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One of my hero’s, the late Norman Vincent Peale once said, “there is only one group of people that don’t ha

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

ve problems and they are all dead. Problems are a sign of life. So the more problems you have the more al

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

Examples of combination products may in

ive you are.” My addition to Norman’s quote would be, “if you don’t have any problems today maybe you are

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

on the way out of here and you don’t know it yet.”

This can be perceived as a tong-in-cheek philosophy 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

life, however it is closer to the truth than you might think. One thing you and I have both learned is tha

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

Combination pro

t everyone has problems. Some people have relationship problems, others have financial ones, some face ca

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

reer challenges, others struggle with health problems, some have social issues social, while others face di

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

fficult business challenges. No one is immune to adversity in life.

The key to success, happiness, peace

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

and life balance is to accept the - issues, negatives, problems, situations, challenges, struggles (I don’t

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

care what you call them) as a part of the life process of becoming, learning and growing. Failures, whine

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

s or victims see problems as life picking on them. Winners in life, regardless of their position, status,

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

Following aspects would a

age or circumstances see problems and adversity as a catalyst to becoming better, stronger, wiser, and more

dd to the challenges in developing combination products:

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

aware of the reality of their life.

Problems are not positive or negative they are neutral. They are eve

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

nts. It isn’t what is happening in your life that matters it is how you choose to see it and what you do wi

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

th it. Whether they are perceived as negative or positive is entirely up to you and your life outlook.

Lea

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

rn to see the negatives as loving teachers in your life bringing you the opportunity to get a clearer visio

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

Professional from academic institutions, pharmaceutical industries, health care indust

n of where you may need attitude adjustments, improved thinking or better skills. Why not make a list of a

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

ll of your problems and one by one ask yourself a few questions: Is there anything I can do about this - n

.

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

ow or later? Is it going to last forever? What would my hero, mentor or someone I respect do about this? Is

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

Companies that provide selfless information through particip

this a recurring situation in my life? Why? These should get you started. Add some of your own questions

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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Selling on eBay can be difficult if you don't know where to start. In the second of 12 articles, the niche selling area of children's books is exposed. This can be an extremely profitable area with a little research!

As the name suggests, this loan can be procured against a security. Apart from homeowners, even individuals with a bad credit score can apply for secured personal loans.

Managing your debts by yourself is much different than doing so when you have a family. When you are single, you only have to keep track of what you are spending. When you have a family, you have to not only manage what bills you are compiling but also keep track of what your spouse and possibly children are spending, or what is being spent on your children. A good budgeting system can help you deal with these situations.

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