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In the late sixties, the youth of the West became enraptured with the concept of peace. John Lennon captured these times with the si

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

mple messages of 'all we are saying is give peace a chance' and 'war is over if you want it'. However although the peace movement co

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

Examples of combination products may in

ntributed significantly to the ending of the Vietnam War, thirty years later we find that many young people are actually quite cynic

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

al about the possibility of global harmony ever taking root on earth. Part of the problem is that, at the moment, approaches to achi

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

ve world harmony are applied from the top down, in the form of grand ideas and concepts which everyone is then expected to live up t

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

Combination pro

o. These ideas seem to offer a panacea to all troubles, and for a while they generate a great deal of enthusiasm. However, due to va

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

rious reasons such as leaders not living up to the ideals they espouse, people become tired and prefer to concentrate on their own p

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

ersonal lives rather than aspire for such abstract notions as world harmony.

This doesnt mean that a harmonious world isn't possibl

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

; it just means that to achieve it we have to try and approach it from another angle. An alternative approach is to start from the 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

ottom up, with one person at a time. Outer peace can only reign on earth when each one of us has abiding inner peace, free from the

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

insecurities and desires for supremacy that fuel conflict. Put quite simply: 'The answer to the problems of this world is for ev

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

Following aspects would a

ery one of us to go beyond our present capacities and become better citizens of the world' (1)

One person may seem very small,

dd to the challenges in developing combination products:

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

but like waves rippling in a pond after a stone has been dropped in it, the effects of one person's change for the better can affect

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

all around them. The twentieth century alone can point to many examples such as Nelson Mandela, Mikhail Gorbachev and Mother Teresa

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

. You might say that your actions would be insignificant compared to theirs, but an interesting quote in a book I read recently went

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

'Even in a seemingly losing cause, one person may unknowingly inspire another, and that person yet a third, who could go on to

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

Professional from academic institutions, pharmaceutical industries, health care indust

hange the world... '. (2) In addition, great people did not suddenly become great people as a result of the situation they face

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

d; they had developed those qualities beforehand, far away from the public eye. And on the strength of their personal example, lumin

.

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

aries such as these brought us far closer to the goal of world harmony than all the grand concepts and ideas that had gone before th

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

Companies that provide selfless information through particip

em.

References:

(1) Sri Chinmoy, Seventy Seven Thousand Service Trees

(2) Paul Rogat Loeb, The Impossible Will Take a Little Whil

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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