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Insomnia is a common condition seen by family physicians. The usual short-term treatment for it is medication that invo

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

lves hypnotics. These medications are habit-forming drugs and with long usage people can become dependent on them.

The

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

Examples of combination products may in

problem can start for many reasons. In many people who work in shifts, the body rhythm is disturbed disturbing the no

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

rmal sleep pattern. In many young mothers the sleep pattern gets disturbed waking intermittently at night to look after

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

the baby’s needs. Caring for an old relative at night can also disturb the sleep pattern.

In almost all of these case

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

Combination pro

, the subconscious mind has got the message that sleep would put someone at risk. So in order to deal with this perceiv

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

ed ‘danger’, the mind goes into an alert state and does not allow the body to sleep. No amount of conscious logic or re

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

ason can convince the subconscious to let the body sleep. This increases physical tension.

In order for the body to r

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

est, the tension has to be reduced. When the perceived fears are addressed, the body goes into a state if tiredness and

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

then it is allowed to fall asleep. One of the exercises that I have suggested to my patients is this: At bedtime, whe

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

you are going to sleep, sit in the bed. Close your eyes. Take a deep breath in and then through your nose push the bre

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

Following aspects would a

ath out forcefully but slowly. Next, take a deep breath and this time breathe out slowly and easily through the nose. C

dd to the challenges in developing combination products:

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

ontinue breathing like this with alternate breaths till you start to fall asleep.

With simple sleep problems, this exe

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

rcise works well.

The underlying reason for most of the sleep problems is fear. Fear of the future is the worry. If fe

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

ar issues are addressed in counseling or psychotherapy, sleep can become better. The other reason of sleep problem is a

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

ger. Most of the people would be unaware that they are carrying anger in their bodies. They might feel that because the

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

Professional from academic institutions, pharmaceutical industries, health care indust

y do not worry, sleep disturbance is simply a disturbance of the body rhythm. In almost all such cases that I have see

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

n, anger has been an underlying issue. Addressing the anger benefits sleep.

Sleep disturbance is commonly seen in anxi

.

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

ety, depression, psychosis and mania. Many psychiatric conditions start with disturbed sleep. It is important to take i

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

Companies that provide selfless information through particip

nsomnia seriously. It is good to address the issue as soon as it starts than to let it build up and cause complications

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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