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It was one of those long, hot, muggy, sticky, (did I say hot?) July days in New Brunswick: You know the kind: It was the kind of day where even staying still was too hot of a thing to be doing. Any effort that was made to move or to create a breeze to cool your skin

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

was just way too much effort, and brought out rivers of sweat. The only good thing was that on the horizon were black rain clouds that held a promise of rain that could fall at any minute.

I was only 15 at the time, and we were in CFB Gagetown, Camp Argonaut for Army

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

Examples of combination products may in

Cadet Camp and we were practicing for our final parade which was to be the next day, and we were getting worse, instead of better. Any normal person would have been sitting with a nice cool glass of water in a cool, comfortable refrigerator, but not us, nooo that wou

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

d have been way too easy. We were standing out in the blazing sun, army uniforms on, doing drill. It was so hot, even the polish on my boots was melting. It must have been the heat affecting us, but the drill that we were doing was just awful. The funny thing was, t

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

he few days before that we practiced it, we were flawless, but now that the heat was on, we were as bad as or worse than we ever were. Actually, it was kind of funny to see as some people were turning right on a left turn command, some were halting when we were suppos

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

Combination pro

ed to be marking time, there were even some who seemed to have forgotten how to swing their arms in unison with their legs. Even though we were hot and tired and frustrated, there was still a lot of laughing and giggling at the dumb mistakes, which seemed to make matt

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

rs worse with the drill instructors, as well as the ones in the troop who just wanted to get it done and get out of the sun. Tempers were starting to flare even hotter than the July sun.

“Boys, we can do this all day if you want to, but until I start to see some pride

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

and perfection, I don’t care if it’s two hundred degrees, we’re going to stay here until it’s done right. Do you understand me?” The drill sergeant barked. “Yes Sergeant” we said in unison. “Then let’s get this done!” he said again.

He had no sooner said that, whe

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

n the storm clouds just opened up and drenched us with its full load of rain. There was nowhere that we could go for cover, so we just kept on doing drill in the wind and the rain. It rained, and rained and rained. I thought for sure that it would never stop, but af

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

er about 15 minutes of steady, heavy wind and rain, it stopped as fast as it started and the sun shone again. As miraculous as it was to see the sun shine again, our troop, after the rain, miraculously became the same well oiled, practiced precision drill team that we

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

had been a day or so before. We practiced for a little bit more and the sergeant wheeled us off the parade square and pointed us towards home. Then in a scene reminiscent of the movie “Bridge over the River Kwai”, someone started whistling in step to our marching an

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

Following aspects would a

d before long everyone was whistling the same tune. We had become a team again: It just took a storm to bring it out of us.

I watched an interview with Bono, from the Irish band U2 recently, and one of his quotes really captured my imagination, he said “There is noth

dd to the challenges in developing combination products:

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

ng like a storm of life to bring out the truth of our possibilities” To me, that was one of those gems that really spoke to me, heart and soul, because it really IS in the storms of life where our qualities are sharpened. Just as steel needs heat to become tempered an

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

d fine china needs a few firings of over a thousand degrees before it becomes ready to be used, so too do we need to be formed in periods of heat and pressure to create and purify our abilities. Without the benefit of heat or pressure, or by running for cover, we cann

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

ot become competent. We must learn to live in our tension, as this is where strength is formed, and mountains are moved.

Do you wish you could be stronger or braver and achieve the goals that somehow seem to always evade you? Are you willing to make a change (in you

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

to make a change (in your world)? Yes? Are you willing to stand in the rain of a storm of life to purify your abilities? I imagine that you are.

The first thing that is needed then is to determine what it is that you would be, and seek out the “storms” that could cr

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

Professional from academic institutions, pharmaceutical industries, health care indust

eate that ability in you. Yes, I said “seek out the storms”. Don’t run from them, run towards them. Stand naked, without barriers under the rain cloud and feel the fullness of the message. Absorb the winds, bend with them, but don’t let them break you. Then, when th

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

e winds of change have stopped, spring back to life and put into action what you have learned. The next thing is to convince yourself that you are not afraid of any storm, no matter what it is, because you are not alone; you have your faith to keep you grounded, and yo

.

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

have your team to keep you moving …bring it on!

This week, as you are being battered by the storms and squalls of your life, take the time to look deep within yourself and realize that you are a person of action: you will not be afraid. Though you may get some scrap

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

Companies that provide selfless information through particip

es and scars, you will weather the tempest and proceed into life with the confidence that no matter what the storm, no matter what the setback, you will know that right in the middle of a storm is a good place to be.

To all of the success that you can handle!
Pau

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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Well it looks as if we need to make some serious choices with our government, as they just will not stop spending will they? They just keep blowing money on all sorts of crap, none of really relevant to anything in the Constitution, except the military expenditures perhaps

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Many people these days are using some sort of raid array on their computer system. This is done for several reasons and the type of raid depends on what you want it to do for you. Here I will briefly explain the two most commonly used configurations.

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