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E-Articles - Is Your Comfort Zone Holding You in a Torture Chamber?
What a weird title for this article, isn’t it? How could that ever be?
We are talking about the cushy, fluffy, fleece-lined personal comfort world here. The temperatu
We are talking about the cushy, fluffy, fleece-lined personal comfort world here. The temperatu
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
re is set just right to keep you in a “safe place” lull till the cows come home. In cow-speak it means forever. It feels so yummy and smooth there…without even asking
; 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
for much.
Have you ever noticed how many times a day (lately it’s like a constant) we hear ourselves or others saying how everything is stressfully speeding up and th
Have you ever noticed how many times a day (lately it’s like a constant) we hear ourselves or others saying how everything is stressfully speeding up and th
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ngs are changing from one minute to the next? What used to work and apply beautifully at dawn is a garburator-shredded old way going down the sewer at dusk!
And, how
And, how
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
about ‘them’ computers? Your purchase of one from yesterday has left you with an “Update To The Most Recent Version” Dialogue Box on your screen first thing this morni
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 when you fired it up. Have you had this happen to you?
You probably already know exactly what we are talking about and where we are going with this.
To keep up bey
You probably already know exactly what we are talking about and where we are going with this.
To keep up bey
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
ond the Jones in a comfortable way, we need to “Update” ourselves just like everything else is ‘updating and changing away’ in the Universe neighborhood.
Your ‘Intern
Your ‘Intern
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
al Software Update’ can easily be done on a keen-student and as-you-go basis. A more radical, stressful and no-mercy way happens when the mad-cows “don’t come home ” o
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e day. To top it off, the sacred pasture is gone as well?
What if you don’t ask for much, but one day, your world rudely asks for much more from you?
The wise man on
What if you don’t ask for much, but one day, your world rudely asks for much more from you?
The wise man on
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
ce said, “There is nothing stressful, but thinking makes it so.”
See, even that truth can be ‘updated’ today into “thinking and feeling make it so”.
“You’ve hurt my
See, even that truth can be ‘updated’ today into “thinking and feeling make it so”.
“You’ve hurt my
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ogic!” vs.” You’ve hurt my feelings!” Which one have you heard before?
It’s all in the feelings, too, isn’t it? They are as part of your ‘comfort zone’ as you are par
It’s all in the feelings, too, isn’t it? They are as part of your ‘comfort zone’ as you are par
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
t of this world today.
You know your feelings are powerful. One moment, they can keep you celebrating in the Magical Turret of your castle with a view. In a split of
You know your feelings are powerful. One moment, they can keep you celebrating in the Magical Turret of your castle with a view. In a split of
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
a second, they can keep you in the torture chamber down below, chained up to the cold rock wall for what seems eternity.
What separates the two places is a single ha
What separates the two places is a single ha
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
lway, a set of steps down and one set going up. Not much, really. You can tell. Now, where do you want to spend most of your time?
Our personal beliefs, emotional in
Our personal beliefs, emotional in
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
telligence, understanding, common sense and decency may be in an acute need of “Updating” way before we press the alike-function button on our computers.
Amazingly, a
Amazingly, a
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
lot of people will choose the “Self-Update Much Later” button and will not even want to understand the reason ‘why’ anyone would want to do such a thing. The ‘torture
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
room’ experiences are not strong enough motivators for them at the time.
If you are aware and want more from life now, your choice here is clear.
Update - Renovate –
If you are aware and want more from life now, your choice here is clear.
Update - Renovate –
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Refresh – Re-draw – Re-kindle – Ditch & Discover – Humble up – Build up – Lose-To - Appreciate – Attract - Fortify & Soften, and do whatever it takes to keep yourself
.
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
up there in the Turret of your castle with a view and … good friends, too.
All of your willingness & effort today armor you with a new empowering instinct for tomorro
All of your willingness & effort today armor you with a new empowering instinct for tomorro
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
w!
It’s rare, but possible.
Unlike the rest, you will so develop fresh habits to cling to that eventually do NOT hurt!
Copyright 2005 Di & Lu, www.gladiatorsouls.co
It’s rare, but possible.
Unlike the rest, you will so develop fresh habits to cling to that eventually do NOT hurt!
Copyright 2005 Di & Lu, www.gladiatorsouls.co
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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