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Open up your favorite calendar and circle today's date.

Why? Because no matter what day it is, you've been given a

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

wonderful gift: a bright and shiny year ahead to make your writing dreams come true.

What are your writing goals

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

Examples of combination products may in

or the coming year? If you don't have any, this is the perfect time to create them. Clear goals help you stay focus

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

ed as a writer. If you choose what you want to accomplish, you can arrange your time and priorities to get them don

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

.

Take five minutes right now to decide what big things you'd like to achieve this year. (I'll focus on your writi

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

Combination pro

ng, but this technique can work for any area of your life.)

A long-established acronym, SMART, can help you create

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

great goals. SMART stands for

Specific
Measurable
Action-Oriented
Risk/Realistic
Timed

He

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

re's how each of these words can help you succeed.

Specific:

When determining your goals, be precise. Instead of

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

I'll write more this year," consider "I'll complete a new chapter every two weeks."

Measurable:

For each goal you

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

choose, make sure you can measure progress. For example, how will know you've completed it?

Action-oriented:

Cho

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

se goals you control so they're not at anyone else's mercy. Rather than "This year I'll get a book contract," set g

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

Following aspects would a

oals to complete and polish two novels or mail 30 queries to agents.

Risk/Realistic:

It's always good to stretch

dd to the challenges in developing combination products:

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

ourself. However, if writing ten pages usually takes you several weeks, don't count on writing six novels this year

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

. Unrealistic expectations can get you so frustrated you'll lose momentum. Instead, create goals that motivate you

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

ithout being burdens.

Timed:

Setting a particular deadline will help you pace yourself to get things done. For ea

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

ch of your goals, establish a completion date.

Next, take these big SMART goals and figure out what smaller steps

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou'll need to achieve each of them. Design these subgoals to be SMART too!

Once you have a list of goals for the y

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

ear, put them where you'll see them every day. Print them out and tape them to your computer, your office wall, eve

.

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

your bathroom mirror.

See them, know them...do them.

Writers, I hope this coming year brings everything you wish

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

Companies that provide selfless information through particip

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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