Main Subject - Business

Twenty or more years ago I took several evening courses in an effort to meet other people and especially women.

One of the courses I took for about a year was Tai Chi. The major benefit of the course was to learn about balance. The instructo

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

r demonstrated to us how most of us walk. We take a step, then fall forward and catch ourselves with the other foot before the rest of the body hits the ground. In other words we stumble forward. When we are in balance we can move forward wit

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

Examples of combination products may in

h deliberate steps, and we should be able to stop anytime in the middle our stride without falling forward.

Stumbling is what most people do in their lives. We try to gain some momentum in our lives and hope we don't fall flat on our faces.

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

We rely on our past experiences to guide us to the next step.

As infants we were cautious about each step and we thought about it before we took the next one. After a period of time we learned that if we shifted our weight forward it would c

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

ause the body to move in the same direction we wanted to go-sometimes a little faster than we want and we would fall. As we moved away from managing our steps, we found walking easier if we didn't think about the steps and focused on were we

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

Combination pro

wanted to go. We looked up at Mom or Dad and fell towards them or the sofa-running to keep up with the rest of our body.

The knowledge we have gained as infants we use over and over again as we struggle to be both independent and socially ac

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

cepted. The stumbling sometimes works and sometimes does not.

Because most of us were not taught to be critical thinkers and have little access to the experience of other as children, we mimic them and most times fall flat on our faces. The

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

steps of independence we were taught was usually in the footprints of someone else. We trusted those who had power over us to lead us in the right direction.

Humanity, individually and together has never really got together and decided what

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

it wants to experience collectively in the future. We have been tripping through life hoping the forward motion will take us some place better-living for today, lunging forward one step at a time. Humanity for all its technology is no better

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

off now than it was when it crawled from the sea. Many would argue against that statement-they would point out our advancements in science, health, art and general well being. However, it is observable many have not come very far in their que

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

st for happiness, abundance, and equality. There is no game plan and no enlightened direction. The world simply does not know what it wants consciously.

Religion, faith and leadership have not brought us to where we want to be, and it never

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

Following aspects would a

will. Maintaining balance in one's life is a personal experience. Moving in a personal meaningful direction is choice. The world is perfect the way it is, it is the way we made it. We are the creators of what it is we now experience.

I belie

dd to the challenges in developing combination products:

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

ve we know where it is we want to go subconsciously and what we want to experience, but we have been listening to and guided by sources who do not want us to get there. People and organizations with their own agenda.

Following the leader tak

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

es us to where the leader wants us, and we don't have to take responsibility for our actions-we just keep stumbling forward.

We have the power to take ourselves to where we want to be. No one can ever do that for us. We have become lazy and

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

apathetic about our own lives. We struggle to just get through the day and hope everything works out, and we are still not at the place we desire. We have been doing the same thing for centuries-same actions-same response, same results, and i

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

t's not what we want. This must be the definitive description of insanity.

We have traded our natural curiosity and adventurous nature for obligation and fear. We have given our power away for a meager measure of security. It's not that we a

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

Professional from academic institutions, pharmaceutical industries, health care indust

re powerless to change our circumstances; it's that we believe we are. Groping through piles of misinformation about whom and what we are has left us numb as to our true identity. Our source of inspiration and guidance has let us down. While

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

we have fallen face down into piles of the stuff, our sources of spiritual guidance are still ringing out the same rhetoric.

I have the power-you have it, as does everyone else-it's all in the head, in your imagination. You are creating all

.

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

the steps in your life. There are no promises that can help you-no faith can turn it around until you decide that you are going to walk for change. Neither faith nor God moves mountains-you do!

Take a new trip, one you create from a sincere

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

Companies that provide selfless information through particip

desire to live in a different world. The steps may not be easy, but the results are as simple as knowing you can make them.

Move your life forward, not by stumbling, but by balance in your steps, intention, and a strong desire to get there.

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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If you live or own a business in the Dallas area, there is a good chance that you have access to a Dallas phone book. You can use you Dallas phone book to find a number of Dallas carpet cleaning companies in or around the area. In the back of your phone book there is a section that is referred to as the yellow pages or the business directory.

Preparing an identity statement to ensure that your potential clients know just who you are and what you do and why they should care. Your identity statement should be memorable, have purpose, identify your qualities, explain who it is you serve and answer the question – Who Cares? When you have all of these factors, your potential client will be intrigued enough to ask more questions.

There are many clones of the Million Dollar Home Page, but they lack innovation and will very likely fail. In this article I discuss some ways to innovate.

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