Actual - Writing and Speaking

Article writing can be a fun exercise, and creating suspense can be even

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

more fun. All it requires is a little planning and the ability to...wel

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

Examples of combination products may in

l, let’s get to that in a minute.

First, make sure your article will co

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

tain enough information to satisfy your reader. It doesn’t matter how mu

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

ch suspense you add to your article, if you don’t satisfy it your reader

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

Combination pro

will be disappointed and will think you’re not much of an expert. His o

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

her opinion of you will go down a notch or tow instead of up.

Second,

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

make sure it’s well-written. If people can’t follow along, you’re not go

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

ing to gain any fans. Well-written means not only using clear and comple

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

e sentences, but also avoiding buzz words, esoteric terms, acronyms, and

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

other reader irritants.

Third, Make sure there is a clear introduction

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

Following aspects would a

, a good body with a few good backup points, and a good conclusion. Some

dd to the challenges in developing combination products:

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

imes you can jump right in or skip a conclusion of the end is good enoug

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

h as a stand-alone, but most of the time a conclusion will be necessary.

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

And lastly, I will get to the key ingredient I almost gave away in the

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

beginning...the ability to give the most important piece of information

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

Professional from academic institutions, pharmaceutical industries, health care indust

at or near the end. See how well it works? You’re still here.

In fact,

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

this entire article was an example of all the principles outlined here.

.

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

t has a one-paragraph introduction, a multi-point body, and a conclusion

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

Companies that provide selfless information through particip

, which you are reading now and which I will now conclude. Happy writing

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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