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Are You a Winner? What does it take to be a winner? Winning is really nothing more than an attitude. How is it that, although you are doing the exact same things as the next guy, the end result

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

s are not the same?

Let’s examine what ingredients make up a winning attitude. Whether you need to win a crucial athletic feat, shed a destructive habit, or accomplish financial security, 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

won’t miss if the following elements are utilized:

1. One day at a time

Whatever your goal is, do not get overwhelmed with the enormity of the task. Decide right at the outset to set attainab

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

le short-term goals as you go along. What can you accomplish today towards your long-term vision? Every day that brings results is an affirmation that you will be able to do the same tomorrow,

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

and so on.

2. Stick-to-it-iveness

Keep on keeping on. Do not allow yourself to get discouraged and give up. You never know how close you are to the breakthrough. Your next move; the next day

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

Combination pro

may be the one that will transform your destiny.

3. The right tools

Do you have the right tools for the job? If you want to win Olympic gold, do you have all the athletic abilities and traini

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

ng necessary? Do you want to become a network marketing success? Then you need to do your due diligence in studying the best marketing strategies, getting niche products, and consistently apply

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

ing what you’ve learned. “Get rich quick” schemes come about only with hard work and consistent strategic effort!

4. Look forward; not back

The past is good only for learning what not to do,

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

or applying the techniques developed to bring about success. It is of paramount importance, however, not to dwell on past failures and mistakes. The moment is Now. Go forward toward your dream.

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

5. Forgiveness

What does forgiveness have to do with winning? Get rid of all the bad feelings you have against those who have hurt you – whether deliberately or not. Past hurts will hold you

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

back. Let go; move on and prove to yourself that you Can do it. Remember, though, you are proving Yourself; you’re doing it for You. Doing something in anger, resentment or retaliation of any

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

Following aspects would a

kind will block your creative juices from flowing and rob you of the joyful satisfaction that accompanies success.

6. Gratitude

Develop a habit of thankfulness. Show gratitude to those who he

dd to the challenges in developing combination products:

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

lp you along the way. Take a few moments every now and then to reflect on all the good things you have, i.e. family, friends, education, affirming individuals, talents, etc. The bible states: “

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

whatsoever things are true, .. honest, pure, lovely, and of good report... think on these things.” (Phil. 4:8)

7. Inspiration

Have a daily quiet time with God. The Lord says that if we deligh

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

t ourselves in Him, He will give us the desires of our heart (psalm 37:4). The more you are attuned to Him, the more you will hear His voice and His leading in your everyday life. Whenever you

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

get to a point where you think you cannot do it or go any further, remember and recite out loud this encouraging verse: “I can do all things through Christ who strengthens me.” (Phil. 4:13).

8

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

Professional from academic institutions, pharmaceutical industries, health care indust

. Expectancy

Once you have the vision as to which path to follow to success; then expect great results! Thank Him for your success – yes, before you can even see it. “Faith is the substance of

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

things hoped for, the evidence of things not seen.” (Heb. 11:1). As well, the Bible tells us to make all our requests known to God. If He gave you the vision, the talent and the drive to follo

.

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

w your dream, then He will see you through! Write down your vision, paste it on the wall in front of you, and speak it out loud every chance you get. Faith comes by hearing and hearing by the W

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

Companies that provide selfless information through particip

ord of God! (Rom. 10:17)

Now, go on, Just Do It! Prosper and Be in Health, even as your soul prospers. Yes, that’s also in the Bible. It’s God’s Will that you prosper in every way. (John 3:2)

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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