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What is Change? Several dictionary definitions are: to undergo transformation or transition, move from one phase to another, alter one’s approach or attitude, shift from one to another, or to become different.

When you hear those definitions, what thoughts

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

, questions or concerns does that bring up for you? For many of us, change is often seen as something we want but are somewhat afraid of. Why is this?

Why does Change bring up so many conflicting emotions?

Change takes us out of our Comfort Zones

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

Examples of combination products may in

. Our comfort zone is our cozy quilt of the routines we have that make us feel good. It’s the security of predictable behavior, experiences, people and places. Our comfort Zone keeps us in a familiar place and we feel safe. We’re pretty sure we can succe

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

ed, look good, feel good, and feel happy there, most of the time anyway. Outside our comfort zone…well who knows? Yes, safety and comfort are important, but when our comfort zone becomes a barrier, preventing us from changing our lives for the better, that

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

is when it is time to ask how willing we are to stretch. Why stretch? Because the Big Dreams and Goals we have for our lives always lies outside our comfort zone, if they didn’t, we would all have everything we wanted wouldn’t we?

What are your Big Dr

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

Combination pro

ams and Goals?

Change takes us into the Unknown. Part of the discomfort of change lies in the unknown of who we are, what we want to change, why we want it to change, how we will achieve it and how we will handle it. Yes, knowledge is important, for

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

if we don’t know where we are going we surely won’t get there. But, can we know everything about what is to come? Would we truly want to? Martin Luther King said “You don’t have to see the whole staircase, just take the first step in faith.” What if we w

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

ere to collect just enough information to help us make a choice, but not so much that keeps us from choosing?

How much do you need to know before you will be willing, ready and able to change?

Change brings up thoughts and fears. Most of us will pr

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

obably admit that often, when faced with change of any kind, our attention immediately moves to what we are not getting, won’t have any longer, are losing or leaving behind. We look for what may go wrong, worry about the risk and fear the unknown. William

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

James said ““Human beings, by changing the inner attitudes of their minds, can change the outer aspects of their lives.” Instead of our usual thoughts about change, what if we saw change as an opportunity for growth, a chance to expand our mind and spirit,

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

a way to experience amazing new possibilities? What would it be like if we put our attention on what we are seeking, what we are wanting to be different in our lives instead?

What do you currently believe about change?

What if you decided, chos

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

Following aspects would a

e, to believe something different?

What would you want to believe?

Change gives us the opportunity to live according to our Values. Change becomes easier when we follow and strive to live out our values – what we gravitate toward, what feels

dd to the challenges in developing combination products:

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

right and matters to us in life. Moving toward something that is meaningful to us with the express intention of living our values brings us not only joy, but makes change more exciting. For example, I highly value beauty in my physical environment. For

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

me that means lush plants and trees, sunshine, blue skies, a clean community that also values beauty of space. When we first arrived in North Carolina we found the embodiment of these values. So, despite the fear we had in changing our lives so drastically

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

, despite the risks, the new possibilities pulled us toward our new direction with excitement!

What do you Value in life?

Change means we have to Let Go. To fully commit to living our values and embracing change, to have it become a fulfilling grow

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

h experience, we must also be willing to let go of certain aspects of our lives. If I had left one foot in New York and one in North Carolina, I would have been neither here nor there, in a sort of limbo state, not fully committed to my choice. Certainly,

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

Professional from academic institutions, pharmaceutical industries, health care indust

depending upon the change you are seeking there are a variety of things you may have to let go of including people, experiences, possessions, habits, beliefs….

For example: If you are seeking to change your home environment to one that is clutter free, you

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

may want to let go of possessions that no longer serve a purpose in your life; if new friendships are what you are seeking, you may have to let go of the expectation of finding the exact same friends you had before; if a new career is the change you are seek

.

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

ing, maybe you have to let go of the emotion you are carrying about your previous one.

What are you willing to Let Go of to embrace change in your life?

So as we can see, there are many emotions that surround change, many reasons why we choose not

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

Companies that provide selfless information through particip

to do it. However, if we choose to undergo a transformation or transition in our lives, and we alter our approach or attitude toward it, change can be both exhilarating and very rewarding! Remember, “Our current safe boundaries were once unknown frontiers.

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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