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One does not have to live long to realize that along the pilgrim’s path are many battles to b

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 fought and enemies to be overcome and we should not be surprised when new trials come our w

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

Examples of combination products may in

y. It does not matter how victorious we may have been in one battle, we cannot get too comfor

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

able because there will be other combats with other giants.

These other giants may not be as

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

big and colossal as Goliath, but they must be dealt with just the same. Sometimes Goliath co

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

Combination pro

es in the form of circumstances; sometimes he comes in the form of aggravating people; someti

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

es this giant comes in the form of overwhelming grief and despair. But perhaps the greatest a

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

nd most lethal giants we have to confront and keep under management come from within ourselve

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

.

We may have triumphed over outward circumstances, but the strain of the battle has left th

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

spirit embittered and broken, the zest for living gone from the heart. Perhaps you have been

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

left with the discouraging thought that Goliath rules and it is time to wave the white banner

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

Following aspects would a

of surrender. For Christians, this is not an option. We must fight. We will fight. We will f

dd to the challenges in developing combination products:

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

ght the good fight of faith. We will not go gentle into the grave of resignation and capitula

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

ion that Goliath has dug for us. Through the power of our omnipotent Lord, we will keep on

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

fighting until the victory is won.

I read a blog posted by Maja which was written November 1

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

, 2004. It is titled: The Bigger They Are, The Harder They Fall and describes the fall of Ara

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

Professional from academic institutions, pharmaceutical industries, health care indust

at. It brought to mind that the same is true of all believers trusting in God. We know that i

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

n Him, it is only a matter of time before Goliath will fall into the abyss of what was. Isn’t

.

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

it good news to know that the giants may keep coming but with Jesus on our side, the bigger t

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

Companies that provide selfless information through particip

ey are, the harder they fall? Go to God in prayer and then, LET THE GIANTS COME!

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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