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The sun is a very powerful source of energy which powers natural cycles on earth like wind, water flow and plant growth.. Solar power is the technology of

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

obtaining energy from the sun. There are three approaches to gain maximum benefit of solar energy in our buildings.

Passive Solar

Passive solar

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

Examples of combination products may in

echnologies convert sunlight into usable heat without the assistance of other energy sources. Passive solar architecture is a design approach which seeks

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

to:

- maximise solar gains in the building (through orientation such as a south-facing site, layout, glazing etc)
- avoid the loss of heat from the

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

uilding through high quality insulation
- ensure a high degree of comfort by using controlled ventilation and daylighting

Passive solar systems hav

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

Combination pro

e little to no operating costs, often have low maintenance costs, and emit no greenhouse gases in operation. Passive solar principles can help reduce heat

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

ng requirements of a home by up to 80%.

The Passive House Standard can be found at www.passive.de

Active Solar Heating

Active Solar technologies

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

are employed to convert solar energy into usable heat, cause air movement for ventilation or cooking or store heat for future use. Unlike Passive Solar,

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

ctive Solar uses electrical or mechanical equipment such as pumps and fans to increase the usable heat. The most common use of active solar in Europe is 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

olar water heating. It is estimated that a correctly sized solar water heating system can provide for up to 60% of your water heating needs. Indeed, studi

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

s have shown that one square metre on your roof receives the equivalent of more than 100 litres of oil in free solar energy per year. Solar panels, genera

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

Following aspects would a

ly located on a south-facing roof, transform solar radiation into heat which is stored in a large hot water cylinder for whenever you need it.

Solar P

dd to the challenges in developing combination products:

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

hotovoltaic (PV) System Photovoltaics, or PV for short, is a solar power technology that uses solar cells or solar photovoltaic arrays to convert ene

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

gy from the sun into electricity. Solar cells produce direct current electricity from the sun’s rays, which can be used to recharge a battery or to power

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

equipment. When more power is required than a single cell can deliver, cells are generally grouped together to form “PV modules”, or solar panels, that ma

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

in turn be arranged in arrays.

Solar arrays are increasingly incorporated into new domestic and industrial buildings as a principal or ancillary source

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

Professional from academic institutions, pharmaceutical industries, health care indust

of electrical power. In a typical installation, an array is incorporated into the building (roof or walls). In this way, Solar PV can be used to provide f

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

ee solar electricity to houses. Recent developments in regulation mean that it will shortly be possible to connect solar PV systems to the grid, opening u

.

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

p a new era for solar PV in Ireland. Arrays can also be retro-fitted into existing buildings, normally by sitting them atop the existing roof. One new fea

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

Companies that provide selfless information through particip

ure of note came in August 2006 when Currys, the major high-street retailer decided to stock PV modules at a cost of a thousand pounds sterling per module

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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