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Your Space - Commit to Do!
How many times have you made an attempt to do something only to fail? Have you ever attempted to start a project,
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
quit smoking, or loose weight, only to wind up either worse off than when you originally began or with a half-comp
; 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
eted project?
What about that business you swore you would promote this year? That book you were going to write?
What about that business you swore you would promote this year? That book you were going to write?
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
id you get it done? After numerous attempts at initiating an activity do you conclude you just can't adequately mo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ivate yourself to accomplish the task? Do you allow ‘things’ to get in your way?
Perhaps the challenge is not tha
Perhaps the challenge is not tha
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
you haven't formally set your ultimate goal, but rather that you have decisively committed to failure. Think back
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
, did you say I am going to ‘try'? The word try in itself is the beginning of the end. ‘Try' is simply not as moti
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
ating as ‘DO'!
Webster's definition of try is 1 a : to examine or investigate judicially b (1) : to conduct the t
Webster's definition of try is 1 a : to examine or investigate judicially b (1) : to conduct the t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ial of (2) : to participate as counsel in the judicial examination of 2 a : to put to test or trial
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
k> -- often used with out 3 : to make an attempt at – It is clear that even Mr. Webster fundamentally realized tha
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
to try was a pledge ONLY to try.
When you try to accomplish something you often fail simply because you have rel
When you try to accomplish something you often fail simply because you have rel
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
eased yourself from the guilt of failure; you never said you were going to do, just that you would try. Therefore,
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
when you do fail you can say “been there, done that” without feeling like you failed. However, the reality is; you
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
did fail!
I have found that when I commit to DO, things get done! That one simple word purposely produces a minds
I have found that when I commit to DO, things get done! That one simple word purposely produces a minds
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
t for success! I recall when I began my business, 30+ years ago, I simply decided to DO! I didn't say, I am going
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
o TRY, I said I AM GOING TO…! No option for potential failure there.
Another effective illustration I recall is w
Another effective illustration I recall is w
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
hen I decided to stop smoking. I had TRIED several times before, but the day I said ‘I QUIT!’; that is the day I R
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ALLY did quit!
How do you purposely produce decisive success? Yes, do start with a clearly defined goal in mind.
How do you purposely produce decisive success? Yes, do start with a clearly defined goal in mind.
.
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, do successfully create a plan, write it down, and make it a reality. But most importantly decide ultimately to
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
succeed! Commit to DO!
To be truly successful and to remain committed to your ultimate goal, ‘Commit to DO’ today
To be truly successful and to remain committed to your ultimate goal, ‘Commit to DO’ today
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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