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E-Articles - Every Problem Has A Solution, Are You Patient Enough To Find It?
How many times have you caught yourself saying that there could be no other solution to a problem - and that that problem leads to a dead end? How many times have you felt stumped knowing that the problem laying before you is
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
one you cannot solve. No leads. No options. No solutions.
Did it feel like you had exhausted all possible options and yet are still before the mountain – large, unconquerable, and impregnable? When encountering such enormou
Did it feel like you had exhausted all possible options and yet are still before the mountain – large, unconquerable, and impregnable? When encountering such enormou
; 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
s problems, you may feel like you're hammering against a steel mountain. The pressure of having to solve such a problem may be overwhelming.
But rejoice! There might be some hope yet!
With some creative problem-solving
But rejoice! There might be some hope yet!
With some creative problem-solving
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
techniques you may be able to look at your problem in a different light. And that light might just be the end of the tunnel that leads to possible solutions.
First of all, in the light of creative problem-solving, you must b
First of all, in the light of creative problem-solving, you must b
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e open-minded to the fact that there may be more than just one solution to the problem. And, you must be open to the fact that there may be solutions to problems you thought were unsolvable.
Now, with this optimistic mindset
Now, with this optimistic mindset
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
, we can try to be a little bit more creative in solving our problems.
Number one; maybe the reason we cannot solve our problems is that we have not really taken a hard look at what the problem is. Here, trying to understand
Number one; maybe the reason we cannot solve our problems is that we have not really taken a hard look at what the problem is. Here, trying to understand
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
ing the problem and having a concrete understanding of its workings is integral solving the problem. If you know how it works, what the problem is, then you have a better foundation towards solving the problem.
Not trying to
Not trying to
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
make the simple statement of what problem is. Try to identify the participating entities and what their relationships with one another are. Take note of the things you stand to gain any stand to lose from the current problem
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
. Now you have a simple statement of what the problem is.
Number two; try to take note of all of the constraints and assumptions you have the words of problem. Sometimes it is these assumptions that obstruct our view of poss
Number two; try to take note of all of the constraints and assumptions you have the words of problem. Sometimes it is these assumptions that obstruct our view of poss
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
ible solutions. You have to identify which assumptions are valid, in which assumptions need to be addressed.
Number three; try to solve the problem by parts. Solve it going from general view towards the more detailed parts o
Number three; try to solve the problem by parts. Solve it going from general view towards the more detailed parts o
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
f the problem. This is called the top-down approach. Write down the question, and then come up with a one-sentence solution to that from them. The solution should be a general statement of what will solve the problem. From he
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
re you can develop the solution further, and increase its complexity little by little.
Number four; although it helps to have critical thinking aboard as you solve a problem, you must also keep a creative, analytical voice a
Number four; although it helps to have critical thinking aboard as you solve a problem, you must also keep a creative, analytical voice a
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
t the back of your head. When someone comes up with a prospective solution, tried to think how you could make that solution work. Try to be creative. At the same time, look for chinks in the armor of that solution.
Number fi
Number fi
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
ve; it pays to remember that there may be more than just one solution being developed at one time. Try to keep track of all the solutions and their developments. Remember, there may be more than just one solution to the probl
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
em.
Number six; remember that old adage," two heads are better than one." That one is truer than it sounds. Always be open to new ideas. You can only benefit from listening to all the ideas each person has. This is especiall
Number six; remember that old adage," two heads are better than one." That one is truer than it sounds. Always be open to new ideas. You can only benefit from listening to all the ideas each person has. This is especiall
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
y true when the person you're talking to has had experience solving problems similar to yours.
You don't have to be a gung-ho, solo hero to solve the problem. If you can organize collective thought on the subject, it would b
You don't have to be a gung-ho, solo hero to solve the problem. If you can organize collective thought on the subject, it would b
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
e much better.
Number seven; be patient. As long as you persevere, there is always a chance that a solution will present itself. Remember that no one was able to create an invention the first time around.
Creative thinking
Number seven; be patient. As long as you persevere, there is always a chance that a solution will present itself. Remember that no one was able to create an invention the first time around.
Creative thinking
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
exercises can also help you in your quest be a more creative problems solver.
Here is one example.
Take a piece of paper and write any word that comes to mind at the center. Now look at that word then write the first tw
Here is one example.
Take a piece of paper and write any word that comes to mind at the center. Now look at that word then write the first tw
.
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
o words that come to your mind. This can go on until you can build a tree of related words. This helps you build analogical skills, and fortify your creative processes.
So, next time you see a problem you think you can not s
So, next time you see a problem you think you can not s
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
olve, think again. The solution might just be staring you right in the face. All it takes is just a little creative thinking, some planning, and a whole lot of work.
Until next time, keep reaching for your fullest potential!
Until next time, keep reaching for your fullest potential!
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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