Your Space - Health and Fitness

With nearly half of the male population in the United States suffering from pattern baldness, th

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

e industry that deals with the treatment for baldness has become a $1 billion industry. Since t

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

Examples of combination products may in

e 1980s, the development of drug treatments for male pattern baldness has been developing signif

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

icantly. Over time, there has been increased understanding in the way hair grows. Advancements

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

n treatments have been moving along steadily. Research on this subject continues to be well fun

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

Combination pro

ded, enabling many scientifically proven treatments to be introduced.

Concerns

It is easier to

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

prevent the hair from falling out than it is to encourage hair growth from follicles that have g

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

one dormant. During a double-blind study where some subjects were given placebos, 72% of baldin

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

men on placebos lost their hair within a 24-month period. This is compared to 83% of the parti

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

cipants who were given a real treatment and experienced either no more hair loss or re-growth.

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

urprisingly, placebo treatments often have reasonable success in treating baldness, though not a

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

Following aspects would a

high as the products being tested. The placebos also have similar side effects as the products.

dd to the challenges in developing combination products:

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

For example, one of the products being tested during a double-blind study had a sexual side ef

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

ect in 3.8% of the people given the product, compared to the 2.0% in the placebo group.

Three "

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

P's"

There are three principles people need to follow while being treated for baldness. These

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

rinciples are known as the "three P's." The three P's are: proven treatments first, take pictur

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

Professional from academic institutions, pharmaceutical industries, health care indust

es, and be patient. Following these three principles is important to producing positive results

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

Effectiveness of treatments

The average hair loss treatment begins to take effect about six m

.

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

onths after you begin taking the product. These products will generally take up to 24 months to

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

Companies that provide selfless information through particip

xhibit optimum results. Hair loss treatments take time due to the hair cycles hair goes through

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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