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Digg It - Why I always Keep my Promises
Integrity is very important to me, and I try hard to 'do unto other
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 as I would wish them do unto me'. It hasn't always worked that w
; 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
y for me though.
There have been times in my previous career
There have been times in my previous career
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
- times that I can remember vividly even now - when promises were n
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ot kept, things were borrowed, never to be returned and where I was
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
not on the best end of wheeling and dealing that are part of
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
corporate politics.
For me, creating honourable relationship
For me, creating honourable relationship
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
s with my people has always been important. It is a two-way street
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
Once when my wife was very ill, my management team told me not to
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
come in, despite it being a very busy time. I told them, thank-you
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
and I would come and go, in the comfort that they thought enough 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
f me; of us; to tell me to do that.
I didn't need to ask, bu
I didn't need to ask, bu
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
what they said to me at that time came from an environment of fair
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, honesty and trust had grown over time. They knew that if it h
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
ad been them, I would have offered the same.
It was as if, a
It was as if, a
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
Steven Covey says, in 'The Seven Habits of Highly Effective Peo
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
le', I had enough credit in my 'emotional bank account' to tide
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
me over. I'd never realised that I had that credit, but looking b
.
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
ck, my standards and values were daily deposits. You get back what
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
you give out.
There's no better time to start than right now
There's no better time to start than right now
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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