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Social Space - Breast Cancer Screening Tests
How disturbing can it be for a woman to discover one day that she has a lump on her breast? This can bring out different reactions and probably unnecessary
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
emotional strain. Even before proper laboratory tests, a woman with a lump on the breast may already entertain the frightening thoughts of having breast can
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
er. The prospect of having this distressing disease can render a person emotional and physical stress. She may not be able to rest and sleep well at night
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
hinking about her condition. What if the lump is cancerous? How will she be able to cope with her situation? Will she be financially capable to pay for th
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
required medications? What if she needs to undergo mastectomy? How will this affect her sexual life? Will this make her less of a woman? These are just
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ery few of the endless questions women with probable breast cancer are asking.
Before throwing yourself into unnecessary mental and emotional distress, be s
Before throwing yourself into unnecessary mental and emotional distress, be s
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
ure to undergo viable screening tests to detect and confirm the development of breast cancer. As with any other diseases, early detection calls for a higher
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
cure rate. There are several screening tests that can be done to detect breast cancer. These include self-breast exam, professional breast exam and mammogr
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
m.
Self-breast exam is the easiest test and everyone can do it regularly in the privacy of her own room. However, no matter how easy and manageable this te
Self-breast exam is the easiest test and everyone can do it regularly in the privacy of her own room. However, no matter how easy and manageable this te
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
t is for everyone, many women do not prefer to perform the test. The fear of finding out the presence of a lump is the most glaring reason for not practicin
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
this essential breast cancer test. Women should understand that not all lumps are cancerous. Finding a lump in your breast doesn’t necessarily mean that y
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ou have breast cancer. This will necessitate further laboratory tests to confirm the presence of any cancerous cells. Even if the lump is cancerous, early
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
etection will provide you higher chances of surviving the disease.
Most doctors routinely do professional breast exam during a woman’s general physical or p
Most doctors routinely do professional breast exam during a woman’s general physical or p
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
lvic exam. Aside from checking the breast for lumps using their fingertips, doctors will also look for any noticeable difference or changes in a woman’s bre
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
st. These include dimpling, scaling and puckered appearance of the breast skin. Furthermore, the doctor will look for any fluid leaking from the nipple.
M
M
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
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
mmogram is the most effective method to detect breast cancer. Mammography is a low-dose breast X-ray. The smallest lump can be detected by mammogram. Howe
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ver, this test is not also perfect. In some cases, a lump discovered by tactile exam may not appear on a mammogram. Mammograms can also show abnormal resul
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s even when there is no cancer present. These types of test anomalies usually occur in one out of 100 mammograms.
Finally, mammogram together with a profes
Finally, mammogram together with a profes
.
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
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
ional breast exam constitutes the most effective way to detect cancer in its earliest stages. Self-breast exam on the other hand is a good practice. This w
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ll help you check your breast regularly for any developing lumps. Any lumps discovered should need further investigation by a competent medical practitioner
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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