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So often people will do just about anything to join a group or receive social ac

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

ceptance, but they fail to realize what they are giving up to do just that. Once

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

Examples of combination products may in

they surrender their "self" and belief system to the group, the group then mold

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

s them to suit their agenda or mission.

It is truly unfortunate that people the

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

se days have such low self-esteem that they just cannot resist the temptation of

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

Combination pro

accolades and support from the various social groups that they join. One should

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

never join a group or stay in a group if they see that they are required to alt

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

er their points of view or disregard and deny their observations and actual expe

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

riences in trade for social acceptance. Beware if you see this happening.

You h

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

ave a choice and you do not have to join such organizations, so either you are a

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

leader or follower - so think about it. Whether it is a business club, religiou

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

Following aspects would a

s organization or recreational club, you must consider how much your "Self" is w

dd to the challenges in developing combination products:

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

orth. There is indeed a lot to be said for Social Acceptance, Organizations, Cho

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

ice and Personal Observations and if you start trading one for the other, you mi

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

ght have to look in the mirror and ask yourself; "What have I become?"

Usually

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

people in groups do not even realize what is being done or the social engineerin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g tactics that are occurring, often the group itself does not even mean to do it

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

- it just happens because of the natural and normal occurrences of social inter

.

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

-action. Much of this is merely part of the human dynamic and innate characteris

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

Companies that provide selfless information through particip

tics of the species. But, I warn you to keep your eyes open and consider it all.

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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References - Social Acceptance, Organizations, Choice and Personal Observations

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