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Advice Pool - Are You Trapped In Manifestationland?
Are you Trapped in Manifestationland?
There is so much interest and romance around the art of "manifestation" that it's easy to believe so many peopl
There is so much interest and romance around the art of "manifestation" that it's easy to believe so many peopl
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
e are falling for it like a fly into a Venus Fly Trap.
People tend to fall in love so quickly with the word "manifestation" that they become trapped
People tend to fall in love so quickly with the word "manifestation" that they become trapped
; 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
nd fail to examine what it really means.
On a linguistic level the word "manifestation" is referred to as a nominalization. All that means is that an
On a linguistic level the word "manifestation" is referred to as a nominalization. All that means is that an
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
action word (a verb) is treated as if it is frozen in time to become a thing (a noun). While some people talk about manifestation as if it were a rea
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
"thing" I've never seen someone pushing a wheelbarrow filled with manifest ion.
Those who fall hardest for the romance of word "manifestation" get t
Those who fall hardest for the romance of word "manifestation" get t
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
apped in "Manifestationland" and proceed to affirm, visualize, ritualize and meditate upon what they want while leaving out one key ingredient: a real
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
stic plan to get it, in other words, WORK.
Yes, a few people have completely lacked plans and seemingly "manifested" things they wanted. Some will us
Yes, a few people have completely lacked plans and seemingly "manifested" things they wanted. Some will us
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
this as evidence that "Manifestation" works but they overlook that, as a rule, a good plan and some applied effort will work better.
For every succe
For every succe
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
sful "Manifestation" an idiot can find 1,000 successes of work and planning.
Do you think there is something one can learn from this?
How do you kno
Do you think there is something one can learn from this?
How do you kno
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
if you're stuck in Manifestationland?
1) Do you believe that belief alone is enough to attract what you want?
2) Do you study, pray, meditate and a
1) Do you believe that belief alone is enough to attract what you want?
2) Do you study, pray, meditate and a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
firm for your manifestation more than you work toward your goal?
3) Do you believe yourself to be always "on the verge of a breakthrough" but can't d
3) Do you believe yourself to be always "on the verge of a breakthrough" but can't d
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
scribe what kind of breakthrough that might be?
How to get out of Manifestationland.
1) Have a plan. What is your very next step that your physical
How to get out of Manifestationland.
1) Have a plan. What is your very next step that your physical
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
ody will do to get closer to what you want (to manifest)?
2) Polish the plan. What is the step after that?
3) .... and after that???
4) Write out a
2) Polish the plan. What is the step after that?
3) .... and after that???
4) Write out a
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
detailed step-by-step plan to get to your goal.
5) Make each step measurable and specific. Having "a beautiful car" is not specific and could leave y
5) Make each step measurable and specific. Having "a beautiful car" is not specific and could leave y
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
u with a clean 1969 WV Bug when what you really wanted was a red convertible.
6) Make certain each step is stated in the positive. Affirming "I relea
6) Make certain each step is stated in the positive. Affirming "I relea
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
e all negativity to money." is neither positive nor specific. "I will learn how to make $100 a month on Ebay." however is both positive and specific.
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
7) Make each step is something that is within your complete control. In other words affirming "I will get $1000 by Friday." may be positive and specif
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
c but if you don't have a way that is WITHIN YOUR CONTROL to get $1000 then you are hoping, wishing and relying on happenstance.
Are ALL of these st
Are ALL of these st
.
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
p within your control?
Conclusion. Don't get stranded in Manifestationland. To do that see to it that every visualization, affirmation, ritual and
Conclusion. Don't get stranded in Manifestationland. To do that see to it that every visualization, affirmation, ritual and
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
meditation to manifest something has 10 specific, measurable and positive actions toward your goal. As a result you'll get what you want a lot quicker
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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