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With the advent of globalization, there has been great increased in the recent few years in the knowledge manag

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

ement. Knowledge management involves mining and integration of huge and scattered knowledge into a single platf

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

Examples of combination products may in

orm, to generate knowledge intelligence. Intelligence analysts are the knowledge workers most important tasks.

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

Analysts must sift through massive amounts of data, using perspective gained from history and experience to pul

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

l together from disparate sources the best coherent picture of what is happening in a technical domain. Informa

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

Combination pro

tion Technology research has the potential to create innovations, which is very essential in this competitive e

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

nvironment. Analysts make heavy use of precedents and analogies. This sometimes leads to vital “trans-logical”

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

leaps.

Precedents and analogies both sometimes increases and reduces the quality of the analytic product. Bet

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

ter use of human intelligence, along with various knowledge-based software power tools could help the analysts

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

in recognizing the deeper or less obvious analogies and apply these analogies to the current technical trends,

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

and generate best technical ideas.

The knowledge workers make heavy use of scenario generation, both to interp

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

Following aspects would a

ret current technical and market trend and to project plausible future events to expect or guard against.

The

dd to the challenges in developing combination products:

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

increase in global patent protection more and more companies are looking at IP from a business as well as a leg

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

al perspective. Thus it is essential to have a patent due diligence before entering a new market. Patents have

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

being considered as the most important source of technical knowledge. If you know what your competitors are doi

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

ng, you can align your strategic goals accordingly. Computation patent mapping, which most of the companies are

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

Professional from academic institutions, pharmaceutical industries, health care indust

using is a methodology for the development and application of a technology knowledge base for technological, s

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

trategic and competitive intelligence. Patent maps are categorized representations of patent information that h

.

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

as been mined and aggregated or clustered to highlight specific features. All these operations are performed by

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

Companies that provide selfless information through particip

knowledge workers either within the companies or through various knowledge outsourcing service (KPO) providers

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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