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In our last article, high achievers were simply defined as having a predisposition towards perpetual action. To begin and see through what they reso

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

lved to do, no matter what.

This leads one to ponder the reasons why so few act. What separates the doers from the rest of the pack? Extensive res

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

Examples of combination products may in

earch points to the reasons why winners keep winning.

Winners think optimistically, no matter what!

There is this law, the First Law of Thermodynam

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

ics that we must understand. Put simply, the law states that everything in our Universe tends towards chaos.

Businesses will fail, investments will

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

make losses, relationships from time-to-time will prove challenging. I read somewhere recently that the average self-made millionaire goes close to o

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

Combination pro

r becomes bankrupt on average, 3.2 times. Isn’t that amazing?

Optimism allows us to move on, despite our setbacks, despite our bruises. There are n

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

o failures if we learn and decide to bounce back from such obstacles. Failures are only failures if we decide to remain defeated..

The word “optimis

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

m” gives us some more clues here. ‘Opt’ equates to choice. Each one of us has a choice, to see things pessimistically (glass half empty) or optimis

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

ically (half full).

In 480 BC, a brave band of 300 Spartans decided to defend democracy at the pass of Thermopylae against a force of 200,000 Persi

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

ans. The Persian general, Hidarnes warned his Spartan counterpart Leonidas, that his army’s arrows would be so thick that they would block out the s

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

unlight. Leonidas welcomed the dilemma, answering that his men would happily fight in the shade! The Spartans held the pass long enough to later thw

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

Following aspects would a

art the Persian advance at Platea. Optimism.

Winners are winners because they have embraced failure. It’s not what happens to them that determines t

dd to the challenges in developing combination products:

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

eir rewards. It’s how they perceive events.

Martin Seligman, in his latest offering. “Learned Optimism” states that champions view negative events

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

as being one off incidents, whereas losers think of them as being permanent and pervasive, here to stay. Losers allow setbacks to affect them long t

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

erm, thus nullifying future attempts to move forward.

So what if you have made mistakes in the past. Hey, welcome to the species …Homo sapiens. W

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

e all fall on the side of error. Embrace life’s challenges and its associated setbacks. How else do you think you will grow? How else would you le

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

Professional from academic institutions, pharmaceutical industries, health care indust

rn? Be grateful.

Key Questions:

The most important conversation you will ever have is that with YOURSELF. What are you saying to yourself? Ninety-

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

five percent of what happens to you depends on it.

Even more importantly, what are you exposing your mind to? The incoming noises from people, medi

.

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

a, the environment – what messages are they delivering? Are they negative or positive?

Get out off negative situations, negative people, and the ne

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

Companies that provide selfless information through particip

gative news. Start feeding your mind with positive nutrients. Good books, programs, events, most importantly people. Eagles don't fly with turkeys

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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On a Saturday morning early, I was watching four of my articles coming up on the home page at Ezine Articles. I thought it was a good time to do some reading from the home page. Here is where a title stands or falls. I was about to learn a lesson of intuition.

The Democrats must not only address the issue of War in the Middle East and terrorism, but energy, immigration and the environment. The Democrats best suited for this are former Vice-President Al Gore and New Mexico Governor Bill Richardson. This would be the Democrats' strongest ticket and give them their best chance for victory in 2008

Today’s statistic shows that about 55% of Americans are overweight or observe. It seems that unhealthy fast food reached its aim – most of people like it and don’t think how these meals affect their weight. Also, many of them make a big mistake thinking that diet pill will burn all fast food calories… Later it comes time to lose overweight, but many of us may be falling prey to some common diet myths. Let’s outwit them.

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