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Hormones are major links in the mind body connection. They are chemical the chemical messengers that can turn on and off a variety of genes in every cell in your body-including your brai

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

n! All known hormonal imbalances may manifest as psychiatric disorders, such as depression, mania, anxiety, ADD, memory disturbances, dementia and even psychosis. On the other hand, bear

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

Examples of combination products may in

ing the burden of any of these disorders, over time, will affect your hormonal function as well. Hormonal imbalances also mimic the side effects of anti-depressants by causing weight gai

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

, brain fog, sexual problems, and depleted energy levels. It is clear then, that hormonal problems go hand-in-hand with depression, and sorting out "hormone triggered" depression from cl

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

inical depression is not always easy. Most patients have a mixture of the two. For this reason, in the practice of Whole Psychiatry, a detailed assessment of the hormonal systems should

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

Combination pro

e a routine part of every psychiatric evaluation.

A hormone called cortisol (made by your adrenal gland) is part of the body's shock absorber system. We all drive down the road of life.

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

and we hit real or imagined pot holes. If our shock absorbers are functioning well, its like we are driving a Cadillac. We feel the pothole, but only briefly and then we make a quick r

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

ecovery. If we have poor shock absorbers, we feel like we are driving an old pick-up truck over a dirt road. We hit a pot hole, are stunned by it, and may even veer off the road.

What d

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

termines how our shock absorbers work? Some of it is genetic, and some of it is set by the time we are 11 or 12 weeks of age! In addition, chronic stress, nutritional and chemical factor

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

s, social environments, attitudes, percieved sense of control, spiritual orientation, and interpretation of the meaning of events play an important role.

Your body's glands take their c

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

es from your brain. When an event is perceived, a meaning is assigned to the event, and a hormonal response appropriate to the assigned meaning occurs. Thus your brain determines the exa

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

Following aspects would a

ct timing and amount of cortisol that is released into your blood stream: too much cortisol at night, and you can't fall sleep, too little cortisol in the morning, and you can barely pee

dd to the challenges in developing combination products:

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

l yourself out of bed!

By the same token, your brain then gets a message from your adrenal glands via the cortisol in your blood stream, which provides a status update on hormone produ

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

tion and release. The constant relay of information between your brain and your adrenal glands keeps your brain, immune system and stress response functioning normally.

But this system

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

's equilibrium can be upset when you take a blow from, say, depression, manic depression, anxiety, chronic stress (such as a divorce or chronic illness), chronic pain, or recurrent bouts

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

of low blood sugar. In fact any of a number of hormonal imbalances (e.g., adrenal, thyroid, reproductive hormones) are one of the major reasons that many anti-depressant treatments don't

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

Professional from academic institutions, pharmaceutical industries, health care indust

work, or why patients with bipolar disorder are not stabilized.

In summary, if you have a mood disorder, check into your hormonal status, looking at adrenal function, thyroid function

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

(check a TSH, free T3, free T4, reverse T3, body temperature), blood sugar regulation, reproductive hormones, and melatonin.

Give the wide variety and effect of pesticides and hormone i

.

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

terrupters in our world, I strongly advocate for organically grown foods. Aside from the superior nutritional content, and health benefits seen in experimental animals, there is growing

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

Companies that provide selfless information through particip

concern that the chemicals we accept in our environment cause significant hormonal problems in the population at large, by mimicking or blocking the functions of our own hormonal systems

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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