Advice Pool - Self Improvement

In January of this year, A-list celebrity Hillary Swank announced: “My New Year's resolution is to get rid of some stuff because I bring it in and I can't g

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

et rid of it.” If you were like Hillary Swank and you also placed organization on your list of New Year’s resolutions, then you were not alone. “To get orga

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

Examples of combination products may in

nized” was one of the top 10 New Year’s resolutions for 2007, according to about.com and myGoals.com.

While many individuals decided organization was a high

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

-ranking item on their ‘To Do’ list for the beginning of 2007, it may fall to the bottom of the list by the end of the year. Research illustrates that the p

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

ercentage of people who maintain New Year’s resolutions falls sharply as the weeks go by. After all, it is easy to set goals, but it does take a level of de

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

Combination pro

termination and dedication to see those goals to fruition.

If you decided in January that organization was a priority for this year and have since let your

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

objective slip, then it is time to re-energize your resolution decision. You have already taken the first and arguably biggest step of all because you recog

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

nize that you have a need for organization. There are a few more steps to the process, and they are equally as easy as the first.

Start now

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

, start somewhere! If you are still reading this article at this point, then you must have problems getting motivated to organize. Well, your

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

time has finally come! Not sure where to start? Pick the spot that annoys you the most. Want to finally park a car in the garage? Start there. Tired of

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

messy kitchen counters? Start there. If you still need some encouragement, picture how harmonious your life will be when your hard work is done.

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

Following aspects would a

Set general goals and specific sub-goals. Think of it as a puzzle - each smaller, specific sub-goal meshing together until a large

dd to the challenges in developing combination products:

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

r, general goal is completed. Finishing one small area will motivate you and propel you to the next! This eliminates the “I never can get organized!” feeli

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

ng because you are constantly accomplishing your goals, one step at a time. I believe Confucius said it best - “When it is obvious that the goals cannot be

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

reached, don't adjust the goals, adjust the action steps.”

Set a time limit. It is more likely that you will prioritize

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

with a looming deadline. Set long-term closing dates for general goals and short-term closing dates for specific sub-goals. If it helps, have a friend or

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

Professional from academic institutions, pharmaceutical industries, health care indust

a spouse hold you to your sub-goals. Then, reward yourself with something really enticing after each is achieved.

Now that January is far be

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

hind us, I wonder how Hillary Swank is doing with her organizing goals…is she super-dedicated and doing it herself, is she paying someone else to do it, or i

.

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

s she perhaps letting her resolution slide? I will probably never get an answer to my question, but Ms. Swank’s resolution does spur me on a bit. If a busy,

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

Companies that provide selfless information through particip

Oscar-winning actress can put some time aside to organize, then I can too!

© 2007 Clutterbugs, LLC - offering solutions for the organizationally challenged

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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We can't motivate people. They are already motivated. But we can determine what motivates them and use this knowledge to channel their energies toward our company goals.

On the Internet, it is very possible to make money without selling any product. One way of doing so is through starting your own eZine, also known as an electronic newsletter.

Most people will be familiar with insurance in some form or another. We all have taken out home insurance, car insurance or credit insurance among others. Insurance contracts are long and complex documents with a lot of small print.

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