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ArticlePedia - Four Voices
The Bible tells us that we must be led by the Holy Spirit. Since there are always four voices
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
we hear speaking to us at any given time, we must learn to distinguish each one so that we are
; 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
able to do the right things.
1. The most obvious voice is our own and it speaks to us in a va
1. The most obvious voice is our own and it speaks to us in a va
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
iety of ways. It is always telling us what we want, what we think, and what we feel. The Bible
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
refers to our mind, will, and emotions as our "flesh nature."
2. Another voice that clamors f
2. Another voice that clamors f
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
r our attention is the voice of other people. They are usually telling us what they want, what
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
they think, and what they feel.
3. The third voice is the voice of the devil. He is very subt
3. The third voice is the voice of the devil. He is very subt
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
le and speaks to us through worldly ideas and viewpoints that he has injected into other peopl
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
.
4. The fourth voice is the voice of God and He speaks to us in our spirits. He does not spe
4. The fourth voice is the voice of God and He speaks to us in our spirits. He does not spe
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
k to us in our minds. Unfortunately, that's where most people spend most of their thought life
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
in their heads. Again, the Bible refers to this as "the mind of the flesh" (Romans 8:7, AMP).
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
These are the four voices that we constantly hear and which voice we obey is based on our abi
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
ity to discern. Obviously, we want to obey the voice of God if we are going to enjoy a success
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
ul life.
Most of us tend to live on the shallow surface where our physical senses, thoughts,
Most of us tend to live on the shallow surface where our physical senses, thoughts,
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
feelings, desires, and emotions are constantly being stimulated by worldly, carnal, fleshly wa
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
s. Because of this, we are not able to hear from God and be led by His Spirit, leaving ourselv
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
s wide open to fall for the many deceptions of the devil.
So, how do we hear from God and be
So, how do we hear from God and be
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ed by His Spirit? Well, that's next week's article. For now, just realize there are always thr
.
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
e very loud voices screaming for your attention and only one still, small voice, which is the
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
oly Spirit of God, wanting to lead you in the way you should go.
Copyright 2005 Daniel N Brow
Copyright 2005 Daniel N Brow
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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