Advice Pool - Self Improvement

One thing about being organized is that you know exactly where the item you are

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

looking for is, at the time you need it. This is exactly what happens with an o

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

Examples of combination products may in

ganized drawer, but it is usually not the case with a junk drawer. It is just to

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

easy to just dump items in drawers, because they are out of site. Over time, a

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

this dumping continues, the drawer becomes an absolutely disorganized mess -- h

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

Combination pro

nce the term, "junk drawer".

Drawers should never be stuffed with gadgets and u

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

tensils. They should be purposely organized, storing items that are easy to acc

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

ss. Your drawers need to be labeled with a name besides "junk". They need a re

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

l purpose like: utensil, silverware, knife, office accessory, and so on. Everyth

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

ng in the drawer should be used on a regular basis (at least once every two to f

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

ur weeks) and should be easy to access.

Is your drawer up to the test?

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

Following aspects would a

Let's see:

Take everything out of your utensil or gadget drawer an

dd to the challenges in developing combination products:

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

put these items in a box.

Leave this box on your countertop or on a shel

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

Every time you use one of the items, put it back in the drawer. Do

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

his for two to four weeks.
The items that are left in the box ar

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

either duplicate items (you couldn't find it previously, so you bought it again

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

Professional from academic institutions, pharmaceutical industries, health care indust

) or items you don't need. In other words, what's left is probably the "junk" t

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

at was in your junk drawer.

Now you need to decide whether to get rid of these

.

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

tems, or to keep them in a different location. Be realistic here: if you didn't

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

Companies that provide selfless information through particip

use these items in a month, you probably won't use them at all. Act accordingly

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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Do Unto Others as You Would Have Others Do Unto You. Great decision-makers use participation because it improves the chances for a fast, smooth and successful implementation.

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