Advice Pool - Health and Fitness

Clinical Depression is a serious illness marked by deep sadness, melancholia, and/or despair that disrupts the daily living of an individual. Sever

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 depression includes Bipolar Disorder (Manic Depression) and Schizophrenia among other mental illnesses. Both of these can cause serious difficul

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

Examples of combination products may in

ies with daily living, working, and relationships.

There are many treatment options available for Severe Depression. There are pharmaceutical trea

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

ments, medical procedures, medications, and psychotherapy. In the cases of severe Depression, more than one treatment is used at the same time.

Me

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

ications are used in treating severe depression. They fall into particular classes SSRIs - Selective Serotonin Reuptake Inhibitors treats a defic

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

Combination pro

iency of Serotonin in the brain.

MAOIs - monomine oxidase inhibitors blocks the monomine enzyme that breaks down neurotransmitters (Serotonin, Dop

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

mine, and Norepinephrine).

SNRIs - Selective Norepinephrine Reuptake Inhibitors works on Neuroepinephrine and 5H-T. These are the most common clas

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

es of antidepressants.

Electroconvulsive Therapy is also known as Shock Therapy. The patient is given both a general anesthetic and a muscle relax

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

r. When this procedure is done right a seizure will result - the relaxant is used to prevent this. Electrodes are put on the scalp and very control

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

led electric pulses are given and this causes brief seizure activity in the brain. The patient’s muscles are relaxed so only mild movement of the h

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

nds and feet occur. The patient wakes up a few minutes later and remembers nothing about the procedure or events surrounding it. They may be confus

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

Following aspects would a

d after the treatment. This procedure is usually prescribed to be repeated either in one month or in three months.

Vagal Nerve Stimulation is a pr

dd to the challenges in developing combination products:

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

cedure wherein a pacemaker type piece of equipment is placed in the chest. A pulse is delivered along the nerve that goes from the neck to the brai

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

n that is believed to control depression. Some relief has been noted with this procedure.

Herbal treatments are used for depression at all levels.

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

In supplement form, they can be very beneficial. Specific herbs are blended in a particular formula believed to effect mood. To get the maximum ben

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

fit’s the supplement should be of pharmaceutical grade. To be sure that you are getting what the label says you are, the metabolic pathway of each

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

Professional from academic institutions, pharmaceutical industries, health care indust

ngredient is studied at the molecular level and the interactions of the ingredients are evaluated.

These are but a few of the available severe Cli

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

nical Depression treatments currently being used. Research and new treatments are being discovered all of the time. Newer drugs with lower doses ar

.

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

coming out that will have better tolerance and fewer side effects. Depression is a serious illness but it is not without hope. There are so many r

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

Companies that provide selfless information through particip

sources and support systems that are available now. Consult with your doctor and together you can determine which treatment(s) will meet your needs

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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