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Main Subject - Change, Growth And The Life Cycle (2)
... According to Erikson, each stage has a development task and a person should resolve this task before he can move forward
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
to a next phase ...
Alexander writes: "Consider the case of a young couple and their new born child. The child “depends”
Alexander writes: "Consider the case of a young couple and their new born child. The child “depends”
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
on the parents to give the care and love that is required to resolve the conflict of trust that goes with infancy. But simulta
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
neously, the child gives the parents the experience of raising and bearing, which helps them to meet their conflict of generati
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
vity, unique to adulthood."
This is why Alexander -- an Architect -- uses this theory of Erikson to establish his community pa
This is why Alexander -- an Architect -- uses this theory of Erikson to establish his community pa
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tern. A community pattern is to solve a community problem; “make sure that the full cycle of life is represented and bal
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
ance in a community.” Because people will (have to) meet the conflict of their stage when they are confronted with people of ot
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
her stages ... “Babies control and bring up their parents, as much as parents bring up their children.”
If different groups o
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
f people live in isolated communities -- the retirement villages, teenage cultures, college towns, they will not be able to mee
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
t the conflicts of their stage. The conflicts between children and infants, or between adolescents and adults.
Changes in life
Changes in life
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
become apparent when we can look back, or to others and notice that we have been there, dealing with similar issues. And realiz
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ing that now we have different issues to confront, part of the stage we are in.
But we are not always able to shut the door be
But we are not always able to shut the door be
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
hind us. Alexander pictures a sixty-year-old woman wearing bright red lipstick on her wrinkles, they cling ferociously to wh
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
at they never fully had.
Check for yourself how you have solved the challenges in the different stages of your life. Look
Check for yourself how you have solved the challenges in the different stages of your life. Look
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
back and see how you have grown up. And compare this with other changes in your life, or at work. And ask yourself -- have I so
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
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
ved the problems that are part of this transition, or am I still struggling with the demands from the old situation and not abl
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
e to dedicate my time and life on the new challenges? We see this often in business -- for example the manager that is still ma
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
naging like a specialist, because that is where his growth stopped. He is not able to fulfill the change from one stage to the
.
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
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
other.
And this is what happened to the couple that visits the marriage counselor. Although they had become parents they were
And this is what happened to the couple that visits the marriage counselor. Although they had become parents they were
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
still struggling with problems from previous stages. And therefore not being able to manage their marriage ...
© 2006 Hans Boo
© 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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