E-Articles - Health and Fitness

As a person who drank fairly heavily for the better part of 15 years, I know this is a question that I u

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

sed to ask myself almost daily. I would quickly reiterate to myself that it was no problem and continue

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

Examples of combination products may in

my life as normal. But in the back of my mind, I always figured that I probably did. What constitutes

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

drinking too much? Who knows? That's for people to decide for themselves. On the average I drank abo

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

ut a 12-pack of beer a day, so you can think whatever you would like about that.

Then one day something

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

Combination pro

strange happened. One day I woke up, was divorced and had a 1-year-old daughter. It seemed to me that

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

this all happened out of the blue. It of course didn't, but it still seemed as if it did. Then one da

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

y my ex wife called me and asked if I could take our daughter full time. I of course said absolutely, a

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

nd then started to think.

I decided that if I was going to be raising my daughter, I didn't want her to

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

be around alcohol. For some reason, in my mind, this fact changed everything. I simply didn't want to

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

be a bad example to the person I cared about the most. So after fifteen years of drinking everyday, I

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

Following aspects would a

walked away from it and haven’t looked back. Actually, in getting sober, I've realized so many truths t

dd to the challenges in developing combination products:

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

hat I'd obviously been denying, and the biggest of those truths was that I drank entirely too much. Now

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

I have no interest in having even one drop of alcohol.

Was I an alcoholic? Who knows, but now that I'

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

m sober and the alcohol haze is gone, I know that I wasted most of those 15 years because of my altered

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

state. That's literally the realization that came to me. For most of those 15 years I was in an altere

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

Professional from academic institutions, pharmaceutical industries, health care indust

d state. What's amazing to me is that no one told me! That's probably because they were in the same st

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

ate.

So, is your drinking a problem? That's surely not for me to answer, but if you think it could be

.

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

it probably is. As Melville said, "Just go inside and ask what your heart doth know." The answer that

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

Companies that provide selfless information through particip

you're looking for is within yourself, I promise you. That or just have a daughter…that sure helped me.

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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