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If you are not already, did you know that you too can beco

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

me an ezine publisher?

First of all, I want to share with

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

Examples of combination products may in

you the first and most important thing a new ezine publis

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

er should do.

Hang on, because this can get technical and

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

complex. Here it comes:

Start - that's it, start.

So ma

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

Combination pro

ny would be ezine publishers become overwhelmed with the p

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

ospects of building a list and finding content that they 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

ever start.

Intimidated by others

Would be ezine

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

publishers hear about some of the people with a list of 10

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

000, believe that they could never get to that amount, and

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

so never begin.

Here's a powerful secret:

Before you ha

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

Following aspects would a

ve a subscriber base of 10,000, you have to have a subsrib

dd to the challenges in developing combination products:

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

r base of 1,000. Before you have 1,000 subscribers, you ha

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

ve to have 100. Before you have 100, you have to have 10.

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

And, as I hope you have guessed by now, before you have 10

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

you have to have... one. Start with one if you have to, ev

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

Professional from academic institutions, pharmaceutical industries, health care indust

en if that one is you. Just start.

Start with three subsc

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

ribers, even if those 3 are your spouse and your parents.

.

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

ust start.

Remember this and then go live it:

You do not

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

Companies that provide selfless information through particip

have to be good to start, you do have to start to be good

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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Main Subject - Ezine Publishing: You Don't Have to Be Good to Start, But You Do Have to Start to Be Good

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