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The interesting answer to that question is that it depends. The traditional sauna is elect

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

ric, wood or gas-fired. Some say that the presence of steam within a traditional sauna is

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

Examples of combination products may in

important to improving sinus and respiratory function. Others think that throwing water on

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

the heater is wrong. They say that the sauna is meant to be a dry heat.

In the real trad

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

tional sense the sauna is shared by the community and in most cases is located near an oce

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

Combination pro

an or lake. The traditional sauna is actually Finnish. The traditional sauna is a wooden e

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

nclosure and those using it would throw water on the stones, so even today as attitudes ch

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

ange towards what the correct sauna practice is, that does not mean that it has been that

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

ay from the beginning.

The traditional sauna preheats anywhere from 140 to 200 degrees Fa

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

hrenheit. This high heat is required for heavy sweating. Both the infrared sauna and the t

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

raditional sauna make you sweat. The heat in an infrared sauna is less than that of its tr

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

Following aspects would a

aditional counterpart.

I prefer the infrared sauna because the room is not as hot, yet I

dd to the challenges in developing combination products:

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

weat just as much. The air in the infrared sauna heats to between 110-120F. The intense he

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

at in traditional sauna can be too much for me. So yes I am a wimp when it comes to high h

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

eat. As long as I am sweating I feel I am getting the necessary detoxification and cleanse

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

that I seek from using a sauna.

To me which one is better is dependent on which one you

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

Professional from academic institutions, pharmaceutical industries, health care indust

re most comfortable in. Both have similar health benefits, such as increased blood circula

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

tion and so on. Like anything else there are arguments on both sides. If you want to put a

.

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

sauna in your home, infrared is the way to go because it is far less expensive in both in

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

Companies that provide selfless information through particip

stallation and running costs. Either way saunas are a great tool for health and relaxation

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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