Useful Articles - Health and Fitness

What is Endometriosis?
Endometriosis, a health problem in women, is also found to be a cause of infertility. The endometrium is the tissue that lines the uterus (womb) and when this tissue finds its

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

elf outside on other areas, the resulting condition is called endometriosis. Endometriosis can be found:

• On or under the ovaries
• Behind the uterus
• On the tissues that hold the uterus in place<

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

Examples of combination products may in

br />• On the bowels or bladder.

This tissue gone astray can cause severe pain, infertility and very heavy periods.

Symptoms of Endometriosis
Pain is the most common symptom o

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

this ailment, and they are often concentrated in the abdomen, lower back and pelvic areas. Other symptoms may include:
• Painful menstrual cramps
• Pain during and after sex
• Intestinal pain
• Pain

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

ful bowel movement and urination during menstrual period
• Heavy and long menstrual periods
• Spotting or bleeding between periods
• Fatigue

Women with endometriosis may also suffer from gastroi

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

Combination pro

ntestinal problems such as diarrhea, constipation and bloating during menstrual periods.

Who gets Endometriosis?
Around 5 Million American women have endometriosis; making it a common hea

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

th problem for women. Women with this condition are averaging 27 years of age, get their monthly cycles and have 2-5 years of the symptoms before finding out they carry this condition.

Factors Raising

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

Chances of Endometriosis
• Starting her period at an early age
• Have heavy and prolonged periods (lasting more than 7 days)
• Have short monthly cycle (less than 27 days)
• Have relatives wi

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

th endometriosis (mother/sister/aunt/cousins)

How do I reduce chances of developing Endometriosis?
• Exercise regularly
• Avoid drinking alcohol and caffeine
• If you are consta

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

tly bothered by constant pain every time you have your period, consult an expert for early diagnosis

How would I know if I have Endometriosis?
If your monthly period is always accompanied

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

by pain, maybe it is time to submit yourself to a thorough examination by your own OB/GYN. Your family history will be reviewed and you may be subjected to certain procedures like pelvic exams. During this exam, your do

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

Following aspects would a

ctor can immediately see signs of endometriosis. At other times, further evaluation may be needed and you will therefore be made to undergo additional tests such as:
• Ultrasound (which uses sound waves to “see” the

dd to the challenges in developing combination products:

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

body)
• Magnetic Resonance Imaging or MRI (which uses magnets and radio waves to make a “ picture “ inside the body)

The only sure way to make sure is to undergo a surgery known as Laparoscopy. A tiny sli

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

t is made in the abdomen and a thin tube with light is placed inside to see growths from endometriosis. Sometimes diagnosis can be arrived at seeing these growths, but at other times, a biopsy (taking of a small portion

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

of the tissue) may have to be performed.

Treatment
There is no cure for endometriosis, but there are various treatments for pain and infertility that accompanies this condition. Your doct

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

r will be the best authority on this. The kind of treatment you choose will depend on factors such as: the kind of symptoms you have, age and plans in starting your pregnancy.

If you are having mild symptoms a

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd pains, you may just be made to take over-the-counter pain medications (like ibuprofen or naproxen) to bring remedy and relief.

When pain medication won’t do and you have no plans of

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

"http://www.getting-pregnant-fertility.com">getting pregnant anytime soon, you can be treated with hormone medicines. This is best for women with small growths and don’t have severe pains.

Just remember, t

.

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

e pain related to endometriosis is something that is not to be taken lightly. It can interfere with your life.

Do not wait long in consulting your doctor. There are treatments that can relieve the symptoms- m

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

Companies that provide selfless information through particip

edicines for pain relief and surgery can help overcome the infertility issue. Be educated and learn as much of it as you can. You would be doing yourself a lot of good simply by talking to family, friends and your doctor

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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