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Have you ever been just plane tired of your everyday life? Work, work

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

, work!!! Just to make ends meet and then what do you know, they don’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

This is my idea of a good day, and I can’t even call it work. I get

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

up and look at my computer to see if I have made money. Yes I have,

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

hat is nice now I will set aside an hour or two to make more. I love

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

Combination pro

games, computers and books and this business gives me the freedom to d

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

what I like anytime I want. That is a big plus for me, as I am going

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

to school to learn more about what I sell, mostly about computers bec

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

use that is just fun for me. If life isn’t fun and your work doesn’t

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

make you happy what have you accomplished?

I can’t say it was always

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

asy because it was lots of hard work and lots of time out of my life t

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

Following aspects would a

o start with. I had some times when I didn’t think I could make a go

dd to the challenges in developing combination products:

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

f this, and some times when I just plain wanted to quit but that was o

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

nly when I felt sorry for myself because I wasn’t doing what I like to

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

do. I kept going and kept saying to myself that it would get better 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

n the end and it has. When I look back on what I had and what I have

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

Professional from academic institutions, pharmaceutical industries, health care indust

ow, I can’t believe that I am the same person. People look at me now

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

and say how can he afford that, and I just smile and say “You can do w

.

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

at I do, let me show you how.”

If it weren’t for my on line business

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

Companies that provide selfless information through particip

I would still be tired and broke. Let me show you how to do what I do

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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