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Main Subject - Feed Em Back Their Arguments!
Does this symphony sound familiar?
You are too!
Am not!!
You are TOO!
AM NOT!
YOU ARE ALSO!!
AM NO
You are too!
Am not!!
You are TOO!
AM NOT!
YOU ARE ALSO!!
AM 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!!
Familiar? It's how kids argue. I'm sure you've tried this mode of arguing decades back.
Children, when po
Familiar? It's how kids argue. I'm sure you've tried this mode of arguing decades back.
Children, when po
; 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
nted out that they are "xxx", tend to retaliate that their accuser is also "xxx" The accuser then balks, becaus
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
people hate having their arguments thrown back at them. It's human nature.
The Reflexivity Principle applies
The Reflexivity Principle applies
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
his known fact. By applying a belief statement back to the person asserting it, we test the applicability of th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t belief within an equitable context. By equitable context, I mean that what's good for the Gander should also
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
be good for the Goose. This determines the universality of the statement. If, by throwing an argument back to i
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
s issuer, we observe a resistance, then this could indicate a presence double standards. This surely makes the
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
rgument IRRATIONAL, and NON-UNIVERSAL.
You've successfully countered his argument.
Let's see this in play.
S
You've successfully countered his argument.
Let's see this in play.
S
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
e says, " You're always with your officemates. Obviously you don't like me anymore"
To counter this, you apply
To counter this, you apply
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
her argument back to her by saying, "My dear, you spend at least 3 hours a day with your friends after work. Do
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
es this imply that you love me less now as well?"
She will then see the irrationality of her argument.
Let's
She will then see the irrationality of her argument.
Let's
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
ry another.
Mark says, "The Bush Administration wastes so much time bickering, debating and arguing. Obviously
Mark says, "The Bush Administration wastes so much time bickering, debating and arguing. Obviously
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
this country is going nowhere. Such a waste of time!"
So you come to the good ole US of A's defense by saying,
So you come to the good ole US of A's defense by saying,
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
"I see.... so shall I assume that your business will never prosper either? Your Board spends a lot of time deli
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
erating and debating. I observed that you, as Chairman, even seem to enjoy this and you goad them on! Now despi
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
te all that bickering, your company grows 10% per annum. Mark, I'm sure you're already aware of the value of de
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ate. Healthy deliberation illuminates multiple avenues of action. That's what your Board does. That's what 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
ush administration accomplishes."
Okay, let's put this to practice. Someone brave, come to the front; voluntee
Okay, let's put this to practice. Someone brave, come to the front; voluntee
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
10 arguments.
Then let's have someone else come up with ten counter arguments using this principle.
Have fun
Then let's have someone else come up with ten counter arguments using this principle.
Have fun
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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