E-Articles - Health and Fitness

When you started making better food and lifestyle choices, you had no idea that eating better was not just about food and the physical body. You had

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

no idea that food, along with other wise choices, had the power not only to transform your physical body, but it had the power to transform your emoti

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

Examples of combination products may in

onal and mental well-being also.

We are not just talking about food. We are talking about the gifts of a better life.

Now, after walking through tw

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

doors, to your utter amazement, a third door stands before you. You have walked through that first door to better physical health, fitness, and well

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

-being through making wiser daily food and lifestyle choices. You have walked through that second door to better mental and emotional health and well

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

Combination pro

-being. And now a third door stands before you.

As you slowly open it, you are surrounded by bright light which touches your very soul and fills you

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

up from the inside out. You are standing on the threshold of discovering the “why” part of you. You know what you are made of and who you are, and n

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

ow unfolding before you, are the most important questions of all: Why you are here? What is your passion? What is your mission? What is your higher

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

purpose? Are you on the right life path?

Is your life aligned with your heart and your intentions?

With your health and beauty, talents, and uniqu

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

ness, how can you make a difference in the lives of those people you touch?

No longer encumbered by compromised emotions, thoughts, and physical inca

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

pacities, you now have the energy, the desire, and ultimately the freedom to pursue these soul-searching questions and consciously create your ideal l

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

Following aspects would a

ife.

And, this, my friends, is what true health is all about—optimal physical, emotional, mental, and spiritual well-being so that you can consciousl

dd to the challenges in developing combination products:

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

create your ideal life. And it all starts with a conscious thought, a conscious choice, and a commitment to you.

Allow me to share this quote with

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

you by Goethe:

“Until one is committed there is hesitancy, the chance to draw back, always ineffectiveness.

“Concerning all acts of initiative and c

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

reation there is one elementary truth, the ignorance of which kills countless ideas and splendid plans: that the moment one definitely commits oneself

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

then providence moves too.

“All sorts of things occur to help one that would otherwise never have occurred. A whole stream of events issues from th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e decision, reining in one’s favor all manner of unforeseen incidents and meetings and material assistance, which no man could have dreamt would have

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

come his way.

“Are you in earnest? Seize this very minute. Whatever you can do, or dream you can…begin it. Boldness has genius, power, and magic i

.

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

it. Only engage and then the mind grows heated; Begin and then the work will be complete.”

By Goethe

Are you committed to your body, your health

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

Companies that provide selfless information through particip

and your life? Are you in earnest? Then seize this very minute and grab on tight.

It’s time, right now, to take that first step to a whole new you

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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E-Articles - Doors of Awareness to Optimal Health and Fitness(Part 2 of 2)

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