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References - Breast Cancer - Paget's Disease
One of the rare types of Breast Cancer is Paget's disease of the nipple, which can appear as a rash on the nipple. The rash or other changes in the nipple can indicate
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
a cancer in the breast ducts, many times located under the nipple, which has then extended itself onto the surface of the nipple.
Sometimes this sign of breast cancer i
Sometimes this sign of breast cancer i
; 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
ndicates a small ductal carcinoma in situ (DCIS), which is a very early breast cancer that has not yet left the duct. Other times, Paget's disease of the nipple may ind
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
icate an invasive cancer somewhere else in the breast. In some cases, a woman who shows signs of Paget's disease of the nipple will additionally have an abnormal mammog
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ram or have lump in her breast.
Before we move on I want to clarify that Paget's disease of the nipple is not the same as Paget's disease of the bone, which is a severe
Before we move on I want to clarify that Paget's disease of the nipple is not the same as Paget's disease of the bone, which is a severe
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
bone disease. Sir James Paget, a British surgeon and physiologist, discovered both conditions which were first documented by him, but they are completely unrelated dise
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
ases. Paget's disease of the nipple can also affect men, although it is rare.
Paget's disease of the nipple is often first noticed when physical signs of the disease a
Paget's disease of the nipple is often first noticed when physical signs of the disease a
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
ppear. Signs of Paget's disease usually only occur on one nipple and can include persistent crustiness, scaliness, or redness of the nipple, itching or burning of the n
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ipple and surrounding areola and bleeding or oozing from the nipple and areola.
Paget's disease can often be confused with other skin conditions, such as breast eczema.
Paget's disease can often be confused with other skin conditions, such as breast eczema.
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
Breast Eczema is a highly treatable condition which can be characterized by red, itchy patches or weeping blisters around the nipple which reoccur, but clear up with p
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
oper treatment. Paget's disease does not clear up with routine treatment for eczema or infection and usually only affects one nipple.
A mammogram is the next step to c
A mammogram is the next step to c
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
heck for cancer in the actual breast. Sometimes any underlying abnormal breast mass will not be present on a mammogram. A clean mammogram combined with an abnormal nip
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
ple finding requires further investigation.
A biopsy of the nipple tissue will need to be performed. Usually this consists of a "punch biopsy" that removes a small amo
A biopsy of the nipple tissue will need to be performed. Usually this consists of a "punch biopsy" that removes a small amo
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
unt of tissue to check for cancer. If the mammogram indicates other areas of concern within the breast, biopsies of those areas should be performed.
If Paget's disease
If Paget's disease
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
is caught early while it is still confined to the nipple and underlying breast ducts, the patient typically has an excellent prognosis. However, if Paget's disease of
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
the nipple is associated with an invasive breast cancer or if the cancer has spread out of the breast to other areas of the body (metastatic disease), the survival rate
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
can be lower.
Treatment of Paget's disease of the nipple involves surgery, radiation treatment and Chemotherapy or drug therapy (such as tamoxifen). Like other types o
Treatment of Paget's disease of the nipple involves surgery, radiation treatment and Chemotherapy or drug therapy (such as tamoxifen). Like other types o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
f breast cancer, the location of the cancer will determine which type of surgery is done - a lumpectomy or mastectomy. Radiation therapy usually follows a lumpectomy.
.
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
A recent development in surgical treatment involves removing only the nipple and areola (sometimes followed by radiation therapy) in patients whose Paget's disease has n
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
o other underlying breast cancer, thus allowing the woman to keep her breast. Following treatment, an artificial nipple can be recreated using skin grafts and tattooing
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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