Main Subject - Business

Our point of view, perception, and learning are all objects of our knowledge, and t

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

hese are things that prevent us from going ahead. "I already know everything there

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

Examples of combination products may in

is to know about that. I don't need to learn any more." We have arrived only at the

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

fourth rung of the ladder, yet we think it is the top rung. Whatever the value of

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

what our intellect and our insight has attained, we have to abandon it. If we don't

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

Combination pro

we put an end to further progress. Even though it has some value, our knowledge ha

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

s become an obstacle. If we are caught in our knowledge, if we say that our knowled

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

ge is absolute truth, we suffer from the knowledge-obstacle. Those who have knowled

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

ge but know that they have to abandon it in order to go further do not suffer from

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

the knowledge-obstacle.

Objects of knowledge are like water that has become ice an

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

prevents the river from flowing. We need knowledge, but we have to use it intellig

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

Following aspects would a

ently. If we think that our present knowledge is paramount, our way is blocked. Our

dd to the challenges in developing combination products:

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

knowledge has become an obstacle. We cannot [or should not] be attached to anythin

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

g; we have to abandon even our insight, our understanding, and our knowledge [to be

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

truly free].

Have you ever wondered sometimes the CEO of a company might not even

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

be experienced in a certain business that the Company is engaged in? The reason cou

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

Professional from academic institutions, pharmaceutical industries, health care indust

ld be that, for the CEO to be a visionary, he or she should not be suffering from t

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

he knowledge-obstacle.

You might not need to hire a new CEO, but you can always tr

.

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

ain your R and D team to understand that they have to abandon their knowledge and e

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

Companies that provide selfless information through particip

xpertise in order to go further, and thus not suffering from the knowledge-obstacle

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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