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Advice You - The Mathematics of a Firefight
When you examine the mathematics of a firefight, it’s easy to see why the big company usually wins. Let’s say that
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
the Red squad with nine soldiers meets a Blue squad with six. Red has a 50 percent numerical superiority over the B
; 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
ue. 9 versus 6. Or it could be 90 versus 60 or 9000 versus 6000. It makes no difference what the number are, the pr
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nciple is the same.
Let’s also say that, on the average, one out of every three shots will inflict a casualty.
Af
Let’s also say that, on the average, one out of every three shots will inflict a casualty.
Af
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ter the first volley, the situation will have changed drastically. Instead of a 9 to 6 advantage, Red would have a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
to 3 advantage. From a 50 percent superiority in force to a more than 100 percent superiority.
The same deadly mu
The same deadly mu
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
tiplication effect continues with the passage of time.
After the second volley, the score would be 6 to 1 in favor
After the second volley, the score would be 6 to 1 in favor
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
of Red.
After the third volley, Blue would be wiped out completely.
Notice how the casualties were divided betwe
After the third volley, Blue would be wiped out completely.
Notice how the casualties were divided betwe
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
n the two sides. The superior force (Red) suffered only half the casualties of the inferior force (Blue).
This res
This res
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
lt may be just the opposite of what you have been led to believe by all those Hollywood movies-the handful of marin
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s decimating a company of Japanese before the marines are finally overrun.
In real life it’s different. What happe
In real life it’s different. What happe
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
ns when a Volkswagen Beetle hits a GMG bus in a head-on collision? You wind up with a few scratches on the bumper o
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
the bus and a very thin German pancake. (The bigger you are, the harder they fall.)
The two vehicles have exchang
The two vehicles have exchang
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
d momentum. It’s a basic law of physics. The larger, heavier vehicle sustains less damage than the smaller, lighter
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
force.
There’s no secret to why the Allies won World War II in Europe. Where the Germans had two soldiers, we had
There’s no secret to why the Allies won World War II in Europe. Where the Germans had two soldiers, we had
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
four. Where they had four, we had eight. The skill and experience of an enemy who had practically invented modern w
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
rfare and the leadership of men like Rommel and Von Rundstedt could not change the mathematics of the battleground.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
In the military, the numbers are so important that most armies have an intelligence branch known as the order of
.
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
attle. It informs commanders of the size, location, and nature of the opposing force. (The case of General William
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
. Westmoreland against CBS was based on whether order of battle documents in the Vietnam war were falsified or not.
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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