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What is it? Where does it come from? Well I will tell you --- it is that realization in that spot of your head that lights up

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

like a banner - that calm all knowing feeling - that voice inside all of us.

Hello and welcome to my space and passion of p

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

Examples of combination products may in

ychic power. Have you ever watched Deal or No Deal, where there a 26 boxes and the contestant chooses one. Then as the show p

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

rogresses the contestant picks a box with the idea of not knocking out the big money. As the show gets going how many times 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

ve YOU actually picked the dollar amount in the box before it was opened? Does not work every time but I bet a lot of you say

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

Combination pro

they have actually made the right guess.

GUESS or maybe it was psychic power working. When the telephone rings do you say to

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

yourself I bet that is... so and so and low and behold it is THAT person.Yes we all have psychic power but do not know how t

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

use it. What is it? Where does it come from? Well I will tell you - it is that realization in that spot of your head that li

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

hts up like a banner - that calm all knowing feeling - that voice inside all of us. My wife has friends who are a solid based

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

family. The Father was recently diagnosed with Pancreatic Cancer. The doctors had to operate.

The Father came around to my

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

ouse with his wife on the Sunday before he went to Hospital. He was convinced that he would not be coming home. The Father wa

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

Following aspects would a

upset, his wife was upset and my wife was upset. What about me though, I could not care less and I felt no pain or sadness.

dd to the challenges in developing combination products:

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

Am I a selfish cold hearted shallow person that would not care to think of another's pain? No I am not like that because I fe

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

t this calm all knowing thought that everything was going to be all right. I knew the Father was going to be fine and in fact

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

I said, "Don-t worry, we will see you again and all will be well". The Father went to hospital for surgery and subsequent tre

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

atment. Did not look to well when he came back and I did not see him for two months. Sitting on the couch the other day somet

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing happened that proved I have to say something.

My wife said he was cleared by the doctors, they got all the cancer and he

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

is fine. How did I know that? I am never right but this time I was! THIS is psychic power and we all have it inside but do no

.

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

t listen to it nor do we recognize it. To develop our psychic abilities we need to look inside and listen to what we are bein

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

Companies that provide selfless information through particip

told. Thanks for reading this. I had to say something and now I have done it. I am sure there are many experiences like mine

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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Just what does it take for a Mom to succeed in a small business? Find out from a successful work at home Mom with 4 years experience.

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