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Main Subject - The Source of All Ethical Values
To say that we as human beings have ethical values implies something quite profound. It literally means that we are, in a manner of speaking "hardwired" with such values. If we were not we would not ha
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
ve the ability to ever gauge when something was "right" or "wrong".
You see, before you can make such an assessment you need to have an "internal measuring stick" by which to make such measurements.
You see, before you can make such an assessment you need to have an "internal measuring stick" by which to make such measurements.
; 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
o where does this internal reference or "measuring stick" live inside of us? Well many would say that it is something we learn through our lives say from our families, religion, courses on ethics, invo
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
lvement with or awareness of the legal system and so on. In other words that the "ethical measuring stick" is just a set of rules we have acquired and is represented by the many beliefs we have about w
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
at is considered "good behavior".
If this were the case then that ethical measuring stick would be quite vulnerable to being altered the next time some new rule was espoused by some "authority". In ot
If this were the case then that ethical measuring stick would be quite vulnerable to being altered the next time some new rule was espoused by some "authority". In ot
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
her words the whole foundation of what is or is not ethical would be again on very shaky ground. This of course might also bring into question the reason we have ethical values at all as they would hav
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
no place from which to originally germinate.
Now if you consider for a moment a situation that you would consider transcends your ethical values notice where within you you make such an assessment. I
Now if you consider for a moment a situation that you would consider transcends your ethical values notice where within you you make such an assessment. I
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
f you notice it closely I think you will ultimately agree that apart from any beliefs you may have about the matter deeper down inside you also have some feelings about it.
For a moment notice these f
For a moment notice these f
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
elings. Notice where you feel them most intensely as you consider the situation that I asked you to focus on. Now do you "think" that these feelings were generated by you or did they just happen to eme
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
rge spontaneously without you having to do anything other than hold the situation in mind?
The next time you return to "thinking" about the situation at hand do you think that these feelings will "fee
The next time you return to "thinking" about the situation at hand do you think that these feelings will "fee
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
" any different? Likely not because the situation is what it is and you being human will "always" feel the way you do about it and nothing can change that.
So here we've come to an awareness of someth
So here we've come to an awareness of someth
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
ng inside you that appears immutable i.e. your feelings about the situation at hand.
Unlike one's beliefs these are unchanging and hence hardwired in each human being. Isn't this what we have been cal
Unlike one's beliefs these are unchanging and hence hardwired in each human being. Isn't this what we have been cal
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
ling the "internal ethical measuring stick", that which we rely on to guide us to the ethical high ground.
So if we all have this ethical hardwiring then why is it that we have any ethical problems to
So if we all have this ethical hardwiring then why is it that we have any ethical problems to
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
deal with at all on this planet? Shouldn't we all automatically be in alignment with them and living the good ethical life? Well if you look around it's clear that this is not the case so something mus
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
t be seriously wrong.
What do you know is this problem here? Well when you look at what we rely on to guide us in life it has very little to do with this internal wisdom. Feelings in fact have been ma
What do you know is this problem here? Well when you look at what we rely on to guide us in life it has very little to do with this internal wisdom. Feelings in fact have been ma
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
igned for too long and the "mind” and what we have chosen to "store" there through learning has attained predominant mastery over our lives. How does that feel to you?
The whole idea of ethics is supp
The whole idea of ethics is supp
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
osed to be about what is right and what is wrong, but for whom? Well for you! In other words this inner wisdom is the repository of information and guidance about what is right for you. That is what wi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
l lead you to a happy, successful, fulfilling life. What are the consequences to you of discarding or even denying this inner wisdom?
Well it means that you will feel lost, alone, confused, vulnerable
Well it means that you will feel lost, alone, confused, vulnerable
.
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
to being manipulated and exploited, and therefore unhappy and unfulfilled. In other words your life and your success will be stolen from you.
If all that education of yours has left you feeling this
If all that education of yours has left you feeling this
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
ay and you would like to find your way back to some clarity then kindly visit the web link below where you can download a free audio from me with a special message that will permanently alter your life
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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