Advice You - Business

We are all creatures of habit, whether we like it or not. Even though our habits often keep us in our comfort zone instead o

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

f reaching our goals, habits per se are not necessarily bad. Without habits, we would have to make conscious decisions at ev

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

Examples of combination products may in

ry turn. Nothing would be automatic. We would have to think about everything from brushing our teeth and combing our hair t

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

o driving the car. Habits allow us to perform thousands of tasks and routines without causing a mental overload. The only 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

rtinent question regarding habits would be: Am I willing to develop good habits or am I content to develop or continue with

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

Combination pro

ad ones? We can make a habit our servant, or we can allow it to become our master.

The following writing I came across seve

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

ral years ago. I found it to be a very powerful reminder for us all as it pertains to the habits we each hold on to so closel

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

:

Habit
I am your constant companion.
I am your greatest helper or your heaviest burden.
I will pus

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

you onward or drag you down to failure.
I am completely at your command.
Half the things you do, you might just as

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

well turn over to me,
And I will be able to do them quickly and correctly.
I am easily managed; you must merely be

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

firm with me.
Show me exactly how you want something done,
And after a few lessons I will do it automatically.

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

Following aspects would a

I am the servant of all great men
And, alas, of all failures as well.
Those who are great, I have made great.

dd to the challenges in developing combination products:

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

Those who are failures, I have made failures.
I am not a machine,
though I work with all the precision of a machine

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

br> Plus the intelligence of a man.
You may run me for profit, or run me for ruin;
It makes no difference to me.
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
> Take me, train me, be firm with me
And I will put the world at your feet.
Be easy with me, and I will destroy yo
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

u.
Who am I?
I am HABIT! (Anonymous)

Developing good habits, in every area from diet to communication

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

Professional from academic institutions, pharmaceutical industries, health care indust

skills, can be viewed as a conscious effort to become consistent in our performance. This consistency manifests itself in tw

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

distinct ways. Good habits will be consistent with our governing values. Habits are patterns of behavior that involve thre

.

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

e components: Knowledge, Desire and Skill. Because these three components are learned rather than inherited,

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

Companies that provide selfless information through particip

ur habits are our second nature, not our first, thus they are not our current habit. We can make or break our habits!

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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Advice You - The Power of Habit

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