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I am trying to create a discipline where I blog daily. This alone requires effort and commitment. But isn'

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

t that what our lives ought to be about especially if we are trying to achieve our goals? That's just a te

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

Examples of combination products may in

ser.

Anyways, yesterday was another day when I learned something. If not learning, I needed to recall som

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

ething I had read.

I am a person who likes to try things out. Positive things. Sometimes when I do and pe

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

ple around me make what you call 'uncalled for comments' it cuts right through me. And trust me, I like to

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

Combination pro

be agreeable with everyone. Okay, is this the part I say I am learning that it ain't possible to be agree

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

ble with all? I thought so. Yesterday I just learned it on a higher grade. I needed to graduate:-) And I d

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

id.

The lesson dawned on me as I was being told of someone's catty comment and action of trying to change

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

what they thought I had done wrong. I wanted to go defend why I had done what I had done. Plus why I thoug

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

ht it was right. But as I walked away vowing to approach the person, it dawned me. I keep saying dawn I gu

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

ss it really did open my eyes to a new light.

Lesson: I don't have to defend myself every time I do somet

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

Following aspects would a

ing outside the box and somebody doesn't like it. Some people will just never get it. And its meant to be

dd to the challenges in developing combination products:

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

just like that. Ce la vie!!! Even if you do something that is highly positive, they will always see the ne

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

ative. They will always seek to drag you down.

But, I have many a times abandoned my dreams at the altar

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

of negative thinking because l took a portion of that thinking from someone who really has hell for a life

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

In the moment I did that, I always abandoned what kept me going - my passion.

Yesterday, I decided I wa

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

Professional from academic institutions, pharmaceutical industries, health care indust

s not here to please anyone. I will think outside the box. And if you don't like it, well my condolences.

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

ut this is not to say I won't reason with you because sometimes someone will see the pit before I do. Just

.

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

between me and you, rarely is there a pit. It usually is someone trying to pull you down.

So go out - t

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

Companies that provide selfless information through particip

ink out of the box, and let they that shiver in their boots for fear of trying new things enjoy the view:-

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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