E-Articles - Health and Fitness

Cancer is a class of diseases or disorders characterized by uncontrolled division of cells and the ability of these to spread, either by direct growth into adjacent tissue through invasion, or by implanta

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

tion into distant sites by metastasis (where cancer cells are transported through the bloodstream or lymphatic system). Cancer may affect people at all ages, but risk tends to increase with age. There are

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

Examples of combination products may in

many types of cancer. Most cancers are named for where they start. For example, lung cancer starts in the lung, and breast cancer starts in the breast. The spread of cancer from one part of the body to 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.

nother is called metastasis. Severity of symptoms depends on the site and character of the malignancy and whether there is metastasis.

Cancer is caused by damage to DNA, resulting in mutations to genes t

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

at encode for proteins controlling cell division. Many mutation events may be required to transform a normal cell into a malignant cell. This tissue is obtained by biopsy or surgery.. These mutations can

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

Combination pro

be caused by radiation, chemicals or physical agents that cause cancer, which are called carcinogens, or by certain viruses that can insert their DNA into the human genome. Mutations occur spontaneously,

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

and may be passed down from one cell generation to the next as a result of mutations within germ lines. However, some carcinogens also appear to work through non-mutagenic pathways that affect the level o

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

transcription of certain genes without causing genetic mutation.

Treatment of Cancer

Cancer can be treated by surgery, chemotherapy, radiation therapy, immunotherapy, monoclonal antibody therapy or oth

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

er methods. Chemotherapy is the treatment of cancer with drugs ("anticancer drugs") that can destroy cancer cells. It interferes with cell division in various possible ways, e.g. with the duplication of D

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

NA or the separation of newly formed chromosomes. Most forms of chemotherapy target all rapidly dividing cells and are not specific for cancer cells. Hence, chemotherapy has the potential to harm healthy

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

issue, especially those tissues that have a high replacement rate (e.g. intestinal lining). These cells usually repair themselves after chemotherapy. Treatment of some leukaemias and lymphomas requires th

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

Following aspects would a

e use of high-dose chemotherapy, and total body irradiation (TBI). This treatment ablates the bone marrow, and hence the body's ability to recover and repopulate the blood.

Radiation therapy (also called

dd to the challenges in developing combination products:

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

radiotherapy, X-ray therapy, or irradiation) is the use of ionizing radiation to kill cancer cells and shrink tumors. Radiation therapy can be administered externally via external beam radiotherapy (EBRT

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

) or internally via brachytherapy. The effects of radiation therapy are localised and confined to the region being treated. Radiation. Hormone-sensitive tumors include certain types of breast and prostate

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

cancers. Removing or blocking estrogen or testosterone is often an important additional treatment. Pain medication, such as morphine and oxycodone, and antiemetics, drugs to suppress nausea and vomiting,

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

are very commonly used in patients with cancer-related symptoms. Cancers can be cured if entirely removed by surgery, but this is not always possible. When the cancer has metastasized to other sites in th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e body prior to surgery, complete surgical excision is usually impossible.

Prevention of Cancer

Cancer prevention is defined as active measures to decrease the incidence of cancer. Much of the promise f

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

r cancer prevention comes from observational epidemiologic studies that show associations between modifiable life style factors or environmental exposures and specific cancers. Use of exogenous hormones,

.

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

exposure to ionizing radiation and ultraviolet radiation, certain occupational and chemical exposures, and infectious agents. Alcohol consumption, Smoking (although 20% of women with lung cancer have neve

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

Companies that provide selfless information through particip

r smoked, versus 10% of men. Cancer however, compared with tobacco exposure, the magnitude of effect is modest or small and the strength of evidence is often weaker. Do not take the Alcohol and No Smoking

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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