Advice Pool - Reference and Education

Have you ever gotten into a debate with someone who was clearly incorrect in

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

their thinking and yet they would not yield to all the good solid evidence

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

Examples of combination products may in

efore them? Sometimes hard headed individuals will stand against their belie

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

f systems or educational knowledge and refuse to consider or observe the act

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

al. Why is this.

Recently, I had complete won a debate with a well-educated

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

Combination pro

gentleman and he would not concede my point, rather said we disagree and ha

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

different perceptions. BS, I told him, I have won the debate on all counts

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

and you know it, you lose.

Accept your defeat, as I have intellectually cre

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

med you in this debate. I win. You have lost and your additional arguments a

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

re simply invalid. You are using lawyer techniques going back to definitions

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

selective use of history, yet in complete denial that the race is over, I w

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

Following aspects would a

on. You are now in the "agony of defeat" motif is all.

I watch humans all t

dd to the challenges in developing combination products:

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

e time do this. Always justifying their belief systems, even in the face of

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

evidence to the contrary, they follow their mistakes to their graves if need

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

be. It is human nature. Indeed the reciprocal here of what you have placed u

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

pon me. My mirror is clear, how does yours look?

Remove the fog. Move on. B

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

Professional from academic institutions, pharmaceutical industries, health care indust

t alas, a human convinced against their will is of the same opinion still. I

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

certainly hope this article is of interest and that is has propelled though

.

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

. The goal is simple; to help you in your quest to be the best in 2007. I th

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

Companies that provide selfless information through particip

ank you for reading my many articles on diverse subjects, which interest you

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.advicepool.org.ua/article/222143/advicepool-Humans-Often-Will-Not-Admit-When-they-are-Wrong-Especially-the-Educated-Ones.html">Humans Often Will Not Admit When they are Wrong; Especially the Educated Ones</a>

BB link (for phorums):
[url=http://www.advicepool.org.ua/article/222143/advicepool-Humans-Often-Will-Not-Admit-When-they-are-Wrong-Especially-the-Educated-Ones.html]Humans Often Will Not Admit When they are Wrong; Especially the Educated Ones[/url]

If you're seeking to enhance your relationship or even save your marriage, then smoothing out that bone of contention called communication is your one sure route to lasting harmony and bliss.

Tags

Links

Advice Pool - Humans Often Will Not Admit When they are Wrong; Especially the Educated Ones

Related Articles: