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Delicious - Impossible to Himpossible
"If we are thrown into the blazing furnace, the God we serve is able to save us from it...But if he does
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
n't..." (Daniel 3:17-18).
This is one of the most wonderful stories in the Bible of preservation! The th
This is one of the most wonderful stories in the Bible of preservation! The th
; 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
ee Hebrews were thrown into the fire because they would not worship a heathen god. The king was astonishe
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
d that first, the three men were not burned and second, that there was a fourth man in the fire with them
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
The fire had been heated purposely to destroy these men, so it was even more a miracle that they were pr
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
served.
But the wonderful lesson is that God was right there with them. He is with us in our trials, too
But the wonderful lesson is that God was right there with them. He is with us in our trials, too
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
. He does not prevent sorrow, for we all have them, but He is with us when they do happen. He doesn't jus
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
send help but He comes Himself. He is afflicted in our afflictions (Isaiah 53:9, one of my favorite chap
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ters as well as verses); He bore our griefs (Isaiah 53:4 and Matthew 8:17). Many times I pictured the For
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
of the Fourth on days that I thought I couldn't stand the pain of my son’s death another minute, much le
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s another day and month and year! I pictured Him as keeping the flames away, lifting me above them and fi
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
nally out of them.
Our loving God has given us so many instances of deliverance from pain, either of the
Our loving God has given us so many instances of deliverance from pain, either of the
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
heart or of the body, that we cannot doubt His love to us. And we finally find out, after we have endured
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
, that there are many fruits of our affliction that at the time we thought impossible. But all becomes HI
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
possible as we kneel beside our suffering Savior in the Garden of Gethsemane.
===
He leads us on by pa
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
hs we did not know;
Upward He leads us, though our steps be slow,
Though oft we faint and falte
Upward He leads us, though our steps be slow,
Though oft we faint and falte
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
r on the way,
Though storms and darkness oft obscure the day;
Yet when the clouds are gone,
Though storms and darkness oft obscure the day;
Yet when the clouds are gone,
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
We know He leads us on.
He leads us on through all the unquiet years;
Past all our dreamland h
He leads us on through all the unquiet years;
Past all our dreamland h
.
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
opes, and doubts and fears,
He guides our steps, through all the tangled maze
Of losses, sorrow
He guides our steps, through all the tangled maze
Of losses, sorrow
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
, and o'erclouded days;
We know His will is done;
And still He leads us on.
N.L. Zinzendor
We know His will is done;
And still He leads us on.
N.L. Zinzendor
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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