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Summary - The Blueprint to Success? It Is Really an Easy Recipe!
Just like baking a cake, there is a recipe for success and it really is no more difficult than baking cake. All it takes are some very simple tiny steps.
1. Think about who you are or want to be and make a declaration: "I am the possibility of
1. Think about who you are or want to be and make a declaration: "I am the possibility of
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
being adventurous and charming.
2. Now that you have created a possibility for your life, stand in that possibility and think about what your life will look like three years from now. Think about what you will have or be doing. Standing in th
2. Now that you have created a possibility for your life, stand in that possibility and think about what your life will look like three years from now. Think about what you will have or be doing. Standing in th
; 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
e future as if it has already happened is the best way to create the next three years of your life.
3. Each quarter (every three months) create goals based on your 3-year vision. For each quarter, create your goals by standing in the future as
3. Each quarter (every three months) create goals based on your 3-year vision. For each quarter, create your goals by standing in the future as
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
if they have already happened.
Now, you might be asking, "Why do they keep telling me to stand in the future?" The reason why is that fantasy and reality are interpreted the same way by your subconscious. It's why you get scared when watching
Now, you might be asking, "Why do they keep telling me to stand in the future?" The reason why is that fantasy and reality are interpreted the same way by your subconscious. It's why you get scared when watching
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
a horror film. Similarly, if you lifted weights every single day for three years, would the weight that you are lifting today seem as heavy? This is a key ingredient to your recipe for success.
4. Much like a cook, you need a recipe to follow
4. Much like a cook, you need a recipe to follow
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
to bake the cake that you want because it prioritizes your actions. We'll call this recipe for success your Unleash Lifelog. One of the biggest and most frequently made mistakes is not writing things down. A good memory is a wonderful trait bu
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
t writing your goals down makes them much more likely to happen because they are now real with a physical form. The funny thing is that many people experience success after writing something, never reviewing it again only to find it years later
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
to realize that they accomplished everything on the list!
If you take nothing more away from this article, we really want you to get that your world is create by your words. For example, after Sputnik was launched, President Kennedy asked NAS
If you take nothing more away from this article, we really want you to get that your world is create by your words. For example, after Sputnik was launched, President Kennedy asked NAS
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
A how many years it would take to put a man on the moon. Even the most optimistic estimates told him that it would take at least 30 years. After hearing that, in a speech at Baylor University, he said, "By the end of this decade, we will have p
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
ut a man on the moon!"
Kennedy stood in the future and made it happen at least 20 years before even the most optimistic experts said it could be done... even though he would be assassinated six years before it was accomplished. The flipside of
Kennedy stood in the future and made it happen at least 20 years before even the most optimistic experts said it could be done... even though he would be assassinated six years before it was accomplished. The flipside of
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
this story is that had Kennedy not made that declaration, the experts' beliefs would have prevailed and set back the space program by at least 20 years.
While at the same time keeping you on track with the basics, this structure is key to the
While at the same time keeping you on track with the basics, this structure is key to the
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
recipe for success because it gives you the ability to create infinite intentions, possibilities and goals.
It's that simple!It's that easy! Now, you have already set your three year goals as well as goals for the next three months. But how to
It's that simple!It's that easy! Now, you have already set your three year goals as well as goals for the next three months. But how to
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
you guarantee that you accomplish those goals? Step by step, complete your weekly goals that you detail in your weekly Unleash Lifelog. It's like the old saying, "How do you eat an elephant? One bite at a time!"
To further guarantee your succ
To further guarantee your succ
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
ess and even go well beyond your goals, revisiting your current goals and three year goals will propel you even farther ahead.
Here's how you can revisit your quarterly goals:
Open your quarterly goals log and reread each of your minimum and
Here's how you can revisit your quarterly goals:
Open your quarterly goals log and reread each of your minimum and
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
targeted intentions and ponder each one.
If you accomplished it, congratulate yourself and place a check mark next to it.
If you are absolutely, positively, 100% sure you will complete it by the end of the quarter, write "OK" beside it.
If y
If you accomplished it, congratulate yourself and place a check mark next to it.
If you are absolutely, positively, 100% sure you will complete it by the end of the quarter, write "OK" beside it.
If y
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
ou are no longer committed to completing it because you no longer care about it or there is less than a 10% chance that you will complete it, do yourself a favor and either delete it (or put a big "X" through it) or revise it so you can absolut
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
ely complete it before the end of the quarter.
A lot of people believe that this is giving up or cheating but it is not. It is simply acknowledging where you are at and what you are really up to. If you are so far behind that you absolutely ca
A lot of people believe that this is giving up or cheating but it is not. It is simply acknowledging where you are at and what you are really up to. If you are so far behind that you absolutely ca
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
nnot meet your goals then probably wouldn't have met them anyway. So, why beat yourself up? Don't stress out over something that is impossible to accomplish. Simply recreate your goals so that you can accomplish them.
Remember: there is no pen
Remember: there is no pen
.
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
alty for setting modest goals and overachieving. You won't feel bad about that! However, if you set a high goal and don't achieve, you'll probably feel like a failure right? Let's look at one example: you set a goal of losing 20 pounds in 60 da
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
ys but you discover that it is only healthy to lose a pound a week and you lost 5 pounds in thirty days. Would it be healthy to push to lose another 15 pounds in 30 days? Of course not! Recommitting is not failing or cheating... it's just smart
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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