Main Subject - Business

... Once there was a couple with serious problems in their marriage. They asked the advice of a counselor in a last attempt to resolve their conflict. Aft

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

er some sessions, the counselor confronted the couple with the bottleneck; a difference in emotional age between the two. It appeared that one had the emo

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

Examples of combination products may in

tional age of 18 whereas the other’s emotional development got stuck in early childhood. The couple was married for quite some years, had become parents a

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

d their children were soon to leave home ...

...

Life is (not) a moving staircase where you move gradually from one level to another without noticing it

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

. Sometimes it looks like that, but in order to manage change we need to be aware that the different levels are not accessed without taking a step that br

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

Combination pro

ngs you to the next level as in a game, where each level has its own difficulties and challenges.

Everyone can recognize the fact that a person’s life tr

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

averses several stages -- infancy to the old age, writes Christopher Alexander in his twenty-sixth pattern (A pattern language) called “life cycles.” Eac

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

stage is a discrete reality -- according to Alexander – with its own special compensations and difficulties. He quotes Erik Erikson, a Danish psychologis

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

t who has categorized these (eight) stages in the life of a human being:

The infant that deals with trust vs. mistrust. The relationship betwe

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

n the infant and the mother. The struggle for confidence that the environment will nourish.
The very young child. Autonomy vs. doubt. The relati

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

onship between the child and parents. The challenge to stand on one’s own feet in the experiences of shame and doubt.
The Child. Initiative vs.

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

Following aspects would a

guilt. The relationship between the family and friends. Search for action and construction checked by fear and guilt of own aggressions.
The y

dd to the challenges in developing combination products:

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

ungster. Industry vs. inferiority. Relationships to the neighbourhood, school.
Youth. Identity vs.identity confusion. Relationships to peer and

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

“outgroups” and the search for models of adult life.
Young adults. intimacy vs. isolation. Partners in friendship, sex, work. The struggle to

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

ommit oneself.
Adults. generativity vs. stagnation. The relation between a person and the division of labor, and the creation of a shared house

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

hold. The struggle to establish and guide versus the feelings of stagnation.
Old age. integrity vs. despair. The relations between a person and

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

Professional from academic institutions, pharmaceutical industries, health care indust

his world. Acceptance of one's life versus the despair that life has been useless.

According to Erikson, each stage has a development task

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

and a person should resolve this task before he can move forward to a next phase. As mentioned by Alexander -- these stages are discrete realities. We ne

.

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

d to make sure that we are aware when we finish one stage and when we enter a next stage. Each stage has its own difficulties and compensations. If we do

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

Companies that provide selfless information through particip

not manage to overcome the difficulties of one stage, will will not be able to manage the challenges of the next stage.

To be Continued.

© 2006 Hans Boo

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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