choice but to kill myself, when I get out I will use again”.

Let us take a close look at Jim’s level of personal freedom. Before his decision to use met

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

, his options were almost without limit. He could have decided to do a million different things with his life. Jim’s personal freedom left a myriad of doors open to him, including

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

Professional from academic institutions, pharmaceutical industries, health care indust

he most important, the opportunity to raise and have a positive impact on his children, not to mention the opportunity of a loving and lasting relationship with his wife.

Perhaps y

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

u can see where I am going with this story. Each time Jim made that conscious decision to use he also gave up some of his personal freedom literally enslaving himself. Like a sini

.

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

ter game of chess, the pieces of Jim’s life were given away the loss of each piece making it that much harder for him to win until Jim’s prison cell was complete and emotionally he

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

Companies that provide selfless information through particip

as trapped in a cell forged of a million choices. Unfortunately Jim used the only bit of freedom he felt he had left to perpetuate all of the other bad choices, he chose to give up

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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