E-Articles - Health and Fitness

Last Tuesday I hurt myself again, badly. I push myself beyond the limits that pain receptors fire within my brain, past yellow warning lights, ripping through red lights, finally smashing throu

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

gh the "Bridge Out" road block, in hope to give myself a hearty, healthy cardio-vascular workout. I measure my performance on a personal "speedometer": my heart rate. If after 9 minutes on a r

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

Examples of combination products may in

eclining stationary bike I'm above 140 beats a minute, I gun the last minute in hope that I'll set a new personal best record, perhaps burning 125 calories over the previous ten minutes. HOORAH

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

! It hurts like hell. Know that, but so what, I'll have set a new personal best; I shatter old records but at a high cost: 3 days in bed.

This truly idiotic destruction of my previous records

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

doesn't accelerate my recovery. Just the opposite, it sets me back. It slows my recovery, robs me of sleep delivering a bill payable in pain. It slows my walking. It causes me to lean heavil

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

Combination pro

y upon my cane (and breakthrough narcotics) so that I mumble, tumble, wobble, drool, and fall over. Side effects from the narcotics dampen my memory. New pain arrives in the form of back spasm

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

s, leg cramps, pinched nerves in my neck and constipation of my bowels. Driving a car, even short walks are impossible in the recovery period. The pain doc repeatedly warns me against this beh

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

vior, but I ignore him. I've tried to explain that this is not something I do, it's who I am.

A Gordian knot of trouble. I'm not a masochist. I hate pain. So, why do it?

My shrink set me s

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

traight on this point. I was right, this is who I am. The key, the solution is for me to accept one simple fact, to unwind the knot with which I've lived my entire life...

I HATE PAIN BUT WILL

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

ENDURE IT AT ALL LEVELS UNTIL MY BODY REFUSES TO GO ON. I REACH POINTS OF COLLAPSE, ALMOST LIKE SHOCK, WHEN MY BODILY SYSTEMS SHUT DOWN. BUT I GO THIS FAR IF THERE IS A REWARD FOR ME: A NEW P

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

RSONAL "BEST" THAT I WEAR AS IF IT WERE A MEDAL AWARDED FOR HEROISM.

I will pay a price for a reward. I will, and have, pushed through to physical breakdown if the prize is something I value e

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

Following aspects would a

nough. I am the rat in a Skinner Box.

The Pain Scale doesn't work for me. I mentioned this in an early post where I described a conversation with my pain doctor when I asked him to explain if

dd to the challenges in developing combination products:

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

"10" was dead, or just shocked or knocked into unconsciousness. He said "10" is the worst pain you've ever felt. I told him I wasn't awake for that. The conversation was like a chat between

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

2 people on mobile phones when both parties are between cells.

My Psychotherapist explained, citing incident after personal incident from my life, that I don't experience pain as many other peo

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

le do. I often experience pain as simply the cost to reach a goal. If I didn't see a prize, we'd probably view pain similarly. Thus the management of my pain today, pain without a prize has

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

only 2 conditions: I have pain, or I don't have pain.

If you've read this far, here's the pay-off for this 2 part article. My specific crisis now is not just enduring a high level of chronic p

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

Professional from academic institutions, pharmaceutical industries, health care indust

ain. My crisis is different. It is "Loss of Function" My lodestone is that I will, unfortunately, willingly endure all manner of pain to the point of bodily collapse if I believe that I can

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

egain function. A dangerous game, one worth playing. One that I could lose.

My shrink strongly urges me, at this point, to change "games". He suggests one that offers a real prize instead of

.

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

an illusory melodrama; functionality, but that which doesn't expose me to the brinkmanship of a high risk physical game. I've used the word game in a formal sense in this article as it might r

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

Companies that provide selfless information through particip

elate to game theory, particularly tournament game theory in which one loss eliminates a participant from the game. Perhaps, recovery without self-absorbed faux heroics. God bless us all, Coli

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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