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One of the most serious environmental crises facing us today is global warming. It is the gradual increase of the earth and ocean temper

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

ature as a result of the build up of certain gases which trap heat in the atmosphere causing the earth to warm up. These heat-trapping g

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

Examples of combination products may in

ses are also called greenhouse gases.

Although carbon dioxide is said to be the cause of more than 60% of global warming, there are oth

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

r substances which cause global warming as well, including methane, chlorofluorocarbons, and nitrous oxides. Did you ever asked yoursel

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

why the earth is heating up? Some may say it is a natural phenomenon, others may claim that man made the changes. As a matter of fact,

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

Combination pro

natural causes and human activities are the factors which influence global warming.

Studies claim that billion years ago, long before m

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

n exists, there is already a warming of the planet. One of the natural cycles which believed to cause the rise of temperature is the sun

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

pots cycle. For instance, explosions of the sun’s surface produces heat which can hit the earth causing intense temperatures. Another na

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

ural factor believed to affect global climate is the earth orbit and tilt.

Any changes of the earth orbit can cause the planet to move

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

loser or farther from the sun. Therefore it is one of the culprits for global warming. Evidence proved that plate tectonics caused poles

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

to be isolated from warm ocean currents. Thus it can affect our climate. Furthermore, another natural factor for global warming is the r

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

Following aspects would a

elease of methane gas from wetlands and arctic tundra. One example of greenhouse gas involved in global warming is methane.

Although gr

dd to the challenges in developing combination products:

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

enhouse gases occur naturally to keep the Earth temperature stable to maintain life, human activities increase the concentration of thes

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

gases in the atmosphere. As concentration of greenhouse gases in the atmosphere increases, the atmosphere is capable of absorbing more

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

eat. As a result, the earth tends to warm up. In this case, man is believed to be a factor for global warming. The rise of Industrial R

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

volution dramatically increases the concentration of Carbon dioxide and other greenhouse gases in the atmosphere at rates much faster th

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

Professional from academic institutions, pharmaceutical industries, health care indust

n the earth can cycle them.

Transportations, factories, electricity from coal-fired power plants produce carbon dioxide and other heat-

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

rapping gas in the atmosphere. Cutting down trees is another significant source of greenhouse gases, because fewer trees mean less conv

.

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

rsion of carbon dioxide to oxygen. In addition, research shows that burning wood and fossil fuels such as gas, coal, and oil contributes

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

Companies that provide selfless information through particip

carbon dioxide; methane is released from livestock and coal production; and agricultural and industrial processes produces nitrous oxide

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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