Advice Pool - Health and Fitness

Tray bleaching is probably the best and most popular way for patients to whiten their teeth. It has been in use since the 1990's a

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

nd is a procedure that has truly stood the test of time. It appears to be safe and is a most affordable option for our patients. U

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

Examples of combination products may in

like in-office teeth whitening procedures, the patient can apply the bleach to his own teeth, as often as he or she desires. For a

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

n initial expense of about $500 the patient has a shrink wrap mold made of his or her mouth. This mold is often worn at night with

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

a special bleaching solution (usually 16% carbamide peroxide solution) for a period of one to three weeks while the teeth graduall

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

Combination pro

y whiten.

During this whitening period the patient briefly stops into our office for a quick visit so that we may monitor the tee

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

h whitening process. When the teeth reach the desired shade of whiteness the process is over. Custom tray bleaching has the advant

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

age over in office light assisted bleaching techniques in that it allows the patient to have a more flexible end point. You have s

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

me control of how white you make your teeth. If you don't want super white teeth, wear the trays a shorter number of nights. If yo

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

u change your mind and want to go whiter you can resume wearing the trays. The whitening can last for years but does tend to dimin

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

sh slowly over time.

Touch ups, although not required, are usually best done once per year and are accomplished by wearing the tr

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

Following aspects would a

ys with bleaching solution for one or two nights only! (Approximate cost $25)

Although your teeth whiten during the bleaching pro

dd to the challenges in developing combination products:

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

cess, your fillings will not. Sometimes teeth can appear unevenly colored afterwards, if they have fillings that no longer match t

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

e color of the teeth. Also if you have crowns towards the front of your mouth they also will not change color and may no longer ma

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

tch.

During the bleaching process and for several weeks afterward, it is recommended that patients refrain from drinking and eati

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

g things that may stain the teeth. The teeth are temporarily somewhat porous and prone to picking up stains internally. Also, many

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

Professional from academic institutions, pharmaceutical industries, health care indust

patients report a transient sensitivity during the bleaching process. When this happens, I usually recommend they take a day or t

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

o off before resuming the whitening process.

There are many ways to whiten your teeth (light assisted in-office, over the counter

.

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

methods and tray bleaching), but tray bleaching is my favorite since most patients find it relatively easy and it allows for easy

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

Companies that provide selfless information through particip

touch-ups. Which ever way you choose, whitening your smile has never been easier and most people are very pleased with the results

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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Organizational Capital and How this effects Brand Distribution in Multi-brand Concepts.

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