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According to the dictionary, poison is a substance that causes injury, illness, or death; inhibits or retards reaction; has a harmful or dangerous effect. When one hears the word poison, one usually thinks of chem

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

ical substances such as arsenic, strychnine, opium, etc.

Actually we have several types of poison—that which causes injury, inhibits, cripples or is harmful to a greater or lesser degree. We have the poisons of t

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

Examples of combination products may in

e body, the poisons of the mind, and the poisons of the spirit.

Body poisons debilitate physical effectiveness. Mind poisons cripple constructive creativity and twist thought perception and imagination. Spirit po

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

sons impede if not warp personal relationships with God and our fellow men and women. It is difficult to categorize here for spiritual poison can inhibit mental growth; mental poison can retard spiritual developme

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

t; and physical poison, if strong enough, can stop the whole life process!

Now let’s substitute the word pollution for poison. Pollution is basically contamination by noxious substances. The body is polluted thro

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

Combination pro

gh the various oil, water and air contaminants. The mind is polluted through noxious obscenity and pornography, and through random and indiscriminate curiosity; the spirit is polluted through hates and resentments

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

We have read much through the years about pollution of body and mind, and necessarily so. But I would like to discuss a polluting agent of the spirit—and this is RESENTMENT.

Resentment of itself can be a necess

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

ry defense. C.J. Fox explains it well: “There is a spirit of resistance implanted by the deity in the heart of man proportioned to the size of the wrongs he is destined to endure.” The key word here is PROPORTIONE

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

. There are people who can take an innocent action or remark and develop it into a personal affront that requires a lifetime to avenge. There isn’t a person on earth who at sometime or other in his or her life won

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

t be hurt, frustrated or disappointed, but it takes character to evaluate and accept the situation for what it is and then forget it.

Actually resentment is the inability to forgive and forget. We’ve all met the

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

oor soul to whom life is a very raw deal; the whole world is taking advantage of him or her; and on and on, until we wonder why the person clings so desperately to life. This person has enough self-pity to cover h

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

Following aspects would a

imself and any leniency and compassion he might get from others. Soon he becomes such a crashing bore that no one sticks around to hear about the terrible injustices that life has meted out to him, and the imposit

dd to the challenges in developing combination products:

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

ons of relatives, friends and strangers. Then there’s more resentment and self-pity because the person feels ignored and slighted.

Dr. Maxwell Maltz, in his book PSYCHO-CYBERNETICS, points out the dilemma of this

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

type of personality. “The resentful person turns over his reins to other people. They are allowed to dictate how he shall feel, how he shall act.” This person is destined to be unhappy because he makes impossible

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

emands on others and then feels put upon, angry, and bitter when others can’t live up to his ultimatums.

Resentment is too quick to sit in judgment and too reluctant to overlook the sins, intended or not, of 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

s. The bitter person tends mentally, if not verbally, to impose a debt on the transgressor (mostly unfair) that must be paid before the wrong-doer is restored to friendship and acceptance once again. It’s a subtle

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

Professional from academic institutions, pharmaceutical industries, health care indust

and cruel form of emotional slavery, and it doesn’t take much thought to see who is hurt most.

The honey bee, when it stings, brings temporary pain to its victim, but death to itself. That’s the sum of it for us,

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

too, when we refuse to forgive and forget: our spirit dies just a bit more until we are finally in the killing throes of bitterness and hate, and thus unable to see the good and constructive in anything or anyone.

.

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

Here’s wise advice I once read, for any who would let resentment poison the spirit: “It has been said that a man, like a tree, is best measured after he has been cut down. Please reserve judgment. Time will softe

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

Companies that provide selfless information through particip

your views and diminish your anger. Remember that hate, like acid, does more damage to the vessel in which it is stored than to the object on which it is poured” (Anonymous).

Published in Healthways and Pen Woma

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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