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abrasion:
loss of tooth structure caused by a hard toothbrush, poor brushing tech

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

nique, or Bruxism (grinding or clenching the teeth).

abscess:
an infection of a

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

Examples of combination products may in

ooth, soft tissue or bone

abutment:
tooth or teeth that support a fixed or remov

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

ble bridge

adhesive dentistry:
contemporary term for dental restorations that in

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

olve "bonding" of composite resin or porcelain fillings to natural teeth

air abrasion

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

Combination pro

:
removal of tooth structure by blasting a tooth with air and abrasive, a relativ

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

ly new technology that may avoid the need for anesthetic

allergy:
unfavorable sy

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

temic response to a foreign substance or drug

alveolar bone:
the jaw bone that a

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

chors the roots of teeth

amalgam:
a most common filling material, also known as

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

"silver fillings,"containing mercury (app 50%), silver, tin, copper and zinc used for

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

illings

analgesia:
a state of pain relief; an agent lessening pain

anesthesia:<

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

Following aspects would a

r> partial or complete elimination of pain sensation; numbing a tooth is an example o

dd to the challenges in developing combination products:

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

local anesthesia; general anesthesia produces partial or complete unconsciousness

an

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

terior teeth:
the six upper or six lower front teeth

antibiotic:
a drug tha

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

stops or slows the growth of bacteria

ANUG:
an acronym for Acute Necrotizing Ul

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

erative Gingivitis, commonly known as trench mouth or Vincent's disease, aggravated by

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

Professional from academic institutions, pharmaceutical industries, health care indust

stress and/or smoking

apex:
the tip of the root of a tooth

apicoectomy:
su

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

rgical removal of the root tip to treat a dead tooth

arch:
describes the alignme

.

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

t of the upper or lower teeth

attrition:
loss of structure due to natural wear

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

Companies that provide selfless information through particip

ase:
cement placed under a dental restoration to insulate the pulp (nerve chamber

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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