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Let’s say that your net monthly income (that’s after taxes) is $2500.

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

Your monthly debt payments are $600. Divide $600 by $2500, and you

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

Examples of combination products may in

ve done it.

600 ? 2500 = .24 (24%)

So, how do you figure out your d

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

ebt to income ratio?

1. Take a look at your last month’s bills. Ad

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

up all the fixed monthly expenses (rent, mortgage, car payments, ins

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

Combination pro

rance, gas/electric, etc.)

2. Check your credit card bills and add

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

up the minimum payments required on each

3. Figure out your monthly

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

take-home pay (net salary - meaning after taxes, etc.)

4. Divide th

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

monthly fixed expenses by monthly income

Now, how much debt is too

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

much? The majority of debt settlement and credit counseling companie

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

generally agree that debt expenses should be no more than 25% of you

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

Following aspects would a

income. A ratio of 10% or less is ideal. Actually, no debt is the

dd to the challenges in developing combination products:

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

best but who are we kidding….

If you are carrying a debt load of mor

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

that 25% it’s time to take action. You may even want to get some ty

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

e of debt help by looking into a debt settlement or credit counseling

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

program. If you own real property, you may want to look into some t

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

Professional from academic institutions, pharmaceutical industries, health care indust

pe of debt consolidation loan.

To learn more about your options and

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

anaging you debt, log onto .

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

efoptions.com">www.debtreliefoptions.com.

Jon Noble
Staff w

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

Companies that provide selfless information through particip

iter
Debt Relief Options
asktheexperts@debtreliefoptions.co

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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