Your Space - Self Improvement

What’s in your heart? What’s really in your heart? Do you know? Have you thought about it lately?

So many of us live our day-to-day lives simply going through the mo

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

tions. We just go on doing the things we’ve always done. We talk to the same people about the same things, eat the same food at the same restaurants, watch the same TV programs

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

Examples of combination products may in

week after week and think the same thoughts we’ve always thought. We don’t take the time to explore our hearts and to decide if what we are doing, thinking and spending

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

our time on are the things we really, truly desire.

Take a moment and think about your day yesterday. Was it lived from your heart? Did you do things that had real “feelings”

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

attached to them? Did you get done the things that are meaningful to you - even one thing? Did you have an intimate conversation with someone you love? Did you make sure the p

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

Combination pro

ople you love felt loved? If you answer yes to any of these, you are on the right track! If you’re not sure, there’s an easy way to learn to live from your heart.

As

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

you get ready in the morning, whether it is in the shower, at your desk, in your kitchen, as you take your walk - ask yourself two simple questions:

1. WHAT is most important t

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

me today? And,
2. WHO is most important to me today?

As you ask yourself, make sure you’re not just reciting the answers - really FEEL the answers. Visualize them. Br

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

athe deeply as you think about them. You’ll notice a couple things… some of your answers will bring joy and a smile to your face, and others may bring a hollow pit to your stoma

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

ch and a sense of dread. When you recognize these feelings or others like them, you will know that you are “thinking” from your heart.

Now, take those things that present negat

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

ve feelings and DECIDE if in fact you have to deal with them at all. Some of them may be things that are important to other people, not you, and you may not agree with

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

Following aspects would a

hem. If you choose to deal with them because those people are important to you, then make an agreement with yourself to do them quickly and well and move on to something else.

dd to the challenges in developing combination products:

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

You will find that completing unpleasant yet necessary things quickly will “free you” to truly live and enjoy your life. In fact, it is likely that you will feel a sense of acco

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

plishment and freedom and feel better as you move on to the things that your heart really desires.

Take those important things that present positive, glowing, loving emotions an

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

dwell on them. Plan your day to include the people and things you love. Call your Mom or your sister, hug your friends and your kids, set aside time to exercise or meditate, v

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

olunteer your time to a neighbor or a committee, look into a vacation spot for the summer - then, write a list of “important things to do” and DO at least one of them – today!

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

Professional from academic institutions, pharmaceutical industries, health care indust

he steps are simple - Feel, Think, Plan, Take Action.

You’ll notice that some of your answers will change from day to day. Some will drop in from time to time, and others will

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

ppear once and never return to your list. That’s how you’ll know it’s working, it’s from your heart… Your list will evolve as will your life. You will feel happier, “l

.

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

ighter” and accomplished. And you will feel JOY.

Imagine if we all lived our lives from our heart, what a different world this might be. Imagine it to be full of adventure, fu

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

Companies that provide selfless information through particip

, laughter and joy. Imagine it to be full of peace, love, forgiveness and hope. A world of sharing, caring and giving - and mostly, a world full of heart.

Now, that’s Powerful

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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