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1. Choose a task you have been meaning to get done but never seem to get around to doing

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

. You must be able to see and touch something that represents this task to you. It could

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

Examples of combination products may in

be a note about making a phone call or a file folder containing everything you need to s

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

art writing a report, or a stack of material you have been meaning to file.

2. Pick

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

up the object, the note, the stack, the paint can…whatever it is. Preferably pick it up

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

Combination pro

10 times a day; but at least once a day. Hold it and look at it.

3. Say aloud th

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

following words. “I don’t want to...(fill in the blank with words similar to these the

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

ollowing)...call this client (specify his/her name), fill out this form, write this ch

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

ck to (specify the name)." "Nobody can make me...(say again what you are not doing.)" "

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

I will do...(say what it is once more) when I am damm good and ready to do it!"

4.

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

ay attention to your creative (or resistant) thoughts as you do this process. Laughing,

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

Following aspects would a

iggling, or stomping your feet during the process is okay too.

5. Repeat this proce

dd to the challenges in developing combination products:

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

s daily for at least 5 days — unless of course you complete the task before then.

6

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

. If the job still isn’t done by now, you certainly know why it isn’t done and/or what r

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

sources you need to do it. Decide whether or not you will actually do the task.

7.

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

o it, ditch it, or delegate it appropriately.

This works because procrastination is

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

Professional from academic institutions, pharmaceutical industries, health care indust

often a sign of ambivalence. Part of you does want or needs to do the task, but another

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

part of you, usually a silent part, does not want to do it.

Giving the resistant pa

.

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

t of you a chance to speak, as well as acknowledging that you have the power to complete

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

Companies that provide selfless information through particip

the task when you are ready resolves the impasse.

Copyright 2004 Laurie Weiss, Ph.D

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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