Advice Pool - Health and Fitness

Most rhinoplasties are performed because the patient desires an improvement in appearance and/or nasal function. (S

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

)he may simply want a nose which is in harmony with the rest of the face rather than one which is out of proportion

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

Examples of combination products may in

with respect to the other facial features.

Rhinoplasty surgery is as much artistic in nature as it is scientific,

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

rarely are any two of patients' noses identical. Each patient’s nose should fit his or her face. Dr. Simoni reco

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

mends computer generated before and after pictures during consultations; so every patient can explain and observe d

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

Combination pro

esired changes prior to surgery. The alterations should be determined by many factors, including one’s height, age,

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

skin thickness, ethnic background and configuration of other features such as the forehead, eyes and chin. All in

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

ll, Dr. Simoni believes in a natural looking nose rather than one which appears to have been operated upon. No pati

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

ent really wants an assembly line nose job; they want a nose individually tailored to their own features.

Rhinopla

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

sty is considered an outpatient procedure. Rhinoplasty is a very delicate operation and is extremely different from

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

other plastic surgery procedures such as breast implant or tummy tuck. In the hand of a good rhinoplastic surgeon,

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

Following aspects would a

rhinoplasty carries a minimal post operative discomfort. The nose is reduced in size by removing excess bone and c

dd to the challenges in developing combination products:

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

artilage. The remaining structures are repositioned through a series of carefully planned internal nasal incisions

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

Dr. Simoni does not recommend “packing” the nose after surgery. With the elimination of nasal packing, pain, swelli

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

g, bleeding, discoloration, etc., are dramatically reduced making the recovery period much more pleasant for the pa

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

tient. Dr. Simoni recommends a special technique of suturing the internal nasal tissues back in place eliminates th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e necessity of packing.

An often-asked question by patients contemplating rhinoplasty is “do you have to break my

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

ose?” In a new technique, an specialized surgeon makes an incision into the nasal bones when they need to be repos

.

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

itioned thereby eliminating the more antiquated technique of “breaking” the bones and resetting them. Dr Simoni fee

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

Companies that provide selfless information through particip

ls this technique allows for better control of the operation and reduces the patient’s anxiety about having surgery

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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