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I am an idiot. All she wanted was for me to get my act together and I was too stupid to understand what that meant. That meant, I love you. I have chosen you as my mate. I am willing to spend the rest of my life with you. Bare your children, raise a family, watch it grow. I will

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

be yours forever, if you just show me what I need to see. Show me that you will take care of me. Show me that you can play your role as a man and I will play my role as your woman as long as we both shall live. I did not play my role.

This is not the first time I have done thi

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

Examples of combination products may in

s. There was another before this and she told me the same thing. I felt sorry for myself then and watched as she married another.

I have this dream that I have been chasing for some time. Because of this dream and needing to chase it just so, I have watched two women that I lov

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

e walk away from me shaking their heads. They both told me they would leave. They all but pleaded with me to change my ways. I convinced myself that they were trying to change me. I believed that if I did not do it my way, while I had nothing, it would not be as genuine. I thoug

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

ht I needed to struggle to be happy and gain everything out of the experience. I did nothing. I wrote several items, but did nothing with them. I was waiting for some magical person to read everything and discover me. I was this amazing writer, someone had to see that. I could t

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

Combination pro

ake them on this ride with me, if they could just wait until I figured out how this dream would come true. My patience level has been for too strong.

I told both these girls that I knew I could win the lottery if they just waited for someone to hand me the winning ticket. I hav

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

e taken no initiative, shown no ambition to even go buy a losing ticket. I have just expected them to believe in me and "someday" I would take care of them. What have I done to make them believe that? I doubt that either questioned my love. I know they could see in my eyes how

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

much I loved them. They needed me to show them the one other part they were looking for. I did not play my role.

I had nothing to offer other than love. I am articulate, presentable, intelligent in other areas and everyone knows that I have the ability and tools to be anything

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

I want to be. But at this point, that's it. I have done nothing to prove it. I have a great family that has supported me through a lot of bad dreams. I have done everything to push them away and all they do is attract more people to me. But she already had all of that. She has h

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

er good family. She has her intelligence and presentability. She is using her tools to be the person that will attract the type of person I could be.

It goes back to when boys are boys and girls are girls. Our lives start out with these responsibilities. A mother shows her son

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

the way a woman should be treated and take care of her family. He watches her do this and he begins to develop the structure that will represent what he wants someday. Girls are the same way. Their fathers are their heroes and when they go look for a man, they look for that feel

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

Following aspects would a

ing. They want a hero who is going to take care of them and relieve their crazy minds. In return they will love you and keep you from becoming that crazy. It's a trade off and there is only so long that they can feel comfortable with how much you love them. You have a role to pl

dd to the challenges in developing combination products:

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

ay. I had a role to play. I did not play my role.

I have every ability to do any task I put my mind to. I fell in love with a girl who loved me. She convinced me of it. Proved it to me time and time again. I took that love and repaid it with nothing.

The end was the worst part

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

. I took her trust, her personal dignity, her precious moments with me and I threw them in her face. I threatened to humiliate her in a way that is unforgivable. All because I saw that she had taken all that she could take. She was at the end of her rope and I had nothing else t

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

o fight with. So I went to a place I knew I could never return. Some things can be forgiven, but they can never be forgotten. I know that if we ever found a way to reconcile, it would forever be a shadow in the background. I have never been more regretful of anything I have done

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

to someone I love. It remained a threat and nothing was taken further. But by mentioning it, by thinking it, I had crossed a line I never thought I would see. I killed her love because I could not watch her walk away. I am an idiot.

I know what I have to do now. Both women are

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

Professional from academic institutions, pharmaceutical industries, health care indust

tremendous in their own ways. I love them both for their similarities as well as their differences. They both made me feel like the sun was shining on me heavier than any other person I have met. So the template is set. I can not imagine having so much as a friendship with a gi

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

rl right now. But that will end eventually and I will know what I want. There is a lot I need to do in the meantime. Until I find the pot of gold at the end of this rainbow, it is only a rainbow and they disappear with the rain. The next time I am feeling like this it will be fo

.

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

r different reasons and several years down the road.

So guys and I know I am not the only one who has been here, it's time to step up to the plate. I know I am ready. I have spent too much time telling everyone how well I can hit the ball. It is time to step up to the plate. I

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

Companies that provide selfless information through particip

may not hit the ball out of the park on the first pitch, but I will get on base. I will hit the ball and I will play the game. I have spent all this time asking myself why this is happening to me. I should have been thanking them for showing me. I am an idiot and I'm sick of it.

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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