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With overcast skies and the snow falling across the Northeast, many find themselves covered in a blan

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

ket of depression. Winter months are prime time for Seasonal Affective Disorder, or SAD as it's comm

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

Examples of combination products may in

only referred to. SAD is a mood disorder associated with depression and related to seasonal variation

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

s of light. During the winter months, the days become shorter, so we are exposed to less daylight. No

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

big deal, right? Wrong! Here are some tips and valuable information from the National Institute of M

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

Combination pro

ental Health to help defeat those "winter blues."

Possible Cause of this Disorder

Melatonin, a sle

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

ep-related hormone secreted by the pineal gland in the brain, has been linked to SAD. This hormone, w

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

hich may cause symptoms of depression, is produced at increased levels in the dark. Therefore, when t

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

he days are shorter and darker the production of this hormone increases.

-symptoms range from excess

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

ive weight gain and/or excessive eating and sleeping during the winter months

-symptoms occur only

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

uring winter, with no recurring episodes during spring and summer

-cravings for sugary or starchy fo

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

Following aspects would a

ods

-seasonal episodes substantually outnumber non seasonal depressive episodes

Treatments

Phototh

dd to the challenges in developing combination products:

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

erapy or bright light therapy has been shown to suppress the brain’s secretion of melatonin. Although

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

, there have been no research findings to definitely link this therapy with an antidepressant effect,

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

many people respond to this treatment. The device most often used today is a bank of white fluoresce

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

nt lights on a metal reflector and shield with a plastic screen. For mild symptoms, spending time out

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

Professional from academic institutions, pharmaceutical industries, health care indust

doors during the day or arranging homes and workplaces to receive more sunlight may be helpful. One s

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

tudy found that an hour’s walk in winter sunlight was as effective as two and a half hours under brig

.

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

ht artificial light. If phototherapy is not effective, other treatments are available such as medica

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

Companies that provide selfless information through particip

tion. Other options are available. Speak with your family doctor for more information.

Never Give Up

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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