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I am astonished at the many people who have not achieved their aims because they simply did not ask how it is done. Think of all the missed opportunities, frustration pain, and yes, even suffering people

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

endure because they are not willing, or do not know how or whom to ask. This article will help you ask for anything.

First, let's look at some of the reasons people don't ask for what they want. I believe

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

Examples of combination products may in

the primary reason people don't ask for what they want is plain old-fashioned ignorance. I don' mean to be offensive, but ignorance in that they just don't know. Either they don't know what is available

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

to them because they have never been exposed to it, or they are so out of touch with themselves that they no longer can tell their real needs and wants. Another way ignorance come into play is that many ti

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

mes people just don't know who to ask, when to ask or how to ask. This may sound simple, but when you find yourself in a new situation, or new dilemma you often don't know which way to turn.

A second hind

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

Combination pro

rance to asking for what you want is the notion that we should not need to ask. Unfortunately, may people were raised to believe there is something wrong with asking. Some even see asking as a form of weak

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

ness or admission of failure. They couldn't be farther from the truth.

Third, many of us do not ask for what we want because of fear of rejection or embarrassment. Sometimes such fears are based on hurtfu

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

l incidents form the past, especially during the childhood years. Sadly, to avoid rejection and embarrassment many of us settle for a lifetime of underachievement based on these unfounded fears.

A fourth

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

consideration in not asking for what you want is that all too familiar low self-esteem. I have found that many, if not most of us feel unworthy or inadequate to create the kind of life we want. As a resul

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

t, we convince ourselves that our needs and wants are not worth pursuing - so we don't ask.

The fifth reason I believe we don't ask for what we want is pride. Many of us are convinced we need to do everyt

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

ing for ourselves and fear we will look foolish or lose respect among our family and peers if we admit the need for assistance.

None of these situations should keep you from getting what you want and need

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

Following aspects would a

out of live. You must take control of your life by asking for what you want and need. You must begin to believe you can accomplish anything your heart desires. You need to unlearn some tired old unproduct

dd to the challenges in developing combination products:

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

ive beliefs beginning with the five listed above. You can learn to overcome these hindrances and ask for anything you want by:

- Getting rid of ignorance. Start asking questions now about anything you don

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

't understand. Ask people how and why they do what they do and ask them why they do it? The difference between success and failure is often as simple as asking how.

- Don't worry about what other people t

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

hink, do or say. Always ask the questions you need answers for. Remember, you will not receive what you don's seek after.

- Accept rejection as a part of life. Rejection is a part of human existence, acce

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

pt it and live with it by not taking it personally. Keep asking and in time someone will answer. Don't give up because you feeling get hurt. Keep moving and asking.

- Don't wait until you have reached som

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

Professional from academic institutions, pharmaceutical industries, health care indust

e imagined degree of perfection before you ask for help or information. Your self-worth must be based on what you know about yourself, not what other think about you. Ask for what you need or want no matte

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

r what others may think of you.

- Put your pride in check. Pride goes before the fall. In other words, don't fail to succeed because pride caused you to act out of ignorance instead of knowledge. Ask the

.

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

questions you need to ask and ask them of whom you need to ask. Pride will not get it done. Asking the right questions of the right person will make all the difference in the world for you.

Now you are re

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

Companies that provide selfless information through particip

ady to find the answers to whatever questions you have been pondering. Read this article again and print it out. Take it with you if necessary, but do, right now, today - begin to ask for anything you want

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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