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What two words do Bigfoot researchers revile more than any others? Paranormal and supernatural. But why

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

do these two words stir up so much anger and angst?

"Don't call Bigfoot paranormal!" the rant goes. "

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

Examples of combination products may in

The Sasquatch is a flesh-and-blood animal, not some supernatural boogeyman."

Yet, as I've discussed be

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

fore, the word paranormal means simply "not scientifically explainable." A giant, bipedal creature—whet

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

her you call him an ape or a hominid—wandering the backcountry of our world does defy accepted science.

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

Combination pro

Their very existence makes Bigfoots scientifically unexplainable and, therefore, paranormal. I conside

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

r Bigfoots very much flesh-and-blood animals. Yet they are also paranormal; one does not preclude the o

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

ther.

Paranormal and supernatural are essentially synonyms. Supernatural means "departing from what is

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

usual or normal esp. so as to appear to transcend the laws of nature." You might ask how a flesh-and-b

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

lood animal could transcend the laws of nature. But wait—there's one little word in that definition tha

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

t makes all the difference. The word is "appear." Something supernatural appears to transcend th

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

Following aspects would a

e laws of nature. Appearing to do something and actually doing it are two different things.

The meat o

dd to the challenges in developing combination products:

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

f the definition states that a supernatural event or being departs from what is usual or normal. A hair

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

y, bipedal creature definitely departs from the normal. We can only guess wildly about how many Bigfoot

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

s live in any particular area, which means we have no evidence of how the species survives. Do they hav

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

e a large enough population to procreate without detrimental inbreeding? We don't know. Bigfoots appear

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

Professional from academic institutions, pharmaceutical industries, health care indust

to survive without a large population; therefore, they appear to transcend the laws of nature. That sa

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

tisfies the definition of supernatural.

Once we understand what words mean, they cease to have power o

.

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

ver us. For words have no power of their own—they possess only what power we ascribe to them.

Defin

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

Companies that provide selfless information through particip

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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