Digg It - Business

THE NEW CALENDAR

We have been following the Christian Gregorian Calendar for almost 2000+ years now and it sure is a non standard way of counting the days, months and years as it is based on the solar year which is defined by the time taken for the earth to make one complete

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

revolution round the sun.

Now, this calendar becomes klutzy because of the fact that the twelve months don't conform to an equal number of days and also the leap year factor of Feb 29 which is necessary every four years to keep it in synch with the solar year.

Why is it nece

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

Examples of combination products may in

sary to be in synch with the seasons for a calendar whose basic purpose is to count time? Wouldn’t it be convenient and useful if we had months of equal number of days?

My simple and humble view is that we need to have a calendar, completely devoid of religion, seasons, and a

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

ll such external elements, purely based on a standard format of days, weeks, months and years that conform to some equality.

Eg; A day is comprised of 24 hours and thats fixed. A month needs to have a fixed number of days and weeks, and a year needs to have a fixed number of

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

ays, weeks and months.

A Calendar having 13 months of 28 days each would give us a year of 364 days. Furthermore it would fix the number of weeks in each month to 4. If we start the year on a Sunday, eg Year 2006, then every month will begin on a Sunday. A week will continue

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

Combination pro

to have its 7 days from Sunday to Saturday as before.

This NEW year will now have 1.25 days less than the Gregorian Year. This means that the seasons will shift through the year, slowly but steadily, until the calendar returns to its original start season every 291.2 years. T

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

is time frame amnounts to almost ten generations of humanity assuming that a generation is born every 30 years, approximately.

Now a year will have a fixed number of 364 days, within 13 months. Each month will have four fixed weeks startng and ending on the same day thus givi

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

ng 28 fixed days.

While it s easy to suggest and look at the feasibility of acceptance of such a proposal one has also to review what kind of impact such a change wll have on the life of the World.

While clocks wll not be affected in terms of Hours, Minutes, Seconds & Degree

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

, they will still have to be adjusted to display the correct New Month and Year. This can have many ramifications in that almost all digital ekectronic equipment from hand held pocket calculators, to mobile phones, to Computer Hardware, Software to Microwave Ovens, Washing Mac

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

hines, TV sets, Video, CDAudio & DVD recorders use the day and year feature within them for executing various user desired functions. In fact it would have been the ideal opportunity to have been able to execxute such a change during the Y2K year when all software and related

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

unctions had to be converted to conform to the new Millenium year format.

In any case this will only be an once and for all exercise that wll be needed to be applied to all existing electronic digital devices. Future manurfactured equipment can easily adapt to the new system

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

Following aspects would a

without much difficulty.

By this we also gain much in terms of equality of the number of days within a month whch is useful because months are used for computing many financially related events in life, viz; rent, pay, payments, mortgages, etc etc.

One good thing that will c

dd to the challenges in developing combination products:

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

me out of it is that we will have a 13 month pay every year although we will also have to pay 13 months rent and mortgages for the same period.

No doubt this change will certainly effect anniversaries and also marketing trends which usually compare the performance of products

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

and services of specific months or quarters against previous years. Biut this can be overcome by still maimntaining the Gregorian Calendar side by side with the new one show9ing the corresponding dates, months and years. This is nothing unusual as it is already being done wit

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

the Islamic Hijri Calendar followed by the Muslims across the globe, the Buddhist, Hindu, Chinese and Jewish Calendars too. Of course the calendar will be cluttered with multiple dates on each square but that will settle with time and people will get used to reading it off 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 cuff with time.

NEW Calendar I have spent some time on MSExcel and was able to conjure up a possible NEW Calendar based on the 364 day year of 13 months, each containing 28 days.

Started off with Jan 1 1900 taking it to be the first day of the first month of the year 190

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

Professional from academic institutions, pharmaceutical industries, health care indust

of the NEW Calendar Year and defined some date manipulation formulae to create a conversion of any date between Gregorian and the NEW Calendar thus coming up with a format for the new system that could be implemented at any time we choose since it originates from 1-1-1900 Gre

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

gorian and hence takes care of all dates since 1900.

Based on the conversions I get the following eqivalents:-

Aug 21 2005 G = 1 Day of the FIRST (1) Month of NEW Calendar Year 2006
Jan 1 2006 G = 22 Day of the FIFTH (5) Month of NEW Calendar Year 2006
Sep 17 2006

.

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

G = 1 Day of the FIRST (1) Month of NEW Calendar Year 2007
Jan 1 2007 G = 23 Day of FIFTH (5) Month of NEW Calendar Year 2007

Today, Dec 25 2005 G = 15 Day of FIFTH (5) Month of NEW Calendar Year 2006

G = Gregorian

Interesting stuff to ponder over.

One good thing

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

Companies that provide selfless information through particip

that comes out of the NEW Calendar is that we lose 1.25 Days for every single NEW Year since we were born. Not bad for age freaks, I guess?

I have the spreadsheet available and can send it to anyone who is interested in researching it and bashing it up for better or for worse

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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