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Just in Time Distribution was a buzzword to solve all the worlds transportation and distribution problems and lets loo

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

k at how it is working now? In theory it makes sense to have Just in Time and with Fed Ex and other super streamlined

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

Examples of combination products may in

ystems it works fairly well when everything it working. Currently those companies who wish to guarantee next day servi

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 simply put their manufacturing facilities next to a Fed Ex regional hub or in Memphis itself or perhaps at one of UP

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

many mini-hubs or in Louisville, KY.

But wait what happens when there are severe weather issues and you need you par

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

Combination pro

yesterday and the flights cannot be made and your P1 (priority 1 freight) ends up on a P2 or P3 timetable? So much fo

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

r the World on Time in this just-in-time theory world. Of course you are saying that is not the norm, usually things c

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

n be there the next day.

Yes, usually and yet as many companies attempted to streamline their distribution systems, i

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

ventory warehouses and cut costs, there were fewer centers in which to send the stuff from. Yes, the computer shows a

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

art on the computer in Milwaukee, WI and one in Orlando, FL. But they are having celebration riots in Miami due to the

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

death of Castro and they are iced in Wisconsin. Meanwhile you need the part in San Antonio, but there is a Hurricane c

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

Following aspects would a

oming ashore in Galveston again.

Meanwhile once the traffic and crowds are gone, they learn in Miami distribution cen

dd to the challenges in developing combination products:

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

er that the RFID tag reader made a mistake it is not there. So you wait for the ice to clear from Milwaukee and it wil

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

be on the plane Friday on its way. Oh, but the place is closed on Saturday and you they can install it on Monday. Mon

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

ay comes and it is the wrong part. But the good news is we found the part we need in Los Angeles and one in Tokyo too?

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

Piece of cake; Tuesday rolls past and it is Wednesday and they are busy, but can get you out first thing on Thursday.

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

Professional from academic institutions, pharmaceutical industries, health care indust

On Thursday the part is in, but then they discover another problem and order that part by 4 PM and it will be shipped

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

out from Raliegh Durham NC. Everything works great with the Just in Time theory this time and you have your part by Fr

.

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

day and they actually almost finished fixing it all by Friday night, not quite you can have your Luxury Sports Car bac

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

Companies that provide selfless information through particip

on Monday. Moral of the story; Just in Time is not all it is cracked up to be in real life. 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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