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Advice You - Your Picture of Success
I'm sure you've heard that the best way to achieve something is to have a clear understanding of your goal. The more detailed your picture or statement, the more likely you are to reach your de
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
sired milestone.
Most people want to succeed in a career that is more fulfilling and meaningful than what they have now. In addition they want to be happy and live a good life. Of course each
Most people want to succeed in a career that is more fulfilling and meaningful than what they have now. In addition they want to be happy and live a good life. Of course each
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
person has their own take on how they envision this goal.
What is it that you want in your life? How do you picture your success? Can you describe your personal definition of success?
As you
What is it that you want in your life? How do you picture your success? Can you describe your personal definition of success?
As you
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
think about your vision of success do you find any worries and concerns bubbling to the surface? It’s possible you have conflicting definitions of success simultaneously running around in your
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
mind. Your internal conflict creates confusion and turmoil as you try to make progress toward a goal that's at cross purposes with itself.
As a way to explore what’s happening within you, ask
As a way to explore what’s happening within you, ask
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
yourself the following four questions. As you answer the following questions, I encourage you to write down your answers so you can refer back to what you've written.
Four Questions about Succ
Four Questions about Succ
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
ess
1) From your perspective, what is society's picture of success?
2) What was your parent's definition of success for themselves? (You may have a different answer for your mother and father
1) From your perspective, what is society's picture of success?
2) What was your parent's definition of success for themselves? (You may have a different answer for your mother and father
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
so write down both.)
3) What was your parent's definition of success for you? (Again, the messages - stated or inferred - may be different for each parent.)
4) What's your definition of succ
3) What was your parent's definition of success for you? (Again, the messages - stated or inferred - may be different for each parent.)
4) What's your definition of succ
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ess for yourself?
Making Sense of Your Answers
After you've written down your answers to these questions, read your responses again. What do you notice?
Keeping your responses in mind, look
Making Sense of Your Answers
After you've written down your answers to these questions, read your responses again. What do you notice?
Keeping your responses in mind, look
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
at the questions below to understand what you are learning about yourself.
1) Is your definition of success the same as or different from:
-- Your parent's picture for your success?
-- Your
1) Is your definition of success the same as or different from:
-- Your parent's picture for your success?
-- Your
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
arent's sense of success for themselves?
-- Society's definition of success?
If it's the same, how does that sit with you? If it's different, how do you feel about that?
2) Think about your
-- Society's definition of success?
If it's the same, how does that sit with you? If it's different, how do you feel about that?
2) Think about your
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
life--how much do these other definitions of success impact how you think about your life and the actions you take in life?
-- Are you troubled or worried about not living up to someone else's
-- Are you troubled or worried about not living up to someone else's
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
definition of success?
-- Do you worry about what others think of your choices and decisions?
-- Do you feel supported by the other definitions of success?
-- Do you see elements of success
-- Do you worry about what others think of your choices and decisions?
-- Do you feel supported by the other definitions of success?
-- Do you see elements of success
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
within yourself that are in conflict?
3) Do you believe you deserve to reach and live your picture of success?
-- If not, what's standing in your way?
-- Is so, what's your next step?
If y
3) Do you believe you deserve to reach and live your picture of success?
-- If not, what's standing in your way?
-- Is so, what's your next step?
If y
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ou've been living under someone else's definition, how can you revise your own definition of success so that it more truly reflects who you are and what you stand for?
What to Do Next
There a
What to Do Next
There a
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
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
re numerous ways these messages weave their way into your thoughts and actions. Growing up in your parent's household meant that their messages surrounded you day in and day out for most of you
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
r youth. At first it's hard to see the impact these definitions have on you today, but once you start to see them, you begin to notice how they (or your rebellion to them) are entwined in your
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
thoughts, beliefs, and actions.
As you become more aware, consciously uproot the outdated ideas and nurture the ideas you want to live by. Over time as you peel away the old conflicting messag
As you become more aware, consciously uproot the outdated ideas and nurture the ideas you want to live by. Over time as you peel away the old conflicting messag
.
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
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
es you’ll have more energy to create the life you dream of.
Depending on your situation, you may not be able to turn this around in one sitting, but sometimes a very small insight can be the t
Depending on your situation, you may not be able to turn this around in one sitting, but sometimes a very small insight can be the t
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
hread that begins to unravel a puzzle that’s troubled you for a long time. Keep following the thread of insight to discover your new future.
Copyright 2006 Transition Dynamics Enterprises, Inc
Copyright 2006 Transition Dynamics Enterprises, Inc
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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