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I've discovered that it's very easy to let ourselves stay grounded to a comfort zone, even though our whole being is shouting at

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

us for a decisive change!

Woah! What do I mean?

See, sometimes we know that if we keep at doing what we always do, we'll be get

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

Examples of combination products may in

ing nowhere until we change our course of action. Yet, we've conveniently slipped ourselves into the COMFORT ZONE...

We know we'

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 had enough! But... Yes, a BIG BUT! ... We're not willing to change our actions because it has become a habit!

We are habitual

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

eings and this fact is not new. I have learned that if we have a bad habit that we wish to overcome, the fast & effective way to

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

Combination pro

o that is to cultivate a good habit to replace it!

Yes, easier said than done! Why? Most of us can identify what's holding us ba

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

k and what's necessary for us to do. BUT! ... We are just not ready to GET OUT OF OUR COMFORT ZONE!

Our unwillingness to change

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

sually stems from our being comfortable with where we are at the moment even if it hurts ourselves to be in whatever situation we

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

re in.

Some will say, "I want to change! But I just can't!"

My response: How much do you want to change? Are you not being able

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

to change because you're too STUCK in certain ways or conditions? It's really like hearing someone telling you YES, but saying NO

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

on the inside... Check your comfort zones and you'll find out who your worst enemy lies!

"I'm not sure what will happen if I wer

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

Following aspects would a

e to do something differently! Hmmm... Should I proceed?"

Hey! Nobody can tell me the results that I will get if I did not get t

dd to the challenges in developing combination products:

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

proceed with whatever ideas that are floating in my head! Nobody needs to tell me... Right?

We will not know if something works

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

until we've tried it. We then track what we have tried to become wiser about the consequences that our actions will bring about.

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

owever, without even starting to test for results, what is there for us to track? In the end, we will never know how things will

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

urn out unless we actually take the risk to test the waters!

Had enough of going in circles in your life? Do you want to have a

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

Professional from academic institutions, pharmaceutical industries, health care indust

efreshing change? Then... here's what I dare you to do! Get out of your comfort zone and do the necessary! Take action! Be it to

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

ind out what you need to know... Be it to do a research on some proven knowledge, or just taking a step to do a totally new exper

.

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

ment to test your hypothesis... JUST DO IT! Take the risk and do what is necessary!

Don't let what is comfortable prevent you fr

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

Companies that provide selfless information through particip

m moving forward, taking risks and doing what is necessary! Remember this: Success follows whenever the necessary things are done

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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