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If you’ve been so busy working in your business that you have forgotten about yourself, it’s time to stop and assess the

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

situation.

Taking care of your business includes taking care of you! Think about it, if you’re run down and exhausted h

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

Examples of combination products may in

w effective can you be?

It will require time to take care of yourself, I know – you don’t have any extra time. But it i

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

costing you time when you continue to push yourself and neglect your needs.

It’s the many small ways you neglect yourse

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

lf that when added up can become a really big weight on your shoulders. And if you live with that big weight for a long

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

Combination pro

eriod of time, you may start to feel the life draining out of you.

This is similar to continuing to try to cut down a tr

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

e with a dull saw versus taking time out to sharpen the saw (Stephen Covey’s 7th Habit of Highly Effective People) and th

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

ereby cutting down the tree faster and easier than using the dull saw.

We all seek a balanced life and the truth is that

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

some periods will require that you work more than other times. The one thing to commit to, even when you are busy, is to

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

taking care of you – the business owner. Without whom, there may be no business.

What can you do today, right now, to s

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

art taking care of yourself? Here are some ideas to get you going:

- Take small, frequent breaks throughout the day

-

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

Following aspects would a

Ask for help if you’re stuck (someone you know probably knows the answer)

- Outsource/Delegate more

- Take time to eat

dd to the challenges in developing combination products:

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

healthy breakfast and lunch

- Engage in some kind of physical activity on a regular basis

- Take at least one day, out

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

of a seven day week, to do nothing but fun stuff and recharge your batteries

So while it may seem simplistic to make som

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

e small changes, just because it is simple doesn’t mean it is easy. So is it worth the effort? Absolutely!

Think about

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

the price you, and your business, are paying by not taking care of yourself. And consider how much more profitable (and

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

Professional from academic institutions, pharmaceutical industries, health care indust

appy) you would be if you did take better care of yourself.

What difference would it make in your life and business if y

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

ou were to make some changes like the ones mentioned above? Why not try it for a month and find out? If it doesn’t work

.

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

you can always go back to your old ways.

Make a decision to take extremely good care of yourself. Knowing that when you

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

Companies that provide selfless information through particip

o, you will be a more effective and profitable business owner and hopefully have a lot more fun!

(c) Stephanie Ward, 200

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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