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As aging is associated with immunological changes, the effects of stress and age are interlinked where a

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

deregulation of the immune function can have a significant impact on physical health. On the other hand s

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

Examples of combination products may in

tess can both enhance and increase the effects of aging, with older adults often showing greater immunolo

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

gical impairment to stress than younger adults. Therefore a good immune response is essential to our good

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

health. In the same way immunological alterations and disturbances can influence the progression and sev

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

Combination pro

erity of a variety of disorders and diseases, including stress related disorders.

Also stressful experie

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

nces very early in life can alter the responsiveness of the nervous system and immune system. It is possi

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

ble that prenatal or early life stress may increase the likelihood of altered immune responses to stress

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

in late life. One such alteration to the immune system includes a decrease in the ability of white blood

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

cells (immune cells) to carry out their key functions. One great example is temporary stress as seen in s

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

udents during “examination stress”. This has been seen to slow down wound healing. Children of mothers wh

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

Following aspects would a

o are routinely stressed during their pregnancy show decrease in immune function compared to children of

dd to the challenges in developing combination products:

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

undisturbed pregnancies. Similarly young children who experience abuse or neglect show abnormal cortisol

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

levels indicative of a dysregulated stress response.

Cortisol is a hormone secreted by the adrenal gland

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

s and involved in glucose metabolism, blood pressure regulation, maintenance of insulin release, suppress

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

ion of inflammatory responses. Cortisol is elevated following several stress disorders. Several stressful

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

Professional from academic institutions, pharmaceutical industries, health care indust

experiences can cause in areas of the brain involved in memory an “imprinting” during fetal development

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

and early life can alter the responsiveness of the endocrine, immune, and central nervous systems for man

.

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

y years. An understanding of such interlinked effects of stress and age is important to understand and to

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

Companies that provide selfless information through particip

determine the mechanisms involved, so that we can develop effective interventions in early and late life

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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