Just Answers - Writing and Speaking

So you love to write and you found out about submitting articles on the worldwide web. You ask yourself whether you can actually get good exposure from spending time wr

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

iting articles and whether it’s worth the effort. After all, like me, you’re a nobody from nowhere. But then again, at one time so were all the celebrities and people

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

Examples of combination products may in

n the current media. Well, I started writing articles a little less than a year ago, and when I started, I asked the same questions. Now that the Fox TV interview has

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

aired on television and on their website, I am thoroughly convinced that, yes, article writing is worth the effort. Read on.

On a chilly night Monday, December 5, 2006

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

Fox 29 TV came down to the Freehold Raceway Mall in Freehold, New Jersey to test out my mathematical theory about finding a mall parking spot using mathematics. As Gera

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

Combination pro

ld Koplan, the Fox reporter stated, “This method posits an interesting theory. But does it work? Well, we put it to the test, and it does.”

Basically, the method hing

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

s on the two complementary mathematical disciplines of probability and statistics. Much like a mortality table, which is used by insurance companies to predict how many

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

people of a certain age will die in a given year, the parking solution predicts how many cars will “die,” that is vacate their spots, within a given interval of time.

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

ust as an insurance company cannot predict who will die within a given year, only how many; the parking problem cannot predict which car of a group will va

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

cate a spot, only that one of a group will within a given time period.

The purpose of the problem was to show how, using some very basic assumptions and some minimal ma

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

hematical theory, a common frustration could be solved. In the problem, the assumption used was that the average time spent shopping during the Christmas season was 120

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

Following aspects would a

minutes. Using a mathematical curve called the normal distribution and a famous statistical theory, we can predict that more than 99% of the cars in our sample will vac

dd to the challenges in developing combination products:

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

ate the designated parking area within 180 minutes. (Remember we used the average mall stay of 120 minutes to get to this 180 minute number.)

Based on empirical data c

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

llected from repeated observations of cars pulling into and leaving parking spots, the normal curve was chosen as the mathematical model to help with this problem. More

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

over, the nature of this stochastic process (a stochastic process is a random process involving a sequence of events like here cars pulling in and leaving spots) led to

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

he conjecture that over time, the interval between cars leaving would “smoothe” out and that such interval could be calculated by dividing the number of maximum minutes,

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

Professional from academic institutions, pharmaceutical industries, health care indust

in this case 180, by the number of designated cars, in this case 20.

With this information in hand, and the basic assumptions granted, we can with confidence fit a mat

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

ematical model to the data so that reliable predictions can be made. What could be easier than doing a simple division to calculate how to find a parking spot? And you

.

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

thought math was that bad.

See video here (elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

=VSTY&pageId=3.2.1">Click here to see the video of the story)

See more at Cool Math Tricks

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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Just Answers - How an Article on Math Got Me a Spot on Fox TV

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