Advice Pool - Health and Fitness

PDT or Photo Dynamic Therapy has existed for years, first with incandescent lights, using different colors of lights or wave lengths to get specific biologic effects. Sunshine of course has the

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

full spectrum of visible light but unfortunately includes some very damaging UV (ultraviolet) and IR (infra red) so it is easy to get very serious side effects within hours of exposure.

By

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

Examples of combination products may in

sing the non damaging colors in the visible range there is minimal risk of overexposure. In fact, your cells photo enzymes have the ability to block light input and thus limit uptake. When lase

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

rs became widely available Doctors switched to them for higher luminous power and concentrated beams but only at very high costs and extreme risks, for lasers over 0.03 watts can do eye damage

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

being so concentrated a source. They currently find the greatest medical use for ablatively burning off skin defects, such as in facial peels although the literature is full of specific heali

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

Combination pro

g effects in narrow ranges of use.

Only in the last few months have LED or Light Emitting Diodes increased in power sufficiently and reduced in cost enough to allow large arrays to have suff

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

icient power density (joules per sq cm) for reasonable treatment times.

Like plants, animal cells also react to light and can convert part of the light energy into biologic energy, primarily

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

rom triggering photosensitive enzymes most cells possess. NASA recently developed a LED array for PDT in space, as healing is greatly reduced under weightlessness. They proved it can close wo

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

unds up to (5) times faster, double the growth rate of cells, promote DNA repair, enhance production of mast cells and kill pathogens, for a major increase in healing.

There were soon FDA appr

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

ved units for use by Doctors but their cost, due to the FDA regulatory approval system are generally in the $10,000 and up range for even small hand held units. Being classed as medical devic

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

s only FDA approved units are allowed for sale to individuals but of course out of their price range. Some developed non FDA units for Veterinarians to use on animals and others came out with

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

Following aspects would a

units classed as heating pads, using mostly IR LEDS but they provide little healing, mostly a “good feeling” from the heat rays.

Properly designed units can be found at reasonable prices but f

dd to the challenges in developing combination products:

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

r individual use must be sold as experimental or cosmetic devices, as not FDA approved. In order to have biologic healing benefits they must have a power density of typically 5 Joules per squa

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

re centimeter, the level needed to trigger your cellular photo enzymes to go into action. One treatment per day is often enough as the biologic processes continue long after the treatment. A j

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

ule is one watt (of light energy) output for one second or 1/10 watt for 10 seconds, or 1/00 watt for 100 seconds, etc.

Some marketeers claim you can use a small key chain LED light but you wo

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

ld need to hold it on for days to get enough Joules of energy at one point. Also it was discovered years ago that simple light has little benefit but pulsed light has a great deal when the rep

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

Professional from academic institutions, pharmaceutical industries, health care indust

etition frequency is near 900 cycles per second, apparently a “friendly” frequency for our cells. plus the light wave length is around 600 nanometers (the red part of the visible light spectru

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

).

For cosmetic “healing”, such as large pores, fine wrinkles, acne and other surface skin problems the lower wave lengths falling in the blue and green bands are more effective but have litt

.

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

le ability to penetrate, while red can penetrate as much as 8 inches of flesh and thus aid internal healing of even organs are claimed. Treatment of the blood to kill blood parasites can be ac

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

Companies that provide selfless information through particip

omplished by shining it through the belly button area as a large artery passes behind it.

Links to research more history and application data can be found at http://PDTLights.com

Fred Pesche

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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