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Steve Irwin: that name even two months after his death causes my eyes to well up in tears. I still just can’t qui

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

te believe he’s dead. I can’t absorb the reality of it. I can remember grieving over public figures before, most no

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

Examples of combination products may in

tably the Challenger astronauts in 1986 and again for the most recent crew. Diana, whose selfless work for the unde

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

r privileged inspired everyone who had a heart. But this, by far, has hit me hardest along with millions of others.

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

I do love people, but I have a passion for animals, wildlife yes and mostly abused domestic animals. They’re so in

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

Combination pro

nocent and can’t speak for themselves. Steve and his Australia Zoo staff, most especially his “best mate” Wes spoke

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

up with zeal and educated us at the same time.

Maybe Steve couldn’t be compared to the likes of Mother Theresa, bu

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

t Steve Irwin was an enthusiastic environmentalist and unapologetically worked for the cause of conservation, a very

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

worthwhile cause when you think how the loss of a species causes problems with the rest of the balance of nature.

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

Many people, as much as they’d like, would love to traipse around the world having a favorable impact on the conserv

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

ation of wildlife, but we have a hard enough time just getting through our 9 to 5 jobs. Steve did for us what we’d

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

Following aspects would a

like to do for ourselves. And he did it so lovingly. Every animal was “a little beauty.”

The first five times or

dd to the challenges in developing combination products:

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

so when I first saw Steve in one of his commercials, I thought or even said out loud “HE’S CRAZY, THE MAN IS CRAZY.”

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

I thought he was a thrill seeker; someone getting a rush out of putting his life in danger. But then I realized,

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

after watching his show, that he knew what he was doing and therefore was not foolishly jeopardizing his life. I als

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

o believe that despite the rumors he was not unnecessarily rough with his animal friends nor did he tease them. Ste

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve had such a tender heart toward his family, friends and wildlife and wouldn’t hurt a flea. Watching his show, I n

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

ever got the feeling he ill-treated or exploited the animals. In fact, time after time I saw what a sort of sixth se

.

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

nse he had with the mamals. Animals that would normally rip your head off, he had an instant rapport with. However

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

Companies that provide selfless information through particip

, he never quite developed a bond with his beloved crocodiles. He often said “They want to kill me, but I love ‘um!

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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