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As a mother/business owner/wife(of a trade business owner)/woman, Amber Conley knows the challenges and frustrations of trying to b

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

alance a simple 24 hour day. “I sometimes find myself daydreaming of a life where everything is broken into time segments. Where e

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

Examples of combination products may in

very responsibility has a time slot and nothing else intrudes on that.” She says of her days.

But we all know life is not that sim

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. So how does she balance everything? “Very Carefully” She responds with a laugh.

She does it with a smile and a mind set of go

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

od enough is perfect, instead of perfect is good enough. Here are some of things she does to help her through her hectic days.

1.

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

Combination pro

Prioritize the things that matter most.

If you put off the things that you truly care about, no matter how much you get done, at

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

the end of the day you still feel like something was left out. Being able to spend time with your husband and children is the upsi

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

e to a stay at home mom. You might find that by doing this, too, you actually get more done because the family is less demanding w

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

hen you do need to concentrate on your business.

2. Structure your days, but be careful not to count the minutes.

It is very impo

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

tant to keep business hours, but you were attracted to this venture because it allows you to earn money and take care of your famil

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

y at the same time. So give yourself a realistic and flexible schedule.

3. Don’t make a list of 5, 10 or 20 things to do.

Do mak

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

Following aspects would a

e a list of things that need to get done that day, but the trick is, don’t review it at the end of the day. Simply sit down, write

dd to the challenges in developing combination products:

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

a list of everything you did accomplish and then the next day write your to do list again. This shows you how much you are accompl

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

ishing which is probably more than you are giving yourself credit for.

4. When you go to the bathroom, or you are doing the dishes

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

let hot water run over your hands for as long as you want.

“This is my personal favorite.” It is so relaxing, and this ten secon

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

d break becomes a huge boost to your energy. It is so simple to find little things like this to spoil yourself through out the day

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

Professional from academic institutions, pharmaceutical industries, health care indust

with out feeling like you are spending too much time on yourself.

5. Know that good enough is perfect.

“I wore my self into the g

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

round, literally, trying to be perfect, the perfect mom, the perfect wife, the perfect woman, the perfect business owner. Just rea

.

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

ing that is exhausting.” When you stand back and really examine how realistic those goals are, and how GOOD you are at your life,

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

Companies that provide selfless information through particip

you begin to feel good about yourself. And the better you feel, the better you will be able to accomplish what you need AND want to

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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