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What foundations have you built in the past? I have built a family, a business, a writing c

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

areer, a consulting career all based on the fact I wanted to get there on my own terms. No

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

Examples of combination products may in

one really made the decision for me, I just went for it (so to speak)

Even though I went f

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

or it, there was some ground work that had to be completed before the final task could be p

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

t in place. You would not want to put your shoe on first and then your sock. It would be a

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

Combination pro

bit uncomfortable. However, I could put on my socks and not pull them all the way up before

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

I put on my shoe. The point is that although it might be a bit uncomfortable having wrinkl

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

ed socks, I can still put on my shoe and walk. Yes, I will likely get some blisters on the

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

ay but I will be moving in the right direction and I will still get to my goal.

So what do

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

es building a foundation have to do with all of this? You can plan your foundation, and cho

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

ose what must be in place in order to hold everything in place. The more solid the foundati

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

Following aspects would a

on, the less likely you will topple later on. You can build a foundation that is solid enou

dd to the challenges in developing combination products:

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

h to get moving. You do not want to spent all of your time planning and hope that you will

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

"some day" get around to building your business or your wealth.

Build what is necessary an

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

d then get moving. If you need to go back and reinforce something, then make sure those pie

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

ces are reinforceable. If something cannot be reinforced, then that should be one of the th

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

Professional from academic institutions, pharmaceutical industries, health care indust

ngs you do to perfection. Nothing is perfect, however, building a foundation on sand does n

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

ot work either. Find a middle road and put the essential pieces in place, then if you have

.

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

to go back and pick up other parts, you can. Don't get mired in inertia because your founda

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

Companies that provide selfless information through particip

tion is not complete. Just analyzed what is needed and get on with the rest of the building

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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Money is hard to come by these days but if you have the will to really make it through then it is still very possible to make money and to make even more as each day goes by. The problem lies if you do not know where to start much more if your problem is the fact that you do not have money to begin with. How can you put up a business or invest in something when you do not have capital to begin with? Money can be found.

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