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E-Folder - Think Beyond What Common Sense Would Allow
Our strengths often become weaknesses because we rely on them too heavily, habitually doing what we do best instead of seeking the best things to do. Someo
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
ne said, “If your only tool is a hammer, you approach every problem as if it were a nail.” Put down your old, familiar tools for now, or else find a differ
; 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
ent way to use them. Doing the right things, even very imperfectly, can bring you a quantum leap. Doing the wrong things, even if you do them to perfection
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
, will never deliver your dreams.
Think Beyond What Common Sense Would Allow.
Webster describes common sense as “Ordinary good sense or sound practical j
Think Beyond What Common Sense Would Allow.
Webster describes common sense as “Ordinary good sense or sound practical j
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
udgment.”
“Ordinary,” according to the dictionary, means “customary, usual, regular, normal; familiar, unexceptional, common; relatively poor or inferior.
“Ordinary,” according to the dictionary, means “customary, usual, regular, normal; familiar, unexceptional, common; relatively poor or inferior.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
” Webster also describes common sense as “sound practical judgment.” The meaning of “practical” is “obtained through practice or action.” In other words, c
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
ommon sense is judgment based on past experience. When you boil it all down, common sense is just what it sounds like - it’s what people today commonly bel
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
ieve. And common sense is full of dumb, limiting ideas. It has always been that way. Common sense used to say the world is flat, people can’t fly, bleed pe
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ople if you want to heal them. The idea of a man on the moon was once pure science fiction, so was television and the idea of a heart transplant. Common se
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
nse lies to you. It focuses on the obstacles, reviews what you’ve done in the past, studies the normal achievement patterns of people in general, and tells
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
you what you can commonly expect to achieve. It’s a self-fulfilling prophecy. Rely too much on common sense, and you can expect to see common results.
Qu
Qu
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
antum Leaps require you to start thinking
about what you want, instead of what common sense
says is the reasonable thing for you to expect.
What would c
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
ommon sense say you can accomplish? What would be a “sensible” goal?
Uncommon sense says that you can accomplish astounding things. What would be a goal w
Uncommon sense says that you can accomplish astounding things. What would be a goal w
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
ell beyond the boundary of improbable...far beyond the obvious next logical step?
What would you go for if you knew your success were guaranteed?
What wo
What would you go for if you knew your success were guaranteed?
What wo
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
uld you do, how would you proceed, in terms of specific action steps?
Most people have the wiring in their brains messed up. They’ve decided to doubt the
Most people have the wiring in their brains messed up. They’ve decided to doubt the
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
wrong things, such as their potential, the availability of breakthrough opportunities, and their chances for making a quantum leap. For now, if you must do
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
ubt something, doubt your limits. While it’s true that you can’t make yourself believe in your ability to make the quantum leap, you definitely can act lik
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e you believe. You can go ahead and do what you would do if you had complete faith. You always choose how your going to act anyway. You decide how you’re g
.
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
oing to behave. You don’t have to eliminate doubt to disregard it for the time being. Let it lie there, without influence, while you produce a remarkable 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
et of results by acting as if your success is for certain. Instead of letting doubt decide what you will do, decide what you’re going to do with your doubt
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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