Advice Pool - Reference and Education

Watching the behavior of those who participate in forums is quite fascinating inde

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

ed; in fact some of the human behavior is quite obvious and predictable indeed. On

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

Examples of combination products may in

tactic which you will see from veteran politically savvy forum participants is to

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

change the tone and act like they are giving genuine advice or wisdom, to take th

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

upper hand and set the other person into a listen mode like a Father-son conversa

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

Combination pro

ion. Here is what it looks like so you will know it when you see it;

Jen states;

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 was genuinely trying to offer you a small bit of wisdom I've picked up over tim

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

. It applies to people of any age."

Of course this does not always work and somet

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

mes someone who has studied a little human psychology will catch it as this person

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

has who stated;

“Incorrect you were trying to move the conversation to Father-so

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

mode from a straight line conversation of equals. You know if you read back all t

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

Following aspects would a

e posts it is truly amazing all the things you have called others or inferred on t

dd to the challenges in developing combination products:

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

his Blog. I cannot accept your "genuine-ness" however your wisdom is an interestin

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

point; I see where you are coming from. But fear is not what invoked my flight or

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

"fight" response in this case. In this case I am defending my observation and perc

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

eption of that observation and the concept of how to best fix the problem (mentori

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

Professional from academic institutions, pharmaceutical industries, health care indust

g) in my estimation from all my experience and wisdom.”

Now the other participant

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

has indeed flipped the comment and turned it around so they can take the upper han

.

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

d and give out advice. Interesting all the flip-flop primate politics on the Inter

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

Companies that provide selfless information through particip

et Forums these days isn’t it? Have you participated lately? Consider this in 2006

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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