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Suggest - Taking The Coach Approach
When you use what you go through to grow through, you take the coach approach. I am suggesting that you hire your own coun
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
sel. After all, who else knows your dreams, goals, and intentions better than you do? Who else has access to your inner com
; 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
pass?
Yes, you have an inner compass. And it guides you along the river of life. When we pay attention to our emotional r
Yes, you have an inner compass. And it guides you along the river of life. When we pay attention to our emotional r
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
esponses and our own ‘self’ talk, we are using our inner compass. It’s called living life from the inside out. It’s using o
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ur brain for a change. That’s right, use your own mind to create positive changes within you.
Both being aware of how we f
Both being aware of how we f
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
eel and listening to our self-talk serve a purpose. The inner compass provides us with a powerful feedback mechanism, simil
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
ar to a navigational system on an airplane. It lets us know whether or not we are on course, how far off course we are, and
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
how much correction we need to make in order to reach our intended destination (and to achieve our goals). Learning to use
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
these tools, we learn the art of coaching our self!
You may have heard the phrase, “It’s not that you got off track that m
You may have heard the phrase, “It’s not that you got off track that m
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
atters, it’s how fast (and gently) that you get back on track.” So, when it comes to your goals and intentions, what is imp
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ortant is not whether you fall down, but what how you handle it when you do. Is your ‘Inner Coach’ doing its job well? Is
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
it helping you get back up again? Or is it beating you up for falling down to begin with?
Is your inner voice helping you
Is your inner voice helping you
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
to feel inspired and encouraged? After listening to it, do you feel like a winner? Does it emphasize your strong points whi
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
le gently and lovingly pointing out where you need to do some work? Are you learning anything from it? Train your ‘Inner Co
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
ch’ by telling it what you need in order to succeed! You are the foremost authority on yourself.
I’ve begun to dialogue wi
I’ve begun to dialogue wi
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
th my ‘Inner Coach’ more often and am getting great results. We do things together too. We took a walk yesterday and we pla
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
n to go to the gym later this week. We’re making fast friends and I am achieving intended outcomes in my life. You too, hav
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e an ‘Inner Coach’ ready and willing to guide you gently through life. Just imagine, your own personal coach...
If our sel
If our sel
.
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
f-talk was broadcast to the world through a loud speaker, we would ‘get it’. We would be able to hear for ourselves some of
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
the damage we do through our self-talk. Let’s tame our inner critic and form a healthy relationship with our ‘Inner Coach’
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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