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What are the sharpest tools in your toolkit? Is it your business website or brochure? How about your press kits or pitch letter? Often solo entrepreneurs first think of a technolo

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

gical tool since technology allows us to "do more with less cost". The truth is your sharpest tool is your mind which is where every action is first created. Consider the following ways

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

Examples of combination products may in

to sharpen your best tool.

A Fish Tale

A favorite fish of many hobbyists is the Japanese carp, commonly known as the koi. The fascinating thing about the koi is that i

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

you keep it in a small fish bowl, it will only grow to be 2 or 3 inches long. Put the koi in a larger tank and it will reach 6 to 10 inches. Put it in a large pond and it may get as lo

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

g as a foot and a half. However, when placed in a huge lake where it can spread out, it has the potential to reach sizes up to 3 feet. The point is pretty clear. The size of this fish i

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

Combination pro

s directly proportional to the size of the pond. A comparable analogy can be made concerning people. Our growth is determined by the size of our world. Not the physical dimensions, but

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

he mental, emotional, spiritual and physical opportunities we experience. Realizing that our growth comes from the inside, we better understand that that unless we expand who we are, we

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

ll always have what we've got. Think of it this way, SUCCESS BEGINS WITHIN.

HEADLINE New York Times, 1991 "Optimism Emerges as Best Predictor to Success in Life"

Daniel

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

Goleman, author of Emotional Intelligence, reported on this groundbreaking research conducted at the University of Kansas. What was discovered was this: People with high levels of hope

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

share several attributes:

-- They turn to friends for advice on how to achieve their goals.

-- They tell themselves they can succeed at what they need to do.

-- They be

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

ieve that things will get better as time goes on.

-- They are flexible enough to find different ways to get to their goals.

-- If hope for one goal fades, they aim fo

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

Following aspects would a

another. Those low in hope tend to become fixated on one goal and persist even when they find themselves blocked.

-- They show an ability to break a formidable task into specif

dd to the challenges in developing combination products:

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

c, achievable chunks.

People who get a high score on the hope scale have had as many hard times as those with low scores, but have learned to think about it in a hopeful way, seein

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

g a setback as a challenge, not a permanent failure.

This study proved what wise people knew all along - YOUR ATTITUDE AFFECTS YOUR ALTITUDE.

It's All About Attitude

Yo

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

hear that all the time, but what does it really mean?

-- Expecting the best in everything--not the worst.

-- Remaining upbeat--even if you get beat up.

-- Seeing so

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

utions in every problem--not problems in every solution.

-- Believing in yourself--even if others believe you have failed.

-- Holding on to hope--even if others say

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

Professional from academic institutions, pharmaceutical industries, health care indust

t is hopeless.

Here's the good news: Positive attitudes can be learned. One of the fastest ways to transform our attitudes is with our language. These are the words you want to

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

eliminate from your vocabulary: I can't. I don't have the time. I'm afraid of. I doubt it . These are the words you want use more of every day: I can..I will make the time..I am

.

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

confident. I expect the best. YOUR WORDS SHAPE YOUR ATTITUDE.

SUCCESS BEGINS WITHIN. What are you willing to do differently as you create your next success? Close the ga

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

Companies that provide selfless information through particip

between KNOWING and DOING by taking a single action each day. Challenge yourself to raise the bar and enjoy the possibilities! TAKE ACTION NOW!

Copyright 2004, Charlotte Farrio

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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So, it seems pretty safe to say that if you are familiar with the general questions one can be asked, you can answer them very confidently AND ease the pressure you may experience. Do you recall your high school or college speech class? Many of the techniques utilized during a speech can also be helpful during your interview. It may feel like an oral examination, but there will always be one aspect in your favor: nine times out of ten, there are no wrong answers! As far as the person conducting the interview is concerned, the questions are available for them to learn about you. Therefore, who better to have the correct answers concerning yourself then, well - yourself!

IT consultant time management is crucial when beginning your practice. Spend your time working on leads, prospects, and sales to become a full-time IT consultant.

Do you monitor the results of your strategic plan? Is that monitoring constant and consistent? The failure to monitor the progress of the plan dooms many plans within the first few weeks.

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