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Can you teach me a thing or two?

Have you been asked this question many times and have tried 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

r best to answer? This is my personal response...

That my friend is the wrong question to ask! W

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

Examples of combination products may in

y? It goes to show that you are faithless and not confident of the life-changing opportunity or o

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

portunities that you're offering, and the answers you find to this question will ultimately lead

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

ou to failure.

The answers you might get are not wrong... The mindset that has caused you to ask

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

Combination pro

that question is. Very few people actually realise this, and very few sponsors even observe this!

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

They will try their best to answer you... But the person who asks such a question is obviously n

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

t coming from a position of strength, let alone have confidence in whatever he or she is promotin

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

.

At the subconscious level, he or she is fighting a losing battle... Beware!

What then is the

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

ight question to ask? E.g. "How do I go about showing someone what a wonderful and life-changing

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

pportuinity this is?"

Can you see the difference?

So, let's focus on asking ourselves the right

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

Following aspects would a

questions. Even when you ask yourself quietly in your head or under your breath, be aware of the

dd to the challenges in developing combination products:

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

questions you ask, and see from what kind of mindset they stem from! The questions we ask ourselv

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

s can make or break us. So, be aware!

Asking the right questions will set our mind in the right

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

r wrong direction. Be wise with your thoughts. May they never limit your vision =)

You can be ve

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

y rich or very broke, but that's not going to stop you from reaching high levels of success if yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

r mindset is not limited by whatever situation you're in!

Constantly check the questions you ask

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

privately or in public. Start asking the correct questions consciously & religiously and you'll s

.

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

e a change in your mindset very quickly! When your mindset is changed, your life will change too!

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

Companies that provide selfless information through particip

This works & I hope this article will bless you!

Happy Questioning Your Way To Success Unlimited

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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