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Digg It - Effortless Networking - In Only I Had The Confidence
If only I had the confidence...
... I would get over my fear of not wanting to waste other people's time, and ask t
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
hem for their help
... I'd speak in front of large groups of people and tell them what I do (because I love what I do!)
... I wo
... I'd speak in front of large groups of people and tell them what I do (because I love what I do!)
... I wo
; 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
uld confidently promote myself and my business
You can add to this list what you would do, if you only had
You can add to this list what you would do, if you only had
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
the confidence.
And if you've ever caught yourself saying something like this, here is my question for you: How do you
So unlike this woman, I often didn't speak up when this happened because I was sure that I was too afraid or nervous to speak cle
And if you've ever caught yourself saying something like this, here is my question for you: How do you
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
>know that you're "lacking confidence"? How did you come to this conclusion -- based on what?
Here's what I mean:
Here's what I mean:
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
At a conference I attended a while ago, the speaker at one of the sessions paused to see if the audience had any questions.
One w
One w
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
oman raised her hand. She started by saying that since her heart was thumping hard, it meant that she had something important to s
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
ay. So she'd better stand up and say it.
I was stunned.
I didn't hear much of what she said, because I was too busy processing t
I was stunned.
I didn't hear much of what she said, because I was too busy processing t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e implication of her opening remarks.
Here's what I was thinking:
All these years, when my heart started thumping durin
Here's what I was thinking:
All these years, when my heart started thumping durin
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
g similar situations, I had interpreted this as being a sign of nervousness, fear, anxiety -- in other words, lack of confidence.
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
So unlike this woman, I often didn't speak up when this happened because I was sure that I was too afraid or nervous to speak cle
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
arly.
And at those times when I did speak, I was so focused on my thumping heart and related discomfort, that I couldn't
And at those times when I did speak, I was so focused on my thumping heart and related discomfort, that I couldn't
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
pay much attention to what I was saying. As a result, I ended up doing exactly what I was afraid I'd do -- not speak clearly or co
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
herently.
So I concluded that I just didn't have the confidence to speak in front of large groups, or start conversations with pe
So I concluded that I just didn't have the confidence to speak in front of large groups, or start conversations with pe
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
ople I didn't know.
However, hearing this woman's comment I wondered:
However, hearing this woman's comment I wondered:
- What if my thumping heart is an indication some
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
thing else?
Have I been misinterpreting this as "lack of confidence" all these years?
Is it possibl
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
that I don't lack confidence after all, and have been holding myself back unnecessarily?
My point is this:
My point is this:
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
strong> very often our "lack of confidence" is a result of how we interpret a particular situation.
So gaining confidence then is
So gaining confidence then is
.
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
a matter of re-interpreting the same situation from a different perspective.
"No way! I think you're over-simplifying the matter
"No way! I think you're over-simplifying the matter
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
, Sri."
If that's what you're thinking, I dare you to try it out. You'll be amazed at the results you get (my clients always are)
If that's what you're thinking, I dare you to try it out. You'll be amazed at the results you get (my clients always are)
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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