I Advice - Health and Fitness

Women are different from place to place, culture to culture; but no matter where we live or who we are, we sh

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

are common ground when it comes to our gender. One such commonality is menopause – the permanent ending of ou

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

Examples of combination products may in

r reproductive lives as evidenced by the cessation of our menstrual cycles. Menopause can occur naturally – a

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

s it often does – or be brought on by a surgical procedure, but the results are the same.

Menopause generall

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

y occurs during a woman’s late forties to mid-fifties and is defined by the ending of egg production by the o

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

Combination pro

aries. In addition to the cessation of egg production, the ovaries will also cease to produce estrogen – the

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

hormone responsible for keeping the intricate processes of a woman’ body in balance. The end to egg productio

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

n results in the end of the menstrual cycle. And the elimination of estrogen results in a number of menopause

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

-related symptoms. Some of the more common symptoms include hot flashes, night sweats, disruption in sleep, m

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

emory loss, vaginal dryness, loss of sexual desire, and mood swings. However, not every woman experiences eve

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

y symptom. And when symptoms are experienced, the severity with which they are experienced differs greatly fr

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

Following aspects would a

om woman to woman.

Menopause does not suddenly happen. It is a gradual process that normally occurs over the

dd to the challenges in developing combination products:

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

course of several years. However, there is also medically-induced menopause that occurs as a result of a sur

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

gical procedure.

While it is true that menopause is a physical event and manifests itself through physical s

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

ymptoms, it can also have a bevy of emotional manifestations. The ending of a woman’s reproductive life can b

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

enormously sad for some women and marks the closing of a whole chapter of life. And when you are feeling a h

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

Professional from academic institutions, pharmaceutical industries, health care indust

ost of symptoms – some of which can be disruptive to your every day routine – it can have emotional consequen

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

ces as well.

However, the experience of menopause doesn’t have to be a difficult one; today’s medical advanc

.

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

ements offer a host of therapy plans designed to minimize the effects of menopause. If you find that you are

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

Companies that provide selfless information through particip

having difficulties through menopause, consult your doctor to see what treatment options are available to you

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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