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Those who are not in favor of systematic approaches and methods should read about this way to

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

facilitate the communication process.

Communication is a very wide area, but normally include

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

Examples of combination products may in

the process of a group of people that are exchanging ideas or thoughts. Now, how would you st

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

ucture such a process? Imagine that there are eight team members of which you would like to k

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

ow the individual opinions. People get easily influenced in a discussion. Sometimes your opin

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

Combination pro

ion is not finished, but being assembled as you go through an (interview) process.

Also for t

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

e sake of the team you do not want an individual opinion make that others keep quiet, because

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

hey do not quite agree. The communication market is a market like any others with a demand and

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

supply side. And too much supply of a single opinion will get the communication unbalanced.

I

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

n such a case where individual opinions are important, the diversity and variety of feedback i

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

needed you should make the individual input anonymous.

Then, when every team member could gi

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

Following aspects would a

e their personal input irrespective of what others have uttered (even without knowing this) yo

dd to the challenges in developing combination products:

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

are ready for a first group feedback. Again, you present the group results in an anonymous wa

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

y; not letting know who has said what. Then, based on your own input and what you observe as a

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

ditional feedback from your colleagues you are offered a new round to reply. Having seen other

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

opinions you can separate your input from these or as you are convinced that the majority wil

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

Professional from academic institutions, pharmaceutical industries, health care indust

be right you can connect to the consensus that is being formed.

Doing so requires an ambienc

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

e in which each respondent is able to provide anonymous input, an independent facilitator who

.

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

s steering this process and a few rounds to get an opinion which is shared by the group.

And

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

Companies that provide selfless information through particip

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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