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The male hormones androgens play a key role in the female pattern baldness. Therefor

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, Androgen Therapy for Women is the usual prescription for female pattern ba

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

Examples of combination products may in

dness. The therapy with Systemic Androgen Receptor Protein (ARP) inhibitors is usefu

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

in this case.

The main sources of androgens in women

Adrenal glands and o

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

aries are the main sources of androgens in women. Androgens like dehydroepiandroster

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

Combination pro

ne (DHEA) produced by the adrenal glands can be converted to testosterone by enzymes

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

In females dehydroepiandrosterone (DHEA) coming from the adrenal glands is the key

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

precursor of DHT. It needs conversion by both alpha 5 reductase enzymes and hydroxys

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

eroid hydrogenase isomerase enzyme.

Androgens interact with androgen receptors as t

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

stosterone and DHT. Androgen receptors can have direct interaction with the testoste

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

one, or when testosterone is converted into DHT by the enzyme named 5-alpha-reductas

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

Following aspects would a

e.

Reasons for success of Androgen Therapy for Women

Why are anti-an

dd to the challenges in developing combination products:

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

rogens so useful in female pattern baldness? It is because they tend to decrease bot

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

testosterone and dihydrotestosterone. They counter Female Hair Loss by stimu

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

ating hair re-growth.

Various uses of anti-androgens

The various uses of a

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

ti-androgens are as follows –

• Curing hair loss resulting after menstrual cycle

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

Professional from academic institutions, pharmaceutical industries, health care indust

• Curing hirsutism
• Stopping and stabilizing hair fall
• Stimulating su

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

optimal hair growth
• Helping to produce more dense hair regrowth in women

.

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

Some side effects of Androgen Therapy for Women

Some side effects of

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

Companies that provide selfless information through particip

androgen therapy include depression, nausea, bodyweight gain and loss of libido, etc

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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