Your Space - Health and Fitness

Many people snore every night and don’t give a second thought to the whys or hows. Many scientis

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

ts believe that snoring is possible partly thanks to gravity, and if this were true a lowered sta

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

Examples of combination products may in

e of gravity would mean it is impossible to snore. Do astronauts snore? This question has been

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

iscussed since mankind has pushed into the final frontier. Luckily we have had many opportunitie

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

s to test out this theory.

Upon the completion of two studies on space sleep and snoring, both s

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

Combination pro

owed that five astronauts completely stopped snoring while in space. In addition to that, severa

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

astronauts who suffered from sleep apnea (a condition in which a person stops breathing momentar

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

ily in their sleep) were cured of all symptoms while in space. Many scientists thought that they

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

had the answer to their question and without a certain amount of gravity snoring is highly unlike

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

y.

In 1998 another sleep study was done aboard the shuttle Columbia. Scientists wanted to see h

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

w an artificial environment would affect how the astronauts slept and their breathing. The resul

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

Following aspects would a

t? The astronauts snored and in addition actually breathed less, prompting many to think that br

dd to the challenges in developing combination products:

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

athing is more difficult in space. However, there are many factors that can contribute to a pers

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

n snoring, such as high weight, large neck size, and alcohol consumption. Typically these traits

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

are not typical of the physically fit astronaut. It is also possible that motion sickness plays

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

a part in snoring which has nothing to do with gravity.

Unfortunately there is no conclusive res

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

Professional from academic institutions, pharmaceutical industries, health care indust

arch that can determine whether or not all astronauts snore and under what conditions. Many scie

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

ntists are in disagreement over the research collected but almost all can agree there isn’t enoug

.

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

to make any definite conclusions. There are many correlations between snoring and gravity, but

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

Companies that provide selfless information through particip

here are so many extenuating circumstances this question may be unanswered for many years to come

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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