Advice Pool - Health and Fitness

Despite the ongoing efforts of medical scientists to reveal the factors responsible for causing multiple sclerosis, the exact reasons why the disorder occurs in otherwise healthy per

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

sons remain unknown. Although various factors are suspected to trigger the occurrence of multiple sclerosis (viral or bacterial infections) or to facilitate its progression (genetic

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

Examples of combination products may in

ysfunctions and various external, environmental factors), medical scientists haven’t yet reached a consensus regarding the exact causes of the disorder.

Multiple sclerosis is a type

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

of autoimmune disorder, involving abnormal activity of the immune system, which turns against healthy body cells instead of fighting against intruding infectious agents. The body ce

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

ls which are primarily targeted by the immune system in the case of patients with multiple sclerosis are nerve cells. In fact, the autoimmune response of the body doesn’t destroy ner

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

Combination pro

ve cells directly; the dysfunctional immune system produces antibodies that destroy myelin, a protein that wraps around the cells of the nervous system, facilitating the communicatio

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

between the central nervous system (CNS – brain and spinal cord) and peripheral nerves and vice versa.

At first, multiple sclerosis causes impairments only at the level of the cent

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

ral nervous system. In more advanced stages of progression, multiple sclerosis can involve virtually any innervated region of the body (any part of the body that contains a network o

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

nerves). Without proper medical treatment - which is most effective when administered in early stages of disease – multiple sclerosis can cause a variety of disabilities and sometim

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

es even death.

Depending on its patterns of progression, as well as the intensity and frequency of its generated symptoms, multiple sclerosis can be categorized in seven different s

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

btypes. The first subtype of multiple sclerosis is the relapsing-remitting multiple sclerosis (RR MS), the most common form of the autoimmune disorder. According to statistics, more

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

Following aspects would a

han 80 percent of all multiple sclerosis cases are of the relapsing-remitting subtype. This subtype is characterized by phases of symptomatic remission, followed by phases of relapse

dd to the challenges in developing combination products:

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

(characterized by sudden intensification of symptoms). The duration of the phases of relapse and remission vary from a patient to another, lasting anywhere from several weeks to sev

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

ral years.

The second subtype of multiple sclerosis – primary-progressive multiple sclerosis (PP MS) accounts for around 20 percent of all multiple sclerosis cases. The major charac

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

teristics of this subtype are gradual progression of the disease, with very short phases of remission. The third multiple sclerosis subtype is similar to the PP MS subtype and is cal

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

ed secondary-progressive multiple sclerosis (SP MS). Patients with primary-progressive multiple sclerosis have 50 percent chances to eventually develop secondary-progressive multiple

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

Professional from academic institutions, pharmaceutical industries, health care indust

sclerosis.

The fourth subtype of multiple sclerosis is called progressive-relapsing multiple sclerosis (PR MS) and is characterized by gradual progression with frequent phases of s

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

mptomatic exacerbation. The fifth multiple sclerosis subtype alternates between the primary-progressive, secondary-progressive and progressive-relapsing forms of the disease. The six

.

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

th multiple sclerosis subtype is benign multiple sclerosis, characterized by an initial symptomatic flare which can be followed by slow or no progression at all. The seventh and last

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

Companies that provide selfless information through particip

multiple sclerosis subtype is also very rare. It is called malignant multiple sclerosis and involves rapid progression and very intense symptoms. This subtype is in most cases deadly

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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