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Social Space - Shoes Gone Astray
Dorothy lost hers. I forgot mine. My wife broke hers. I speak of shoes, of course.
So why are we all smiling?
Dorothy is that sweet little girl who broke in that bustin' b
So why are we all smiling?
Dorothy is that sweet little girl who broke in that bustin' b
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
ronco of a tornado, landing in Oz and inheriting magic ruby slippers from a dead wicked witch.
For most people, the story ends when Dorothy loses her precious slippers somewh
For most people, the story ends when Dorothy loses her precious slippers somewh
; 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
re over the scorching desert that surrounds Oz ... much like a Congressman loses his power when he flies out of Washington and crosses over the gridlock on the scorching mid-s
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ummer Beltway.
Just as a Congressman is bound to return to Washington sooner or later, Dorothy actually does return to Oz many times. In fact, there are dozens more books in
Just as a Congressman is bound to return to Washington sooner or later, Dorothy actually does return to Oz many times. In fact, there are dozens more books in
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
the Oz series featuring hundreds of almost unknown characters.
With or without the power of her ruby slippers, Dorothy makes her way back to enjoy a multitude of unbelievable
With or without the power of her ruby slippers, Dorothy makes her way back to enjoy a multitude of unbelievable
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
adventures with her favorite misfits.
Shoe lesson number one. When you lose your shoes, improvise.
I discovered my shoes were missing also while flying high in the sky.
Bac
Shoe lesson number one. When you lose your shoes, improvise.
I discovered my shoes were missing also while flying high in the sky.
Bac
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
k in my days as a consumer advocate, I was on my way to deliver a speech in Newfoundland, sharing the lectern with the Newfoundland Minister of Transportation.
Sitting comfor
Sitting comfor
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
ably in the airplane seat, my mind was bobbing aimlessly on an ocean of emptiness. Suddenly I broke out in a cold sweat as I realized I had forgotten my dress shoes at home.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
In fact, they were waiting faithfully by the front door, ready to greet me upon my return.
In a matter of seconds I torpedoed through one thought after the other:
Yikes! I'
In a matter of seconds I torpedoed through one thought after the other:
Yikes! I'
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
m wearing running shoes for an important speech.
I know, I can buy a new pair when I land.
Too late; the stores are already closed.
What about in the morning?
No, tomorrow
I know, I can buy a new pair when I land.
Too late; the stores are already closed.
What about in the morning?
No, tomorrow
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is Sunday and my speech is scheduled for 9:00 a.m.
90 seconds later, the cold sweat had miraculously been replaced with a single affirmation: "I will improvise"
The next mor
90 seconds later, the cold sweat had miraculously been replaced with a single affirmation: "I will improvise"
The next mor
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, I began my speech: "You might be wondering why I am wearing running shoes today. Well, it's about this petition here. When I'm done speaking, I'll be running door to do
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
or and I want every one of you to come running with me, too."
It was not the speech I had come to deliver, but it worked just as well. Better, in fact. My little "goof-up"
It was not the speech I had come to deliver, but it worked just as well. Better, in fact. My little "goof-up"
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
ecame a clever demonstration of action speaking louder than words.
Shoe lesson number two. When you forget your shoes, improvise.
My brother was getting married. We had jus
Shoe lesson number two. When you forget your shoes, improvise.
My brother was getting married. We had jus
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
witnessed the signing of the papers at their house, and they were rushing over to another place for the the ceremony. Don't ask!
As we locked up their house, my wife's sand
As we locked up their house, my wife's sand
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
al broke. She tried walking in it, but to no avail. So off to the nearest shoe store we flew – figuratively, that is. This is not another story about losing shoes hundreds
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
r thousands of feet above a desert or a traffic jam.
We knew they would wait for us before starting the ceremony. What we did not know is how long they would wait.
That day
We knew they would wait for us before starting the ceremony. What we did not know is how long they would wait.
That day
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
my wife performed a miracle that no other woman has done before or since. She went into the store and came out just five minutes later with the perfect pair of sandals – sma
.
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
shing to smithereens the old woman-shopping-for-shoes Olympic record!
Shoe lesson number three. If you break your shoes, improvise.
Perhaps the most important lesson here is
Shoe lesson number three. If you break your shoes, improvise.
Perhaps the most important lesson here is
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
that, contrary to popular belief, the shoe does not make the man (or woman). But the lack of shoes sure can build character.
And it gives us a great opportunity to improvise
And it gives us a great opportunity to improvise
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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