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People have many different ideas about what hypnosis looks like. Some think of a hapless hypnotized volunteer at a Las Vegas show clucking like a chicken. Others t

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

hink of crime witnesses being hypnotized by police psychologists. Still others think of horror movies where a hypnotized person became little but a mindless zombie

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

Examples of combination products may in

, obeying the commands of his hypnotist no matter how dreadful.

What is Hypnosis?

The truth is far less glamorous. Hypnosis is merely a fancy word for a light tr

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

ance, a state somewhere between waking and sleeping. There are many hypnosis techniques available to help induce this trance. While in this trance, hypnotized subj

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

cts tend to be highly attuned to some stimuli (e.g., the hypnotist's voice) while ignoring other stimuli altogether (e.g., not realizing whether the room is hot or

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

Combination pro

cold). People in hypnotic trances are also more suggestible and may have decreased inhibitions. A hypnotic trance, however, is easily broken, and at no time is a

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

hypnotized person ever completely out of control of his or her behavior.

How is a Person Hypnotized?

There are many hypnosis techniques to induce a hypnotic tran

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

e. Some hypnosis techniques involve using props like a constantly moving spiral or a glittery gold watch. The most simple hypnosis technique, however, is called pr

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

ogressive relaxation and requires nothing more than the hypnotist's voice.

To use this hypnosis technique, the subject should sit or lie down in a posture he or s

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

he finds comfortable. Soft music may be played in the background if this is agreeable to both hypnotist and subject.

In a soft but firm voice, the hypnotist shoul

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

then draw the subject's attention to the major muscle groups, starting with the feet. The subject should be asked to tense the muscles in his or her feet, hold th

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

Following aspects would a

em for a count of three, and then relax them. The hypnotist should then move up the subject's body, focusing on calves and knees, thighs, buttocks, etc. After ever

dd to the challenges in developing combination products:

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

y few muscle groups, the hypnotist should remind the subject to maintain the relaxed state (e.g., "You are now completely relaxed from your stomach to your toes…")

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

As the hypnotist reaches the subject's neck and face, additional suggestions of sleepiness can be given (e.g., "You're so relaxed that your eyelids are heavy. Le

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

your eyes close as you lie there and listen to my voice.")

What Next?

Once this hypnosis technique has been used to induce trance, the hypnotist can ask questio

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

ns, suggest visualizations (e.g., having the subject visualize him or herself turning off the "pain" switch in the brain), or implant post-hypnotic commands (e.g.,

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

Professional from academic institutions, pharmaceutical industries, health care indust

"When you wake up, you won't feel like smoking").

Some people slip naturally from trance to a sleep state from which they awaken calm and refreshed.

The best hy

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

nosis technique, however, is to awaken the subject. One common way to do this is by counting from ten to one, giving the subject cues on how his or her body is wak

.

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

ing up. (For instance, "Ten. You are starting to wake up. Nine. Your feet are light and ready to dance or walk. Eight. Your legs are ready to carry you wherever yo

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

Companies that provide selfless information through particip

u want to go. Etc.)

After a hypnotic session, be open to feedback from your subject. No matter how skilled a hypnotist you may be, there is always room to improve

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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