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I find it perplexing how a person's thinking can become……..well clouded. I quit drinking quite a while a

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 and it seems to me that things become clearer almost by the day. I was having a discussion with a fri

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

Examples of combination products may in

nd about my drinking, back when I drank. People used to say, "come on over and have a beer" all of the t

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

ime. And, of course, I would oblige them. The funny thing was it was never, and I mean never A beer. I

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

always ended up being at least three beers and most times many more than that.

Was I an alcoholic? I d

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

Combination pro

n't know, but I do know I drank a lot. In my estimation, it became too much, so I stopped. It took me t

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

he better part of fifteen years to come to this conclusion, but I finally came to the realization that I

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

as drinking too much. The bottom line was that I drank quite a lot of beer. I more or less stayed away

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

from the hard stuff, mostly because I liked the way beer 'tasted', or at least that's what I told myself.

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

Then recently I found myself with an old friend, reminiscing about the days when I used to drink with hi

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

, and something came to me. I said to him how I find it funny that for the most part I drank a 12-pack o

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

Following aspects would a

n most nights. Some nights more and some less, but the average had to be about twelve. Then I said to h

dd to the challenges in developing combination products:

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

m, "Bob, I bought a twelve pack of Coke the other day and I can't even imagine sitting down and drinking

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

it all in one sitting! It amazes me that I used to do that exact thing with beer." After that conversat

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

on I realized that at the time in my life when I did slam a 12-pack in one sitting, I wasn't thinking cle

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

rly at all. Not even close.

Just like it being perplexing about how clouded your thinking can become, i

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

Professional from academic institutions, pharmaceutical industries, health care indust

t's equally perplexing how clear your thinking can become when you sober up. I'm not at all a religious

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

erson, but have to assume there was a higher power involved in this process. All of these thoughts and r

.

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

ealizations just fit together too perfectly for any other explanation that I'm aware of. All I know is t

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

Companies that provide selfless information through particip

at there was a time when going out and "having a beer" actually meant going out and having at least three

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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There are many pitfalls of raising funds with product sales, even for the well-prepared, and selling goods can be a downright minefield for some organizations.

Children ages 1 to 3 are getting fatter and fatter, according to a recent University study. Proper diet solutions are very simple, according to the Mayo Clinic. They incorporate a common sense solution to food selection while grocery shopping, and giving up sugary drinks, pasta and baked goods.

Check out 4 types of overeaters and the solutions for managing it. See if you recognize yourself! What Type of Overeater Are You?

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