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References - Forget Dreams...Have Visions!
Do you still keep that all important 'Inner Spark Alive'? ...even 15 yr
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
s later from college!
To me 4 steps lead to 'true arriving'. Our succe
To me 4 steps lead to 'true arriving'. Our succe
; 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
ss domain can be summarized in 4 simple steps.
Step#1 : Dream With Tot
Step#1 : Dream With Tot
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
lly Relaxed Freedom!
Though I said, forget Dreams what I meant is drea
Though I said, forget Dreams what I meant is drea
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
m with freedom in detail. Uninterrupted, free flowing and mentally 'liv
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ng it out'. Learn to dream this way!
Step#2 : Let Your Dreams Lead To
Step#2 : Let Your Dreams Lead To
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
Visions!
Yes! Clear cut visions where you see the complete road map. A
Yes! Clear cut visions where you see the complete road map. A
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
l vivid and clear. Hearing, seeing, feeling, tasting and smelling whole
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
picture exactly as you want it. This is what I call focused visions.
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
tep#3 : Let Your Visions Lead To A Physical Model!
Make a small model
Make a small model
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
of your vision...just the way an architect make miniature models of his
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
buildings.
Or make a 'printable' model on a piece of paper. Thorough
Or make a 'printable' model on a piece of paper. Thorough
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
nd clear. Include everything that you want in it.
Step#4 : Begin To Ma
Step#4 : Begin To Ma
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
nifest Your Miniature Model!
Ladies and gentlemen! Now you are on to i
Ladies and gentlemen! Now you are on to i
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
!
This is the area where you come across some practical problems. Keep
This is the area where you come across some practical problems. Keep
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
focused on your miniature model - Begin tackling the problems as and 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
en it arises. One by one.
Forget the word determination to release yo
Forget the word determination to release yo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
urself from self-defeating pressures!
Instead, just be 'willing to go
Instead, just be 'willing to go
.
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
hrough' what it takes it to be there. That is submit yourself completel
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
y to your vision.
End Result: Your success! Unadulterated pure success
End Result: Your success! Unadulterated pure success
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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