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Why do we have them? Because we want you as a customer. Why do you

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

go to them? Because you want to look at houses without committing t

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

Examples of combination products may in

o one agent.

This is just my personal observation.

If you go to o

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

en houses you may recognise the following conversation.

Realtor: H

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

i I'm Joe Realtor Lookiloo: Uh.. Bob (reluctantly shakes hands) Rea

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

Combination pro

tor: So you live in the area? lookiloo: Yeah Realtor: Thinking of m

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

oving? lookiloo: uh...dono maybe Realtor: (with suave smile)well ma

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

be I can help. lookiloo: ........... Realtor: How about if I just c

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

all you when I see something you might like? lookiloo: well...uh...

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

I'm really just ah....

Solution

Remember we view you as a potent

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

ial client, and we have bills to pay. Just like a nine to five job

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

Following aspects would a

we hope to get back what we put in. That doesn't mean we expect to

dd to the challenges in developing combination products:

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

et a deal every time someone walks through the door, but the more y

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

ou ask of us the more we expect or at least hope for compensation.

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

When the Realtor introduces him/herself just say hi I'm so and so I

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

already have an agent but I think I may be interested in this hous

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

Professional from academic institutions, pharmaceutical industries, health care indust

is it alright if I look around? Its really tough to say no to some

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

one who is friendly and polite, besides maybe you'll buy the house.

.

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

Its simple. Skip the sales pitch and look at the house. Who knows

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

Companies that provide selfless information through particip

if you like the agent you may choose to do business with them later

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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Properly considering the future, as far out as it may seem to be, can reduce stress and financial strain. These scenarios cover what you need to keep in mind.

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