Summary - Relationships

"The best way out is always through."

-Robert Frost

We all know that breaking up is hard to do. For years songs have

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

been written on how to get over heartache:

*50 Ways To Leave Your Lover...Paul Simon
*After The Love Has Gone...Earth,

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

Examples of combination products may in

ind & Fire
*Don't Go Breaking My Heart...Elton John and Kiki Dee
*It's Too Late...Carole King
*You Give Love a

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

Bad Name...Bon Jovi
*I Will Survive...Gloria Gaynor

And the list goes on and on and on. Did you ever wonder why so ma

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

y people can relate to these songs? Because most people have lived through it themselves; and by the way, they've survived

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

Combination pro

t too.

Although you may feel alone and lonely right now; just hang in there. And just like everyone else; you too will sur

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

vive your broken heart.

You may ask, "But what do I do in the meantime while I'm hurting?" Well, first you have to realize

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

that you can't go around it, over it or under it. You have to go through it. Getting over heart break is a process that you

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

can and will get beyond. You just have to allow yourself a little time.

Don't expect to pick up the pieces in a day or two

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

; it just doesn't work that way.

Be realistic about healing. The first couple of weeks or months will be the hardest, but

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

s time goes by, each day will bring you closer to feeling like yourself again.

Make sure you keep yourself busy doing posit

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

Following aspects would a

ve things with close friends and family. Don't sit around listening to the old "break-up" songs; they will only make you f

dd to the challenges in developing combination products:

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

eel worse.

It's very important for you to learn how to get in control of your thinking. If you sit around all day and go ov

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

r and over what happened, you will stay stuck in the past. You need to keep your thoughts focused on what you would like yo

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

r future to look like.

You're vision should be on creating the life you want, not on what you've left behind.

We all kno

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

w it hurts, we all know it's a struggle. Every time you start to drift back into the whoa-is-me thinking, feeling sorry for

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

Professional from academic institutions, pharmaceutical industries, health care indust

yourself or wondering why things didn't work out the way you wanted, STOP YOURSELF. Say out loud, "Stop It!"

The more you d

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

this the quicker you will be on the road to healing. The single most important factor that will move you closer to feeling

.

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

good again is learning how to direct your thoughts.

Become the captain of your ship, steer it where you want it to go. If

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

Companies that provide selfless information through particip

you master the technique of controlling your thoughts; you will be on the road to a happy future in all aspects of your life

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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