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Solo professionals and consult need to be sure to have as many

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

people as they can as friends who are associates in the industr

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

Examples of combination products may in

y. The solo professional consultant who bucks the system and t

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

e industry associations will find that some people will stay aw

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

ay from them and they will lose all the contacts of that partic

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

Combination pro

lar person that they could have had to help them in their busin

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

ess.

This means fewer clientele and negative word-of-mouth adv

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

ertising rather than positive referral reinforcement. Solo pro

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

essionals should not buck the system too much and they should p

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

articipate in industry associations. If they do not like the in

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

ustry associations they should participate at lease to a small

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

Following aspects would a

degree and not go negative against the industry.

Solo professi

dd to the challenges in developing combination products:

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

onals who disagree with what the industry is doing should proba

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

ly consider what our grandparents told us; If You Don't Have An

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

ything Nice to Say Don't Say Anything at All.

There is no sens

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

in making waves in the industry if you do not have to and if y

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou're going to participate in industry forums on the Internet o

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

r discussions at trade shows then you need to be cognizant of h

.

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

w you conduct yourself to benefit your objectives in your Solo

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

Companies that provide selfless information through particip

professional consulting business. Please 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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