Summary - Relationships

What is good-mate-itis? Good-mate-itis is a disease that we get when we are well-nurtured, well-supported, and very content within our r

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

elationships. We feel little or no challenge to make things better, and we feel it can’t get any worse. We begin to take each other fo

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

Examples of combination products may in

granted. We “know” our mate will always be there, so we fall into a deep sleep. We are on automatic. Sex is the same, dinner is the sam

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, we say the same things, we go to the same places, we smile at each other the same way, we forget the buttons we push and the feelin

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

s we hurt because we “know” they will always be there. BEWARE! This is the time when love falls apart. It falls apart when we get good

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

Combination pro

mate-itis.

Okay, now that it has been diagnosed how do we cure it? Well, that depends on who has it and who’s doing the curing. In

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

a perfect world the people who have developed good-mate-itis would realize they have it and immediately work to cure it. They might w

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

ite down every little thing they appreciate about their mates and send it in a card. They might plan a romantic night without distractio

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

s, which includes a new meal, a new drink, and a new move. They might even make an extra effort to try a different response when their

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

mates push their buttons. Most importantly, they do whatever it takes to cure their good-mate-itis.

In the world in which we live

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

it may take a little more to cure this ghastly disease. It may take the good mates’ help to find the cure. The good mates are probabl

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

Following aspects would a

the ones who will notice the disease first, but they may let it go untreated for quite a while before they seek a cure.

The first

dd to the challenges in developing combination products:

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

thing to do is to talk about the illness. Mention, that you have seen a change, and that you are not happy with it. If that doesn’t cur

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

the sickness, try to be an example by doing the things you would like done for you or better doing special things that you know your

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

ates will love. If this nasty disease still persists, the next step may be a bit more drastic, and hopefully you won’t have to use it.

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

Well, here it goes… gently and I mean gently, show the person with the disease what it would be like if they didn’t have you to take for

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

Professional from academic institutions, pharmaceutical industries, health care indust

granted. Maybe you’ll have to take off an afternoon or evening by yourself. Maybe you’ll have to stop cooking soul- soothing meals. Ma

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

be you’ll need a weekend off on your own or with your friends. You may have to think of your own concoctions for a cure, like grandma us

.

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

ed to do. Nothing to severe, just a gentle reminder that you are still around , and that you deserve to be acknowledged. PLEASE, PL

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

Companies that provide selfless information through particip

ASE, PLEASE, don’t play dangerous games that will get you into trouble (you know the ones), just try gentle, gentle reminders.

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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Summary - A Cure for Good-mate-itis

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