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Global warming is the next big impact that will bring about a change in the weat

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

her patterns. By definition, Global Warming is the increase in average temperatu

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

re that gradually warms the Earth’s atmosphere. It is a phenomenon, which has be

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

n on the rise but in the last century, the increase in the levels have been alar

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ming.

The average temperature of the atmosphere has risen by 0.74 - 0.18 °C dur

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ng the last century. According to the study by the Intergovernmental Panel on Cl

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

imate Change (IPCC), it is observed that the increase in global average temperat

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

ure has been caused due to an increase in greenhouse gas concentrations. This ha

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

led to an unprecedented warming of the Earth’s surface.

The other phenomena’s

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

responsible for global warming include volcanoes and solar variations. Base on s

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

me of the models by the IPCC, the prediction is that the global temperature is l

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ikely to rise by 1.1 to 6.4 °C between 1990 and 2100. This increase in temperatu

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

re will cause climatic changes and extreme weather conditions like rising sea le

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

el, change in the amount of precipitation, above average rainfall, melting of po

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

lar ice caps and glaciers, storms and hurricanes.

On the worse side, it will al

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

o affect yield of crops as well as plants and animals leading to extinction of d

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ifferent species. Global warming will increase the spread of diseases and there

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

will be droughts and flooding, coral reef bleaching, forest fires etc. Global wa

.

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

ming is no more a myth but a fast approaching reality, which in the long term wi

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ll bring the much feared ice age that will wipe out all living organism on Earth

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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