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Six personal gifts, to control your own destiny and stay GREAT!

Greatness is being responsible, and doing what is expected of you

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

.

To be in control of your own destiny you must be pro- active. Life takes place in a decision. When you take action to make s

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

Examples of combination products may in

omething happen, stuff is going to happen. What to do about what happens, after you make something happen is where you take contro

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

l. When stuff happens that you did not plan on, that is opportunity knocking!

First personal gift: Authority: Without author

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

ty someone else is running the show. You are the authority in your life, nobody thinks in your mind. You are the center that watc

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

Combination pro

hes and runs the show that can choose which way it will go. The I am consciousness. Take charge of your own destiny. Guess what?

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

Now what?

Second personal gift: Commitment: Without commitment there is no long term persistence. Persistence creates desir

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

e and builds knowledge. Knowledge must build, because of so much opportunity. One must have a heart felt commitment in any endea

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

or they undertake. Be committed to yourself first, your family second, your profession third, your community fourth. Love is a fe

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

eling of commitment. Commitment is a joining of forces.

Third personal gift: Grace: You must have permission from yourself. W

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

ithout permission you will procrastinate. You will sit and wait. Those who hesitate are lost.

Fourth personal gift: Knowledge:

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

Following aspects would a

Without knowledge you will have no power to take action. Knowledge creates knowledge. Learned knowledge is power. Observe, listen

dd to the challenges in developing combination products:

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

read, smell, taste, touch, practice, practice, and practice. I am willing to listen, learn, and change how I think! Think BIG! I

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

t does not cost anything to think big. When you think big, you are taking care of yourself. When you think small you are focusing

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

on your ego. The self always thinks big!

Fifth personal gift: Opportunity: Realize that problems are only Opportunities based

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

on how you view them. If you can’t do any thing, pray for someone else. If you can’t pray, ask others to pray for you. If possib

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

Professional from academic institutions, pharmaceutical industries, health care indust

e, do something! Faith with out works is dead! Problems are sometimes opportunities for you to keep control of your own destiny

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

.

Sixth personal gift: Spirit: Sprit is so important because it brings energy, and excitement. Spirit must grow because the o

.

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

pportunities will grow as times go on. That’s the spirit! Copywriter 2004 marinojr@

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

Companies that provide selfless information through particip

bellsouth.net Please visit: www.mikemarinojrinperson.com

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

In the construction industry, the guidelines can be very strict. In today busy world, those who are in the market for a contractor do not want to take any chances of hiring someone that is not properly trained. A cost estimator is hired by a General Contractor and will create an estimate that contains all of the materials and labor that is needed for a job. The cost estimator must also take into consideration all heavy equipment needs, trash removal, weather and any other delay that may occur.

You can accomplish 20 times as much with the same time and resources, or the same results with 1/20 the time and resources. This article describes examples of how these effectiveness-improving results have been accomplished.

The basic requirements for contracting with non-english speaking consumers in California.

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Digg It - Six Personal Gifts-To Control Your Own Destiny And Stay Great!

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