E-Articles - Health and Fitness

Hair loss or baldness affects the looks of a person to a great extent, making even a young person appea

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

r old. However with present day technology of hair transplantation or hair restoration, one can grow ne

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

Examples of combination products may in

w hair. Hair transplantation is a radical method and needs to be approached only as a last option.
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lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

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Hair Transplantation: The basic principle behind hair transplantation is that a small area of hair

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

bearing skin from the scalp is grafted on a bald area. In scalp reduction methods, the bald skin is rem

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

Combination pro

oved and the skin with hair is stretched over the removed area and stitched. These earlier methods used

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

to leave lot of scars and hair growth in different directions rather than in the natural direction. Pre

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

sent day technology has enabled smaller grafts giving cosmetically satisfactory results. The number of

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

people going for hair transplantation has increased tremendously over the last few years.

Proc

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

dure: Before surgery for few days, the patient has to refrain from medicines, alcohol etc to prevent bl

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

eeding from wounds. On the day of surgery the scalp is shampooed and anti-bacterials are applied. Topic

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

Following aspects would a

al anesthesia is given to the scalp. The surgery involves taking out skin graft around 1 to 1.5 cm in w

dd to the challenges in developing combination products:

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

dth and 15 to 30 cm in length from the back side of the head. The hair follicles are dissected from the

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

graft and grafted on the bald skin by needles. The grafting density, angle of graft etc is decided by

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

the surgeon. After operation antibiotics and dressings are continued till the wounds heal.

The

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

Follicular Unit Extraction (F.U.E) method is less traumatic. In this method hair follicles are extracte

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

Professional from academic institutions, pharmaceutical industries, health care indust

d from the backside of the head using needles and then grafted on the bald skin. However this method is

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

slower as compared to grafting, needs multiple sessions and if the donor skin is over grafted may lead

.

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

to pock marked appearance at the back of the head.

Post Operation: After the operation, due to

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

Companies that provide selfless information through particip

shock the hair will fall out from the grafted skin and after 2 to 3 months new hair will begin to grow

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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