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If you are considering running a car wash fundraiser for your nonprofit gro

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

up you may wish to consider the hours of operation of your car wash fundrai

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

Examples of combination products may in

ser on a busy sunny Saturday. Obviously you will pick a busy location and

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

place, which has a water outlet and plenty of room to do the car wash fund

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

raiser.

Once you have all those things under control you want to determine

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

Combination pro

how many kids you have that can help you wash the cars and it makes sense 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

o break them into shifts. If you have a high school band with 40 kids then

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

you can break them into four shifts of 10 kids each no more than two hours

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

long and if you wanted to you can run your car wash for eight hours you act

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

ally could.

However, this is probably not necessary because the peak time

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

for carwash fundraisers is really between 10 a.m. and 2 p.m. and the rest o

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

Following aspects would a

f the time should be reserved for the parents cars who drop off the kids an

dd to the challenges in developing combination products:

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

pick them up or last-minute stragglers who came back later because the lin

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

es were too busy during the day.

If you have a huge group you may want to

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

un the car wash fundraiser 30 minutes early to wash all the parents cars.

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

And you may wish to run it an extra hour or two in the evening. I do not r

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

Professional from academic institutions, pharmaceutical industries, health care indust

commend running your car wash fundraiser earlier than 9 a.m. and it does no

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

t make sense to run it past 4 p.m.

Anything in between is free game, but 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

remember your peak periods will be between 10 a.m. and 2 p.m. and that's w

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

Companies that provide selfless information through particip

here you should concentrate your efforts. 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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