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Hypnosis has long been associated with the strange and mysterious, with side shows and faith healers. But the truth is that hypnosis is not the least bit myste

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

rious nor is it difficult to learn and master.

I would define hypnosis as a state of guided sleep known as the ‘hypnotic trance' where the subject retains awa

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

Examples of combination products may in

eness of the surroundings and responds to suggestions put during the trance state.

Marmer described hypnosis as a psycho-physiological tetrad of altered consc

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

ousness:

Narrowed awareness
Restricted but focused attentiveness
Selective wakefulness, and;
Heightened suggestibility.

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

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Hypnosis, thus, shows 3 specific characteristics:

An increased concentration of the mind
An increased relaxation of the body
An

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

Combination pro

ncreased susceptibility to suggestion.

1. Increased concentration of mind: Usually in the wakeful state, our ‘units of mind power' are scattered thr

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

ughout the brain. Any extraneous suggestions during this stage will go scattered throughout and will be captured only by a few mind power units. In the hypnoti

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

state, these units of mind power are concentrated to a point that the suggestions get absorbed and retained easier.

2. Increased relaxation of the body: Popu

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

ar hypnotic induction involves the progressive muscular relaxation techniques, whereby muscle groups are tensed and relaxed gradually to achieve a fully relaxe

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

body and mind.

3. Increased susceptibility to suggestion: This is the outcome of the preceding 2 phenomena, the concentration of mind and the relaxed body. T

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

e mind, which is in a twilight zone between the wakefulness and sleep, is highly receptive to suggestions during the hypnotic state.

In hypnotherapy, once in

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

Following aspects would a

his state, called a hypnotic trance, patients are given therapeutic suggestions to encourage changes in behaviour or relief of symptoms. For example, in a trea

dd to the challenges in developing combination products:

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

ment to stop smoking a hypnosis practitioner might suggest that the patient will no longer find smoking pleasurable or necessary. Further positive suggestion o

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

feeling of well being after stoppage of the unwanted habit will bolster the suggestions. Hypnosis for a patient with rheumatoid arthritis might include a sugg

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

stion that the pain can be turned down like the volume of a radio whenever the patient wants to.

Research in the field of psycho-neuro-immunology has opened u

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

exciting avenues as to how hypnosis, along with biofeedback and relaxation techniques, can benefit the patients in a vast array of illnesses linking mind and

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

Professional from academic institutions, pharmaceutical industries, health care indust

he body .

The trance state may be induced by various means like guided imagery, progressive muscular relaxation, deep breathing, meditation , self-hypnosis, o

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

other hypnotic induction techniques. Individuals vary in their ability to enter into the hypnotic trance state. It has been suggested that 70-80 % of people a

.

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

e hypnotizable to some extend. The feeble minded or psychotic persons cannot be put under hypnotic trance, for the simple reason that they are unable to concen

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

Companies that provide selfless information through particip

rate for any length of time. Also people who consciously resist attempts to hypnotize cannot be hypnotized.

Next Chapter: Theories of Hypnosis

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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