Advice Pool - Reference and Education

If someone believes they are better at something they have a better chance of displaying such traits or

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

succeeding thru expectations right? Sure that makes sense. If someone is told when they are young that

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

Examples of combination products may in

they have royal bloodlines in their ancestry could this help them succeed? Does that DNA really make a

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

ny difference in their ability to compete?

It is funny these questions aren’t they? And along with tha

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

phrase; Believe to Achieve, they do make sense. What about a blind study? What happens when you have a

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

Combination pro

child who is never told of royal lines and you watch to see if they are over achievers or perform at t

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

he average level or even below? That might be interesting to prove a point. Well guess what? I have roy

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

al lines and did not know it until I was nearly 40 years old.

Now then judging my genes only in hindsi

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

ht of accomplishments, I believe that they are not so bad, in fact they have served me well or allowed

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

me to use them to their full potential. Now one could ask; could you have accomplished all that with le

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

sser genes?

Actually the funny thing is “I” believe I could have, I would have only had to work harder

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

Following aspects would a

, which sometimes I did when I had somewhat inferior genes for a given task you see. For instance as a

dd to the challenges in developing combination products:

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

printer in Track, my muscle twitch was not as fast as a Black Athlete, thus hard to keep up, he was sup

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

erior in that test of ability by far.

I had to condition myself more, and train much harder you see. B

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

ut perhaps the abilities of the mind to believe I could propelled me to do just that? But that cannot h

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

appen without strength of character, drive and belief in self or for some a higher power. I guess my po

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

Professional from academic institutions, pharmaceutical industries, health care indust

nt is this, maybe there is something too the Royal Bloodlines that makes these folks rise to the top or

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

over achieve as if a character flaw? Or maybe I am an anomaly? But either way, I still believe and wil

.

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

l always believe that human will is the key. And no matter what genes you have you must make the best o

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

Companies that provide selfless information through particip

f them and never give up. That my friend is what makes a winner and nothing else. 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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