Summary - Reference and Education

Many people believe that those with large heads are smarter than the rest of the humans on th

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

e planet. This is not always true, but sometimes it is and is very noticeable in observation

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

Have you ever met someone with a large head who really was smarter than everyone else?

Ind

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

eed, I have and as a studier of human nature I have noticed that people with larger heads are

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

generally smarter than other people. This does not mean that people with skinny heads are not

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

smart. I have also met people with smaller heads who are just as smart or brainy. It appears

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

that people with large cranial capacity and bigger heads have the opportunity to become smar

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

if they apply themselves.

Just because someone has big arms does not mean they are strong.

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

Muscle strength comes from working out and using those muscles. It's like that old adage;

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

strong>"Use It or Lose It!"

That may be truer than we have come to realize. Your a

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ility to think, reason and come up with original thoughts has a lot to do with what you think

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

about and how much you use your brain.

For those people who turn off their brain and stop u

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ing it, well it probably does not matter if they have a big head or a small head because it i

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

s a waste of cranial space. One of the people in the world with the highest IQ has a larger t

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

an normal head size and he believes that perhaps this has helped him become smarter than othe

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

humans.

He may or may not be right and yet it stands to reason that he is, of course if he

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

doesn't use his brain to do complex thinking then he will become ignorant overtime. Luckily

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

his individual spends a lot of time thinking on complex issues and problem solving. With a b

.

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

igger head size and a larger cranial capacity indeed he would have the potential if he contin

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ally worked out his brain, just like you would at the gym to become stronger and build muscle

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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Summary - Cranial Capacity Theory

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