Advice You - Business

Each year billions of dollars are pumped into space research and many peop

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

le here on Earth feel that that it is a waste of money because we could be

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

Examples of combination products may in

doing other things here at home such as finding a cure for cancer. Howev

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

er, what many people may not realize is that the space research we do ofte

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

n will help in many medical endeavors. Research and development here on e

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

Combination pro

rth combined with what we learn in space in zero gravity can help us achie

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

ve more, faster.

Public relations for space research needs to promote thi

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

s fact and educate our citizenry as to how much good the space programs ar

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

e doing. It makes sense to have open communication lines with all major me

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

dia outlets and explain the historical transfer technologies, which have c

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

me from the space program and solve many of the things, which had previous

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

Following aspects would a

ly plagued the human species.

What people need to know is that it is not

dd to the challenges in developing combination products:

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

an either or proposition. Money spent in space research does help here on

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

earth and this fact must be promoted. Cutting back on the space budget f

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

or research is a very bad idea if we are to press on with new technologies

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

Everyone should be very proud of the space program and the space researc

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

Professional from academic institutions, pharmaceutical industries, health care indust

h, as well as all the research and development the goes on here on earth t

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

o make it all happen.

Positive public relations programs and strategies a

.

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

long with space research goodwill is exactly what is needed for our societ

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

Companies that provide selfless information through particip

y to understand all that we do in space. Please consider all 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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