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Summary - Should I Stay Or Should I Go?
"Advice is what we ask for when we already know the
answer but wish we didn't." –Erica Jong
All relationships have their ups and downs, strengths and weak
All relationships have their ups and downs, strengths and weak
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
nesses. Nothing in life is perfect. But, we find
our place along the way by accepting the good with
the bad and dealing with the cards that are dealt us in
t
; 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
he best way we can.
We all know that no one is ever "always right" or "always wrong." We learn to compromise, we learn to say we're sorry, and we learn when
We all know that no one is ever "always right" or "always wrong." We learn to compromise, we learn to say we're sorry, and we learn when
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
o hold 'em and when to fold 'em.
We all make mistakes and hopefully we learn from them.
When you find yourself in a relationship with someone who is a real p
We all make mistakes and hopefully we learn from them.
When you find yourself in a relationship with someone who is a real p
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
artner; you work through all of the "stuff"
that happens along the way. You are a team with a mutual
commitment. Respect for each other and a common
directio
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
n will get you beyond the tough times.
Many couples start out this way but eventually find their lives going in different directions. They may lose the connec
Many couples start out this way but eventually find their lives going in different directions. They may lose the connec
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
ion
with one another and they can't seem to communicate
no matter how hard they try.
There are many times these downward phases can be overcome; typically w
There are many times these downward phases can be overcome; typically w
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
hen both people want to work it out.
And there are times that one partner grows distant from
the other and you find yourself in a one-way relationship.
When
When
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
one partner wants to work it out and the other
doesn't; you find yourself in an emotional quandary. When
you are doing everything to make it work and your
p
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
rtner is doing everything to tear it apart is the time you
begin to ask yourself some very difficult questions.
We aren't talking about the normal up and dow
We aren't talking about the normal up and dow
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ns here. We
are talking about an overwhelming feeling that your life as
you knew it with this person is slipping away and no matter
what you do the outcome
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
is painful.
If you are in a relationship and asking yourself if you should stay or go; the mere fact that you are asking this question is your answer.
Eve
If you are in a relationship and asking yourself if you should stay or go; the mere fact that you are asking this question is your answer.
Eve
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
yone's circumstances are different. But, if you find
yourself crying, feeling bad, and wondering if this is all
there is the majority of the time; then you ar
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 more
than likely in an unhealthy, unhappy relationship.
When was the last time you heard someone who was in a happy, loving relationship ask, "I wonder if
When was the last time you heard someone who was in a happy, loving relationship ask, "I wonder if
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
I should leave?"
Feeling bad most of the time is a wake-up call that something
is wrong.
Begin to trust that your feelings are warning signals to protect y
Begin to trust that your feelings are warning signals to protect y
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
u against pain.
If you are in an unhappy, unhealthy relationship desperately trying to work things out all by yourself; you are going down a dead-end street.
If you are in an unhappy, unhealthy relationship desperately trying to work things out all by yourself; you are going down a dead-end street.
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
If you are in a relationship struggling
with the normal ups and downs and you both want things
to work, by all means keep working at it; you'll be happy you
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
did.
You need to get very clear on what it is you want out of life.
If you are getting your needs met; great! If not, you need to tell yourself the truth abo
You need to get very clear on what it is you want out of life.
If you are getting your needs met; great! If not, you need to tell yourself the truth abo
.
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
t the kind of relationship you are in
and then make some hard decisions.
Life is simply too long to live in a miserable, unhealthy relationship.
Once you are
Life is simply too long to live in a miserable, unhealthy relationship.
Once you are
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
brutally honest with yourself about the reality
of your relationship is the time that you will be able to answer
the question, "Should I stay or should I go?
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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