References - Cancer

Let us take the scenario of a seventy-year-old man, who is a nonsmoker and otherwise fairly healthy, approaching th

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

e local doctor with complaints of persistent cough, chest congestion and weight loss. Other symptoms may include di

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

Examples of combination products may in

ficulty in swallowing and loss of appetite. The physician has several options of diagnosis, but pleural mesotheliom

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

, a lethal cancer that originates in the lining enveloping the lungs, may not be considered.

There are several rea

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

ons for this. Recognition of pleural mesothelioma as a separate disease entity started as recently as the 1960s. Cu

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

Combination pro

rently only about 3000 cases are reported annually in the United States. Many doctors may not have seen a single su

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

ch case during their career. The symptoms are similar to many lesser afflictions. The only general lead is that the

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

disease seems to be more prevalent in the Pacific and Mid-Atlantic States. It is also known that the major cause fo

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

pleural mesothelioma is exposure to asbestos. But how much contact with the material leads to this disease is uncl

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

ar. Even the family members of an asbestos worker are at risk from the dust he carries home on his body and clothin

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

.

This form of cancer has a long latent period and the symptoms manifest only twenty to forty or more years after

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

Following aspects would a

exposure to asbestos. This also vitiates the possibility of correct diagnosis.

Once the doctor eliminates the chan

dd to the challenges in developing combination products:

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

es of other diseases and pursues the pleural mesothelioma line, the patient is subjected to a battery of tests and

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

maging procedures like x-ray and CT scan. Fluid collection in the thoracic cavity is an indicator, but not conclusi

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

e. Confirmation can be obtained with a pleural (pleura is the membrane covering the lungs) biopsy using an electron

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

microscope.

Since pleural mesothelioma is an aggressive cancer, early detection and immediate introduction of appr

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

Professional from academic institutions, pharmaceutical industries, health care indust

opriate management are of critical importance. The possibility of a doctor who fails to diagnose pleural mesothelio

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

a or misdiagnoses it, being sued for medical malpractice cannot be totally ruled out. But usually the law applicabl

.

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

is asbestos product liability.

It is generally accepted that pleural mesothelioma is a disease that is difficult

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

Companies that provide selfless information through particip

o diagnose. To help the doctor, the patient should inform him at the very outset about exposure to asbestos, if any

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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References - Misdiagnosed Pleural Mesothelioma

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