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When King David was old and well advanced in years… Adonijah… put himself forward and said, "I will be king." I Kings 1.

David was a great King

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

who had ruled Israel with an iron hand for 40 years. But, time had caught up with him. Things the old king use to do, he could not do anymore. And so, the he

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

Examples of combination products may in

ll hounds came out of the cracks and crevices.

This is an interesting story about David because he had grown old and in his old age he had lost his usefulnes

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

as interpreted by others. King David had lost his sexual desire; he had lost his virility, lost his stature, lost his position as being “manly.” So his son,

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

Adonijah said, “I’ll be king.” Daddy isn’t what he use to be; he’s old, he’s senile, he’s done with, I’ll take over and I’ll rule.”

Well, when we contemplat

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

Combination pro

our society and nation today, all indications seem to suggest that our usefulness is predicated entirely on our ability to perform. What a sad commentary. It

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

seems as though we have a sort of built in self-destruct mechanism because we in America have made a god out of youth. We have men and women struggling to av

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

oid growing old. Cosmetic surgery has escalated to an almost insane number. We resort to all kinds of strategies: liposuction, implants, diet aids, make-up,

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

nti-aging creams, hair clubs and anything else that promises to keep us young. We want to maintain our youthfulness and vitality.

As a consequence, we have o

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

ld women running around with young men and old men with young women. Many of us are frantically lost, caught up in the whirlwind of trying to stay young. This

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

is the kind of society we live in. We have made so much ado about age that we have become more and more fearful of the aging process.

Well, when we get there

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

Following aspects would a

, and if we live we will, the day will come when we will find ourselves in David’s shoes. If we hang around, don’t go anywhere, stay on the scene of life, we

dd to the challenges in developing combination products:

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

will grow old. We will not be able to perform the way we use to. So the question is, will we too be rejected, cast aside, ignored like most of our seniors tod

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

y? The day is coming when we will be sitting where David and millions of others have sat. What will be our plight when we too come to the last miles of the wa

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

y?

Father Time had caught up with David and his son was anxious to get him on out of the way. Isn’t it sad how some people will take advantage of the elderly

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

When you can no longer speak for yourself, think as fast, see as clearly or hear as keenly as you use to, folks will take advantage of your weaknesses.

But

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

Professional from academic institutions, pharmaceutical industries, health care indust

before judging too harshly, we must understand that all of us suffer with a king complex. There is a gravitational force from the winds of the world to push

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

the old aside and to become king ourselves. When we see others stumbling, and fumbling and forgetful, the king complex kicks in and we want to push them aside

.

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

get somebody who can do it better. We forget, or suppress or deny, that where they are is where we are heading. What we do to them today, others will do to u

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

Companies that provide selfless information through particip

s tomorrow.

Be patient with our seniors. They may not be able to walk, talk see, or hear like they use to, but give them a chance.

Your day is coming!

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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