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There are many entrepreneurs out there who are quite good at wh

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

at they do, but often my hat goes off to the solo practitioner

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

Examples of combination products may in

ho is making it all come together. Why you ask? Well simple rea

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

ly; being a Solo Practitioner at anything well that is not easy

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

Why do people go solo? For lots of reasons, as maybe they are

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

Combination pro

o good at something that they are in the top 1-2% and they 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

it and they simply cannot see themselves fixing others mistakes

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

all day, as it will never be as good as if they did it them se

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

ves.

What most business people who are consultant types find v

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

ry quickly is that good help is hard to find and only hangs aro

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

nd for a short period 2-3 years, while you teach them everythin

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

Following aspects would a

you know and then when they finally get it they move on as the

dd to the challenges in developing combination products:

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

average person in the United States for instance changes jobs e

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

ery 3-4 years anyway?

Needless to say being a solo practitione

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

r is hard work, but they also save the head aches by doing more

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

of the work them selves. One thing I always noticed when hiring

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

Professional from academic institutions, pharmaceutical industries, health care indust

consultants was that if their wife answered the phone as their

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

ecretary or husband in many cases, that I generally had on my 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

nds the best person for the job because they were solo practiti

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

Companies that provide selfless information through particip

ners and they were good at what they did. Consider this in 2006

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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