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I was watching her. Sometimes, she was giving a faint smile. Then she

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

started looking at the ceiling and then started changing her feet posi

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

Examples of combination products may in

tion while sitting. After that she was sitting still for some more tim

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

e. Then she got up and left the room.

Do you also observe your partne

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

r carefully? What do you know about what might be going in his/her min

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

Combination pro

d? Can you predict about her thoughts? Many of us believe that we know

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

about our partners and that we are very close. But if your partner si

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

tes across you and thinks of something with matching body movements, w

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

ould you be able to guess about what was in his/her mind? I bet, most

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

of you will fail. I feel very sad saying this, but the truth is that m

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

ost of us will fail. Why don’t you ask your partner to predict about w

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

Following aspects would a

hat is in your mind? You will find out yourself. This is tragic for ou

dd to the challenges in developing combination products:

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

r relationships. Let me tell you how.

As long as the relationship is

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

going very strong, nothing matters. But after few years, cracks appear

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

for different reasons. Those who have the understanding about their p

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

artner’s mind can take care of that misunderstanding quickly. Others n

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

Professional from academic institutions, pharmaceutical industries, health care indust

ever get a hint that something is boiling. They realize only after a l

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

ot is lost.

Please find out more about each other when the going is g

.

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

ood. Play this game of I guess, you guess regularly. This will help yo

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

Companies that provide selfless information through particip

u more about understanding each other and will stop any crisis mid way

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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