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Your Space - 100% - I Did!
"To one he gave five talents. . .to another two talents, and to another one talent, each accord
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
ing to his ability" (Matthew 25:15).
If we who claim to be Christian would claim the dormant p
If we who claim to be Christian would claim the dormant p
; 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
ower sealed within us and exercise whatever talents and gifts God has graced us with and then u
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
se them for God and others, just think of the revolution that would take place on this earth! G
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
d never intended for any of us to be unsuccessful. In fact, He called us to be bright lights an
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
d preserving salt and people who serve.
Elbert Hubbard, a very successful man, described a suc
Elbert Hubbard, a very successful man, described a suc
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
cessful person as one who tries, not cries; who works, not dodges; who shoulders responsibiliti
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
s, not evades them; who gets under the burden instead of standing off, looking on, and giving a
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
dvice. Charles Kingsley said: "The men whom I have seen succeed best in life have always been c
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
heerful and hopeful men, who went about their business with a smile on their faces, and took th
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
changes and chances of this mortal life like men, facing rough and smooth alike as it came."
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
The following is a ladder of success:
0% -I won't;
10%-I can't;
20%-I don't know h
0% -I won't;
10%-I can't;
20%-I don't know h
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
ow;
30%-I wish I could;
40%-What is it?;
50%-I think I might;
60%-I mig
30%-I wish I could;
40%-What is it?;
50%-I think I might;
60%-I mig
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
ht;
70%-I think I can;
80%-I can;
90%-I will;
100%-I did.
Someone comm
70%-I think I can;
80%-I can;
90%-I will;
100%-I did.
Someone comm
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
nted that success is 10% inspiration and 90% perspiration. Together that gives us the 100% of "
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
I did." We moan that we have no talent and opportunities when it is perseverance and concentrat
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
ion we need.
"Use what talents you possess; the woods would be very silent if no birds sang th
"Use what talents you possess; the woods would be very silent if no birds sang th
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
re except those that sang best." Henry Van Dyke. The birds don't worry about which of them sing
.
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
s best, either; they just do what is natural for them. Instead of worrying about others' talent
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
s, let us thank God for our own and get on with using them, for what we don't use, we soon lose
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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