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Originally developed as a treatment for prostate gland enlargement, Finasteride is a drug that is now also used for the treatment of male pattern baldness (male hair loss).

Du

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

ring the 1980s and early 1990s large amounts of time and money were spent on research trying to find a cure for enlarged prostate gland in men. The condition was and still is v

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

Examples of combination products may in

ery common, it affects about half of all men in their 60s and possibly 95 per cent of all men by the age of 80. As a man gets older the condition progressively worsens as the p

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

rostate enlarges putting increased pressure on the bladder. Early symptoms may show up as a difficulty maintaining urine flow and the need to urinate frequently. This progresse

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

to more painful and serious conditions such as infections of the urinary tract and the development of bladder stones.

By 1993 medical researchers had found that the condition

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

Combination pro

was caused by a hormone called dihydrotestosterone (DHT). It then became clear why the condition was only found in men, as DHT is created from the male hormone testosterone by

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

the enzyme 5-alpha-reductase (As a side note, DHTs’ only known positive role is to enlarge the male genitalia during development of the foetus). Once the mechanism of how and

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

why the prostate was being affected a drug called Finasteride was developed that prevented an enzyme called 5-alpha-reductase from converting testosterone into the damaging DHT

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

The drug was extremely successful at treating prostate gland enlargement and soon became used on a large scale. This was when the amazing 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

om/articles/finasteride_side_effects.htm" target="_blank">finasteride side effects were discovered, for it was observed that Finasteride was actually preventing male patter

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

n hair loss in the patients being treated. This was a remarkable breakthrough, backed up with compelling statistical evidence.

It is now generally accepted that DHT causes hai

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

Following aspects would a

r loss, although the actual mechanism that causes the condition is still unclear. One theory is that DHT interrupts the hairs normal growth cycle by shortening the growing phas

dd to the challenges in developing combination products:

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

(Anagen) of the hair and lengthening the resting phase (Telogen).

Once the link between DHT and hair loss was established it opened the floodgates with companies trying to pr

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

oduce the most effective form of anti-baldness drug. Research soon found that a much lower dosage of the drug, about one fifth of that required for treating prostate gland enla

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

rgement was required to stop hair loss. This was good news for creating a safer drug but there are still a number of side effects that should be considered before use. These si

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

de effects include erectile dysfunction, loss of libido and gynecomastia i.e. the enlargement of the breasts in men. The manufacturers claim that these side effects will affect

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

Professional from academic institutions, pharmaceutical industries, health care indust

less than 2% of users.

In December 1997 Finasteride was approved as safe for use in treating male pattern baldness by the American Food and Drugs Administration (FDA). Finaste

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

ride is now probably the most a very effective drug for preventing hair loss in men but should be taken with caution as the possible side effects can be long lasting. Some doct

.

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

ors can also prescribe Finasteride for women but it should never be used by pregnant women or women who may become pregnant as its side effects can cause defects in the unborn

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

Companies that provide selfless information through particip

foetus.

Please visit our web site for more information about the causes of alopecia

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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You don’t have to be made of money to be an investor. There are many investments ideas for small investors that you probably aren’t aware of. And these investments can be a lot closer and simpler than you think.

Owning a home is every individual’s dream. However, most people cannot afford to buy a home with savings of their own and need their purchase to be financed by a financial institution. A loan provided by a financial institution to purchase or renovate a home is known as home finance. Purchasing a home offers several advantages. Perhaps the biggest advantage is that it allows you to build home equity when you pay the mortgage each month.

To enjoy summer in good health, protect your skin from the sun and learn how to beat the heat with these simple measures.

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