Advice Pool - Health and Fitness

Have you ever gone to the doctor with any of the following symptoms?

-

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

Overwhelming fatigue

- Muscle aches

- Vague abdominal pain

- Diarrhea or c

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

Examples of combination products may in

onstipation

- Palpitations

- Shortness of breath

- Joint aches

Have any

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 these symptoms been accompanied by the following complaints?

- Sleep

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

isturbances

- Appetite disturbances

- Memory and concentration difficulties

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

Combination pro

- Anxiety

- Loss of interest in usual activities

- Lack of enjoyment in pre

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

viously pleasurable activities

- Altered sex drive

Has your doctor done a

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

thorough physical examination, followed by a battery of lab work and radiograp

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

hic studies, only to tell you that everything is normal?

If this sounds f

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

amiliar, you may be suffering from Multisomatoform Disorder (MSD). With

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

this disorder patients suffer from three or more unexplained physical symptoms

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

Following aspects would a

. Recent studies suggest that patients with MSD are at highest risk for

dd to the challenges in developing combination products:

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

an underlying depressive and/or anxiety disorder.

In a recent worldwide stud

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

y of patients with diagnosed depression, over half of the patients reported mu

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

tiple unexplained physical symptoms. Alone or in combination, Depression, Anxi

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

ety Disorder, or MSD can become debilitating.

If you are suffering from unexp

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

Professional from academic institutions, pharmaceutical industries, health care indust

lained physical symptoms and feel anxious or sad, you need to see your physici

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

n to rule out the possibility of MSD, Depression, or Anxiety Disorder. Unexpla

.

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

ined physical symptoms may be the warning signs of Depression, Anxiety Disorde

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

Companies that provide selfless information through particip

r, or MSD.

Remember, life is supposed to be enjoyed not endured.

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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