Delicious - Health and Fitness

Hearing that you need a root canal can be a scary thing for a lot of people. The horror stories that have circul

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

ated have given a root canal a very bad reputation. Most dentists know this and can be friend or foe in this sit

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

Examples of combination products may in

uation.

Let's take Dentist A. He tells you that a root canal is necessary. He has worry in his eyes, he is look

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

ing afraid for you. He tells you he is sorry that this has happened and subconsciously sends the message that a

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

root canal is a bad thing.

The patient of Dentist A will most likely be afraid of the procedure. They have rece

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

Combination pro

ived the message from their dentist, a professional in his field, that a root canal is a bad thing to experience

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

. They are likely to put off the procedure, shun any advice about it, and wait until the tooth is very painful b

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

fore proceeding with treatment. Waiting until the tooth is very painful will make the procedure unpleasant, just

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

as Dentist A portrayed to the patient. In other words, a self-fulfilling prophecy.

Then there's Dentist B. He

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

tells his patient that the tooth needs a root canal but assures his patient that the procedure is pain free if

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

taken care of right away. He answers the patient's questions in a confident manner, and shows no fear to the pat

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

Following aspects would a

ient. The patient gets the message that a root canal is no big deal, just a necessary procedure. This patient mi

dd to the challenges in developing combination products:

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

ght research information on the Internet or library about root canals and go into the procedure knowledgeable an

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

d confident that there will be no pain. And that is exactly what happens.

Now, I am not saying that dentists cr

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

ate fear of root canal in their patients where none was present before. Different patients have a different leve

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

l of fear when it comes to dental work so some will be afraid no matter what is said. What I am saying is that a

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

Professional from academic institutions, pharmaceutical industries, health care indust

dentist can take a vital role in allaying the fears of their patients by instilling their own confidence level

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

to the patient instead of catering to the patient's fear or a root canal's bad reputation.

Many people have exp

.

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

ressed that they were anxious and worried before having a root canal only to be pleasantly surprised that it was

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

Companies that provide selfless information through particip

completely pain free. The smile on the patient's face after the procedure was over was a testament to that fact

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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