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Just Answers - Midwest Heatwave; Holy Heat Batman!
Well the deadly heatwave that killed 145 Californians during a we
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
ek-long heat of 112-115 degrees has now moved into the Midwest.
; 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
he heat wave now threatens both human life and agriculture. The h
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
eat wave will continue across the country killing livestock, crop
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
and many people. Especially susceptible of course are the elderl
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
y.
While the United States has so far dodged the Hurricane Bulle
While the United States has so far dodged the Hurricane Bulle
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
in both June and July, the heat has taken many lives and appears
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
to wish to take many more. And as far as the 2006 Atlantic Tropi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
al Hurricane, well August will be a tricky month there as well.
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
The Midwest is expecting temperatures well above 100 degrees for
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
everal days and the East Coast over 100 degrees also. Plus hundre
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
temps will occur in all Northern States in the next few days. Th
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
e commodity traders are already speculating and driving up prices
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
on many agricultural commodities and farmers are hoping for the b
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
est, but preparing for the worst just in case.
All this wacky we
All this wacky we
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
ther is really starting to bother some people and with all the vi
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
olence in the Middle East in Lebanon, many Armageddon types are s
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
arting to speak up as well. What are they saying? They are tellin
.
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
g us these are all signs of things to come? Boy I hope not, but I
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
must say it is hotter than holy heck Robin. Consider this in 2006
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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