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We all see the cell phone plan deals and minutes offered in advertisements. Whether it may be television, new

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

spaper, magazines, or radio we all by now have seen the minutes offered with family plans and so forth.

The

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

Examples of combination products may in

most popular of plans available at this current time is the 1,000 minute cellular plan. 1,000 minutes may see

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

m like a lot and almost endless for your wireless calling consumption but in reality this may be far from a w

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

orry free calling plan.

A very important part of the decision process should be based on how many people are

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

Combination pro

going to be using the calling plan. More importantly, who is going to be using your calling minutes. Are the

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

users teenagers? How many of your children will be using the plan? Do you or your spouse frequently make cal

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

s? How long is the duration of most of these cell phone calls?

A somewhat simple way to calculate how many m

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

inutes you are going to need or may be lacking is to basically make some rough estimates of all possible user

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

's monthly usage by rounding off into hours. Yes, hours not minutes.

In an Example:

Bob (Husband) 4

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

Hours

Sally (Wife) 3 Hours

Sue (17 years old) 5 Hours

Joe (15 years old) 4 Hours

FAMI

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

Following aspects would a

LY TOTAL: 16 Hours

Okay, so now you have put together the accumulated usage estimate. Simply dissect these

dd to the challenges in developing combination products:

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

hours into minutes. To do this is quite simple. All you have to do is multiply the hours by 60:

16 x 60 Min

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

utes = 960 Minutes

The end result will be the amount of minutes you expect to spend on your cell phone plan

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

ach month. So with this family using 16 hours a month we have come up with 960 minutes.

In this scenario th

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

e family is just right for a 1,000 minute plan and that is lucky being you can expect to pay as much as .30 c

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

Professional from academic institutions, pharmaceutical industries, health care indust

ents per minute after you go over your amount. In any case you should always use some math and fair estimates

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

of how much cellular calling you really will be making.

In all cases the easiest way to pick a plan, especi

.

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

ally for a single cell phone plan is to divide any plan by 60. Dividing by 60 you are dividing the minutes gi

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

Companies that provide selfless information through particip

ving you an answer that equals in hours giving you a more realistic look at how much you will be able to call

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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