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Over my thirty years in the polygraph business I’ve heard many negative comments about its effectiveness and accuracy. And it always seems that t

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

hese comments always come from people who have absolutely no direct knowledge of polygraph and how it works. This negativity comes from congressm

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

Examples of combination products may in

en and senators, judges and state legislators and many other folks who have never even seen a polygraph examination administered, much less exami

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

ed any studies performed by some of the most reputable institutions of higher learning and governmental agencies in this country.

I remember whe

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

n I first was asked by my boss at the Alabama Bureau of Investigation if I would like to attend polygraph school I had absolutely no knowledge of

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

Combination pro

polygraph. He told me the U.S. Army had just relocated their military police school to Fort McClellan, Alabama and with it, their polygraph schoo

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

l. I told him I would like to attend, mainly because it seemed he thought it would be a good idea.

When I arrived at the school, which is now kn

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

wn as the Department of Defense Polygraph Institute, in August, 1976, I was completely in the dark as to what I was about to experience. After a

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

couple of weeks of learning the basics of how polygraph works and learning how to operate the equipment we began testing soldiers. The thing that

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

makes this school unique is that they have an endless supply of people to learn how to test on. Each morning they would bring ten soldiers over t

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

o the school. There were ten students in my class, so we each had a person to conduct a test on. They would take two or three of the ten soldiers

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

Following aspects would a

and create a “mock” crime for them to have committed. This included things like a robbery, theft, etc. It was our job as students to conduct tes

dd to the challenges in developing combination products:

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

s on them to determine who was guilty. This testing never ceased to amaze me how we students “rank novices” that we were, would invariably come u

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

p with the right answer every single day. To this day when I hear some nay sayer knocking the accuracy of polygraph I wish just one of them would

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

go and witness how miraculous this system really is.

According to the American Polygraph Association over 250 studies have been conducted on the

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

accuracy of polygraph testing during the past 25 years. Based on the studies now available, experts have determined the accuracy of polygraph ex

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

Professional from academic institutions, pharmaceutical industries, health care indust

minations administered by a competent examiner to be about 90%. The level of skill and experience of the examiner plays a key role in the accurac

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

y of the examination. Comparative studies have also shown that polygraph examinations yield an accuracy that equals or exceeds that of many other

.

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

forms of evidence. In fact, in one study it shows that polygraph examination produced an accuracy that was comparable to results obtained by docu

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

Companies that provide selfless information through particip

ment examiners and finger print analysts, and exceeded that of eyewitnesses. Most errors in polygraph can be blamed for an inexperienced examiner

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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