References - Writing and Speaking

Writers often hold themselves in very high-esteem, but is it right for them to do so? The

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

re are experts who write and therefore some writers are experts. Then there are writing e

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

Examples of combination products may in

xperts who specialize in writing and words. Of course if we look at online articles on th

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

e Internet, we see a lot of people writing and claiming to be experts who are faking it.

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

In fact they are not experts at all, more like posers using "Key Wording" to at

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

Combination pro

tract clientele to their websites. So, we should not assume that just because someone pro

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

duces lots of articles that they are an expert in the field that they are writing on. Of

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

course we should also not assume that they are not an expert for they may very well be. S

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

how do you tell the difference and what is an expert anyway?

Well one online article se

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

lf-proclaimed expert believes that an expert would be someone who completes a significant

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

project that is being used by others? Okay, we assume he means people, but it could be a

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

Following aspects would a

bridge used by animals to cross a busy highway during migration too?

In any case let's

dd to the challenges in developing combination products:

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

ee where this concept or definition of expert takes us? Okay if we use this working defin

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

ition then finding the experts can be done only by way of personal resume and verificatio

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

n. For instance we must ask each online article author here:

What ha

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

ve you done or produced that made a significant change to an industry, domain or society?

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

Professional from academic institutions, pharmaceutical industries, health care indust

Then we have to ask them to prove it.

Then all we have

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

to do is verify and we have separated the experts from the non-experts.

.

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

>

It might take a lot of man hours but we could indeed separate the experts from th

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

Companies that provide selfless information through particip

e non-experts in this fashion. Is this a good idea or plan to find the experts? Yes or no

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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References - Writers, Experts and Fakers - Which are You?

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