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Main Subject - Rising Above The Minutia
Is it menusha or minutia? However you spell it, the question remains: How do we avoid getting stuck in it? First let's get a handle on: Wh
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
at is it? From dictionary.com...
mi·nu·ti·a (n): A small or trivial details: From Late Latin mintiae, petty details, from Latin mintia, smallness, fro
mi·nu·ti·a (n): A small or trivial details: From Late Latin mintiae, petty details, from Latin mintia, smallness, fro
; 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
mintus, small.
So it means petty details. Let's define what it really means for many of us.
1. Metaphoric mud, quicksand or manure.
2. All of that se
So it means petty details. Let's define what it really means for many of us.
1. Metaphoric mud, quicksand or manure.
2. All of that se
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
mly urgent, somewhat routine, not that important stuff that needs doing. When we routinely do it, it keeps us from getting to the less urgent yet really
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
mportant stuff that would lead to greater progress and success if we could just get around to it.
3. Undesirable clutter
4. Stuff that hijacks your #1
3. Undesirable clutter
4. Stuff that hijacks your #1
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
To-Do List items
5. a less vulgar way to convey the s-word
Listen for the term. When you hear it, is it describing a scenario with an absence of focus
5. a less vulgar way to convey the s-word
Listen for the term. When you hear it, is it describing a scenario with an absence of focus
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
n what is genuinely important? Isn't the trivial outranking things of higher potential when allocating time and/or resources?
Mixing Economists and min
Mixing Economists and min
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
tia
Now here's a group we might associate with minutia; economists! They seem to enjoy using intellectual yet cluttered phrases like marginal propensit
Now here's a group we might associate with minutia; economists! They seem to enjoy using intellectual yet cluttered phrases like marginal propensit
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
to consume. Perhaps they might help us while here, let's create a new economists' buzz phrase. What if economists examined the opportunity cost of minut
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
ia where you work? Could they quantify the amount of major opportunities that are squandered because you're stuck in the daily minutia. What opportunit
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
es are currently on your agenda that were also there six to twelve months ago? What does delayed execution cost you each year?
Solution: Working Smart
Solution: Working Smart
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
r
Isn't 's this just another way to define the difference between working hard and working Smart? Working Smart is about avoiding, minimizing and overco
Isn't 's this just another way to define the difference between working hard and working Smart? Working Smart is about avoiding, minimizing and overco
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
ing minutia. It's about prioritized commitment to written goals and action plans for your most significant achievements. If we could just get ourselves
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
and co-workers to commit to the active pursuit of goal achievement, might you reduce our opportunity cost of minutia?
Authors notes:
With as many times
Authors notes:
With as many times
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
as I've used the word minutia on this page, this page will likely become prominent in Google and Yahoo for both menusha and minutia. If only minutia was
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
saleable e-commerce commodity! Perhaps not. But we do get paid for helping people to rise above their minutia.
If it's getting deep where you work and
If it's getting deep where you work and
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
ou're open to take action to avoid squandering opportunities, feel free to drop me a line.
Minutia Trivia: for the hopelessly mired.
* There is a Men
Minutia Trivia: for the hopelessly mired.
* There is a Men
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
asha, Wisconsin (that's Men-ASH-a).
* Menusha is a first name for some women of Japanese ancestry. For the sake of these women, let's hope it's also th
* Menusha is a first name for some women of Japanese ancestry. For the sake of these women, let's hope it's also th
.
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
name of a Japanese flower or fragrance.
* There's a Minutia Magazine. No Menusha! It's for micro and mini car enthusiasts.
* Minutia Trivia? How re
* There's a Minutia Magazine. No Menusha! It's for micro and mini car enthusiasts.
* Minutia Trivia? How re
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
undant is that?
* Enough! How is trivial minutia is holding you back? Before you go back to work: What might you start to do differently to overcome it
* Enough! How is trivial minutia is holding you back? Before you go back to work: What might you start to do differently to overcome it
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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