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So often in a group you will have some one who runs around and tries to shoot down every idea

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

they come too. One must be amazed at these folks and wonder what on Earth are they trying to p

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

Examples of combination products may in

ove? Recently in an online think tank forum just such a man critiqued and idea to use a statio

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

ary bicycle in a spacecraft to keep the batteries topped off, by harnessing the energy created

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

from pedaling.

Eventually this gentleman after going on and on about what a bad idea and conc

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

Combination pro

pt this was, even though we know all astronauts should exercise, the originator of the idea st

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

ted;

Actually your critique lacks;

1.) Proof of Statement

2.) Signs of clearly not understa

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

ding subject matter

3.) Relevant Arguments

4.) Alternative Solution

Therefore your comments

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

are irrelevant and unworthy of consideration, do not belong on a think tank and clearly are in

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

need of a "Can Do" attitude. The posting of the concept is reality based and dust devils on Ma

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

s do have energy. It is plausible to harvest this energy. It makes sense to harvest energy, wh

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

Following aspects would a

ch is already there and thus practical if we can figure out how. And this is an original thoug

dd to the challenges in developing combination products:

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

t and I have searched the Internet and scientific papers and cannot find anything close anyone

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

has ever put forth, yet would like to see such research.

I find it odd that you poo poo the i

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

ea of collecting this energy rather than letting it simply blow away? Tell me dear sir; please

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

state an original idea. One, name one and post it here on the board under any category. A chal

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

Professional from academic institutions, pharmaceutical industries, health care indust

enge perhaps? You seem to be pretty sure of yourself? Show us. I have posted over 1000 origina

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

ideas and incase you do not think so. Check the dates on the posts. How many original ideas d

.

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 you come up with this week? Are you living in reality? Is it plausible you could do this, wo

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

Companies that provide selfless information through particip

ld it be practical for the human race if you posted an original thought? 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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