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ArticlePedia - Say Something Useful When You Talk To Yourself
What do you tell yourself when you run into a problem? Do you think about how to fix whatever is wrong, or do you
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
get stuck?
The story you tell yourself about who you are in the world has an enormous influence on how you approa
The story you tell yourself about who you are in the world has an enormous influence on how you approa
; 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
ch problems. There are lots of different popular story themes that lead to different actions.
"I'm a competent pe
"I'm a competent pe
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
son." You notice the resources you have available - money, friends, time, transportation, etc., and start using th
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
em to find a solution.
"I never do anything right." You notice all your mistakes, criticize yourself for having t
"I never do anything right." You notice all your mistakes, criticize yourself for having t
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e problem, wait around hoping someone else will fix the problem, and put off any action. You may do something to h
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
elp you forget the problem like take a nap or read your junk mail.
"It's not my fault." You notice everything tha
"It's not my fault." You notice everything tha
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
others do wrong and spend a lot of time and energy telling them about it. You are angry that they don't take your
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
advice, and complain to your friends about how incompetent people are.
"If I want something done right, I have t
"If I want something done right, I have t
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
do it myself." You stay on top of all the details and make sure everything is done correctly. You are super respo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nsible, over committed and exhausted.
"I live in a wonderfully exciting world." You see problems as challenging o
"I live in a wonderfully exciting world." You see problems as challenging o
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
pportunities. You explore creative solutions, and if they do not work out, you try new ones.
The stories you tell
The stories you tell
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
yourself are like old habits. They are familiar and comfortable. If you change your story, you will start to notic
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
e different things about the world, and these will lead you to take different actions.
If you are living a story
If you are living a story
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
ou do not like, choose a new one to try on and play with. It's a little like buying a new outfit. Spend a few minu
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
tes every day reminding yourself about your new story.
Draw a picture that represents your old story. Then draw a
Draw a picture that represents your old story. Then draw a
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
picture that is the essence of your new story. Explain the differences to a friend.
Write out your new story. Pas
Write out your new story. Pas
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
te it on your bathroom mirror, your refrigerator, your desk, or the steering wheel of your car. Read it each time
.
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
ou see it.
Every time you are reminded of the new story do something - hum a few bars of a song, make a phone cal
Every time you are reminded of the new story do something - hum a few bars of a song, make a phone cal
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
l, or recall something you enjoyed - to make the new story come true. The more you practice, the easier it will be
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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