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If you ever wanted to get ahead financially… if you ever thought you wanted to get out from under a sea of debt… if you ever wondered where the money went… YOU NEED A BUDGET! But how do

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

you develop a good budget and how do you stick with it?

Developing a Workable Budget

Review your last 12 months of check registers. If you find any cash withdrawals without an expl

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

Examples of combination products may in

anation other than “miscellaneous”, you must record all cash transactions for the next 30 days. It is imperative that you know where ALL money goes.

Insure you can account for each of

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

the last 12 months of deposits written in your register. If not, find out what they are. You must know all incoming monies.

Beginning at the top in the left hand column of at least 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

column note pad, write all income source labels down the column-- i.e. INCOME: Wages, Bonuses, Other, Total Income, etc. Below this enter the obligations found in the check registers

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

Combination pro

such as: Mortgage/Rent, Food, Insurance, Utilities, Phone, etc. Don't forget periodic expenses such as: Home or Auto Repair, Other Transportations, Entertainment, Gifts/Donations, Healt

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

hcare, Property or Other Taxes.

Leave a couple spaces labeled "Miscellaneous" and "Total Expense".

Find the payments you have made in the check registers for each expense. Enter the

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

mount on your budget pad column 2. For irregular amounts take a three or more month total and divide by the total months. For annual or semi-annual expenses divide by 12 or 6 to get a m

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

onthly amount.

At the top of your budget pad, label the other two columns... "Actual Expense" and "Difference".

At the end of each month, enter the actual total for each expense. Det

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

ermine the difference between budget column and actual column.

If there is a difference either adjust the budget or determine a way to reduce this item.

Motivation To Stay On A Budg

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

t

Step 1: Write down specifically what you are trying to do and by when. It must have a concrete time frame, it must be written down, and it must be specific and realistic. For example

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

Following aspects would a

wanting "more money " is not the same as "10% increase over last year by October first."

Step 2: What are the obstacles? What are your inadequacies? What do you need to get there that

dd to the challenges in developing combination products:

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

you don't already have? What is it that's blocking you? Why aren't you already there?

Step 3: Write a plan to overcome EACH obstacle. List your action steps 1... 2... 3... etc. for ea

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

ch obstacle from above. Be as specific as possible. What will it take to get you past the obstacle that is blocking you from what you want?

Step 4: List the benefits to you. There is n

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

such thing as something for nothing. You must replace a thought process and resulting action with a new thought process that will produce a desired result. There must be a benefit deri

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

ved of sufficient value and meaning to you alone to be worth the effort necessary to do this and to overcome the resistance to change.

Step 5: Is it worth it? This question must be ans

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

Professional from academic institutions, pharmaceutical industries, health care indust

wered very carefully and honestly. If the answer is yes, do it and DO IT NOW! However, if the answer is no, if the benefit derived cannot muster the desire to overcome the obstacle, you

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

have three choices:

Change the goal thereby reducing the obstacle; and/or increase the benefit to make it more meaningful. Drop the entire issue and get on with your life without f

.

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

eeling guilty.

______________________________________________

Bonus Step: If you really want to stay motivated you will have to reinforce your efforts through affirmations or self tal

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

Companies that provide selfless information through particip

k. In a few places around the house, place a simple statement of what you are trying to do and repeat the statement as often as possible. The more often you do it the faster the process

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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