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One in 9 women is expected to develop breast cancer during her lifetime. One in 27 will die of it. Breast cancer attacks m

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

ainly women, however there’s 1% of breast cancer patients are men.

As we get older, the risk of getting breast cancer inc

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

Examples of combination products may in

eases. Basically, all women have a certain degree of risk of developing breast cancer. Women who have a family history of

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

reast cancer have a much higher risk of contracting this disease. There are other factors that may attribute to the higher

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

or lower the risk of developing breast cancer, some of them, e.g. Genetic risk factors, aging etc you can’t change, some

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

Combination pro

.g. lifestyle-related factors, you can.

Good news is that most of breast cancer patients will survive and still live a he

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

lthy life if diagnosed early and treated properly. The important thing we can do is do regular screening. It’s a way to c

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

heck if there are any changes in the breasts that may lead to problems. Screening includes a breast x-ray (mammogram), cl

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

nical breast examination (a physical exam of the breasts by a health care professional, CBE for short) and breast self-exa

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

ination (BSE).

All women starting from age 20 are recommended to do breast cancer screening according to the following gu

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

delines:

For women in their 20s and 30s, take clinical breast examination once in every three years, for women 40 and old

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

Following aspects would a

er, take it once every year.

For women 40 and older, take a mammogram every year. Mammography may have some limitations a

dd to the challenges in developing combination products:

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

d could miss some cancers, it is still considered to be the gold standard for early detection of breast cancer.

Starting

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

rom age 20, women may choose to do breast self-examination. The benefits of BSE may not be too obvious as it’s probably a

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

little too late when you can notice any changes. It could still be beneficial in that it helps notice any changes in the 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

easts so you can report them to your doctor.

Those women with higher risk factors of developing breast cancer, for exampl

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

Professional from academic institutions, pharmaceutical industries, health care indust

, women with family history of cancer or with a known genetic mutation of a BRCA gene, need to take extra efforts to promo

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

te awareness and take steps for prevention. Consult your doctor to discuss the risk and take necessary steps to reduce you

.

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

risk of developing breast cancer.

Breast cancer is mostly curable if found early and given good treatment. Screening is

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

Companies that provide selfless information through particip

way to detect it at its early stage. Bear this in mind: breast cancer screening can save you life. Take the time to do it

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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