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Chemotherapy is the use of drugs to treat cancer patients. These drugs can be used to reduce the size of tumors prior to surgery, or as the primary treatment when the patient is

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

no a candidate for surgery. Chemotherapy is effective because the toxins have the greatest effect on fast growing cells like the ones found in tumors. Normal, fast growing cell

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

Examples of combination products may in

s, like the cells of bone marrow, the digestive tract, mouth, stomach, and hair follicles (causing the recognizable hair loss of chemotherapy patients) can also be effected. Com

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

mon side effects of chemotherapy include anemia, nausea, vomiting, fatigue, diarrhea, skin rash and pain.

Alimta combined with the standard drug, Cisplatin, is the first and on

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

ly chemotherapy regimen to have proven effective at prolonging the life of malignant pleural mesothelioma patients when surgery is not an option. Clinical studies have shown tha

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

Combination pro

t the average life span of patients who received the regimen was increased by up to 30% as compared to Cisplatin alone. 50.3% of patients receiving the combination survived a ye

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

ar later, while Cisplatin alone had a 38% survival rate within a year. Alimta-Cisplatin is the only drug regimen to be approved by the FDA for non-surgical treatment of malignan

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

t pleural mesothelioma.

Treatment with Alimta

Alimta is a drug that is administered by a doctor. Frequency and dosages of treatment depend upon the specific case. Patients rec

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

eiving Alimta treatment are required to begin taking folic acid vitamins 5 to 7 days before treatment to help reduce side effects. The dose of folic acid depends upon the specif

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

ic case and the advice of a doctor, but standard doses are between 350 and 1000 micrograms (the amount in an average multi-vitamin pill). Patients will usually be required to co

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

tinue taking folic acid for 21 days after their last cycle of Alimta.

A doctor will also administer a muscular injection of vitamin B-12 during the week prior to treatment. Reg

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

Following aspects would a

ular B-12 shots will continue during treatment, and will most likely be given of the same day as Alimta.

An oral steroid known as dexamethasone can reduce skin rash and other s

dd to the challenges in developing combination products:

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

ide effects. Most Alimta regimens will include a twice daily dose on the day before, day of, and day after treatment. Patients will be asked to stop taking anti-inflammatory dru

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

gs, such as Ibuprofen, and refrain from alcohol.

Side effects of Alimta

Vitamin B-12 and folic acid can usually reduce the side effects of Alimta treatment, but there can be s

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

evere side effects that may require reducing, suspending, or stopping treatment. Patients may be aware of the side effects in a category known as patient felt toxicities. Some o

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

f the most common of these side effects are listed above. If a patient experience these side effects or any other unpleasant reactions he or she should inform the doctor.

Paper

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

Professional from academic institutions, pharmaceutical industries, health care indust

toxicities are the category of side effects that a patient may not be aware of. These side effects can include changes in blood cells or asymptotic deterioration of internal or

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

gans. Alimta treatment will include regular laboratory tests to monitor the possibility of these side effects.

Patients receiving Alimta-Cisplatin regimen should strictly follo

.

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

w the advice of their doctor. If you or someone you love is receiving this treatment, don’t be afraid to express any problems or concerns with your doctor. Regular and open comm

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

Companies that provide selfless information through particip

unication is the best way to reduce and prevent serious side effects of chemotherapy treatment

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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