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Useful Advices - Your Organization On The Couch
Take a moment and think about the following diseases; depression, paranoia, schizophrenic, dramatic or compulsive. If you do no
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
t come up with an example, you could think about Melvin Udall (Jack Nicholson in “As Good as it gets”):
... Melvin Udall ... s
; 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
ffering Obsessive Compulsive Disorder, or OCD. We all have concerns and routines or particular ways in which we do certain thin
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s, like the times we eat or the routes we take to work or the way we fold our clothes. When these behaviours ritualistic, howev
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
r, or thoughts become persistent and bothersome, we move into the realm of obsessive thinking and/or compulsive behaviour, stro
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
g indicators of OCD.
In analogy with human behavior, the style of an organization reflects the behavior of an organization. Ex
In analogy with human behavior, the style of an organization reflects the behavior of an organization. Ex
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
mination of this style is not often necessary, but it could serve a function; for example in the case when the organization is
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
o confront a new challenge. In that case a sketch or outline of the style could help to address the challenge with the followin
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
question; are we going to confront this challenge (change) in the same way we have always done, or will we invent a new approa
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
h.
Raising the question like might lead to a new question: “what is our approach anyhow?” Of course there is a more or less ac
Raising the question like might lead to a new question: “what is our approach anyhow?” Of course there is a more or less ac
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
epted approach in the way things “are done here”, but it is not easy to describe this.
A next question could also help. Is our
A next question could also help. Is our
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
style at least alright, or does the style of our organization resembles some kind of a mental disease? It is not the first thi
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
g to ask, but it helps the diagnosis. And organizations are just like humans; they visit a psychologist (only) after something
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
as happened, or when something is going ‘wrong’.
Interesting in this context is an inventory of dysfunctional styles that repr
Interesting in this context is an inventory of dysfunctional styles that repr
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
sent the unhealthy mental state of the leader of the organization. These styles has been described by Kets de Vries in - The
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
Neurotic Organization: Diagnosing and Changing Counterproductive Styles of Management The five organizational styles that a
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 described in the book are: paranoia, compulsive, dramatic, depressive and schizophrenic.
In “As good as it gets,” it was Car
In “As good as it gets,” it was Car
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
l who “cured” Melvin. But in real life, an organization can not be cured in the same way. But to understand the dynamics of an
.
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
rganization the five dysfunctional styles can help to analyze the behavior of an organization. This is perhaps not necessary un
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
er normal circumstances, but it could become appropriate when you sense an unhealthy organizational climate...
© 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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