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The Holiday Season. Does time seem to compress, or is it just me? There's so much going on

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

-- the end of autumn, the beginning of winter, and all the holidays that follow. As a child

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

Examples of combination products may in

it was an exciting time of year. As an adult, it seems filled with more shopping, baking, p

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

arties, and other events than I can squeeze into the available time.

In Aikido, the martia

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

art that I practice and teach, we have something called "randori," an exercise in which th

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

Combination pro

e student stands alone on the practice mat and as many as five opponents attack simultaneou

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

ly. Sometimes the holidays feel like this -- which task, event, or relationship do I take o

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

n first?

The first secret of randori is to handle one attack at a time. I can't let myself

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

become overwhelmed by the enormity of what's out there. I must stay fully present with what

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

's right in front of me. It's hard to do, but it saves time, energy, and wear and tear!

Se

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

ret #2 is to engage the attack. Though it sounds counterintuitive, welcoming the attack put

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

Following aspects would a

me in charge of it. I decide what I want to handle first and move toward it.

Planning a f

dd to the challenges in developing combination products:

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

amily dinner, finding places to stay for the relatives, shopping for holiday gifts, getting

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

the budget report done on time, AND hiring a new administrative assistant -- each task by i

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

tself might be doable, even enjoyable, but taken together they seem overwhelming. How to st

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

y balanced and effective?

In the midst of life's multiple, simultaneous events: Know tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

t each can be an attack or a gift -- it's up to you. Engage one task at a time. Every ti

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

e you experience the pressure of "How can I possibly do it all?" -- stop and BE where you a

.

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

re, and give your relaxed presence to the task at hand.

Gradually you'll feel in charge of

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

Companies that provide selfless information through particip

the only things you can be in charge of -- yourself and the present moment.

Happy Holidays

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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