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ArticlePedia - Dark Cages
Acknowledgement of our need of God and reliance upon Him will not always rid us of life’s press
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
ures, will not always remove from us the difficult situations, the dark cage within which we so
; 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
metimes find ourselves trapped. We shall not always escape the pressures of life and the dark s
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tuations which they bring. But we can, with God, withstand them and find resources for enduring
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
them even when they, for the time being, do not let up.
If we, who are caged within some dark
If we, who are caged within some dark
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ess and are frantic with fear that our situation is hopeless, would only believe, we would know
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
that our heavenly Father is close by to still our fears and to strengthen us for the ordeal th
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
ough which we are passing. We would know that He is constantly saying to us: “Don’t be afraid;
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
just believe.”
But how workable is this formula for confident and victorious living in our dai
But how workable is this formula for confident and victorious living in our dai
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
y existence? As we journey along the way of the Cross, we cannot avoid the central fact of fait
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
h and trust and its confirmation in Christian experience. The central fact is Christ Jesus our
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
Lord. His event in history showed man his highest possibilities. It pointed us to life’s deepes
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
and inexhaustible resources for living through and independent of any set of circumstances. It
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
provided us with a firm basis for the Christian belief that our sufferings, temptations, and p
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
rplexities, even the hard and oftentimes sudden demands of life, are fully understood and share
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
d by our Lord Jesus Christ.
Through Christ, we have access to an open door of grace and comfor
Through Christ, we have access to an open door of grace and comfor
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
and victory over life’s greatest, sometimes unyielding pressures. Freedom from the dark cage o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
f hard times may not happen as a result of our serious thinking or maneuvering, our hardest eff
.
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
rt or our best skill, but the key of divine grace and help remains within our reach. All we nee
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
d to do is pick it up, unlock the cage door, and walk out in the freedom of God’s amazing grace
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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