E-Articles - Health and Fitness

In her book, “Life and Death in Shanghai”, Nien Cheng describes her life in China during Mao’s Cultural Revolution. Because she and her late husband had worked for a foreign firm, her home and all her possessions were confiscated by 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

he Red Guard, her daughter was tortured and then killed, and she was imprisoned and held in solitary confinement for six years. Ms Cheng was in her fifties when all this happened.

Conditions in prison were terrible and several times 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

e came close to death. Describing one on her lowest points, when she barely had the strength to stand, she writes:

“...I thought that if I was going to survive the Cultural Revolution, I must discipline myself with physical and menta

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

l exercise. Inspired by my own resolution, I stood up rather abruptly. Dark shadows almost blinded me, and I had to sit down again. But from that day onward, I devised a series of exercises that moved every part of my body from my h

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

ad to my toes, and did them twice a day. At first the exercise exhausted me, and I had to interrupt it with frequent periods of rest. Also I had to avoid the prying eyes of the guards, as exercise other than a few minutes of walking

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

Combination pro

in the cell after meals was forbidden. Nevertheless, I managed to exercise each day and after a few months recovered my physical strength somewhat, as well as my feeling of well-being.”

Several years later, the political situation in

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

China shifted and Ms. Cheng was released from prison. Despite all the hardships she had been through, her health quickly improved. Her friends commented that she looked much younger than her actual age. Eventually she moved to the U

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

nited States.

It was fascinating for me to read about Ms Cheng’s system of movement exercises because it closely parallels a procedure described in the book “How to Learn the Alexander Technique - A Manual for Students” by Barbara and

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

William Conable. This book emphasizes a procedure the Canables have named “body-mapping” - essentially a systematic process of exploring on your own body precisely how the major joints and muscle groups work.

This is not the sort of

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

study one usually associates with anatomy - what I think of as “anatomy at a distance”, that is learning about the human body without relating it to the body of the student who is doing the learning. Nor is it at all like the detailed

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

study of cadavers done in medical schools.

Body-mapping is all about the practical application of basic anatomical knowledge to yourself as a living organism, learning about how you function at rest and in movement.

In their book, th

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

Following aspects would a

Conables write:

“In recent years some (Alexander Technique) students have expressed a longing to do flexibility work but have assumed they couldn’t devote enough time to it. To one of these students I said one day, ‘Well, you could

dd to the challenges in developing combination products:

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

do worse than simply put your joints through their range of movement each day.’ He came back a week later and said, ‘I did what you suggested and it was amazing.’ “What was that?’ I asked. ‘Put my joints through their range of motion

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

ach day.’ He showed me how much flexibility he had gained in a week doing that, and we began to systematically play with the idea. Sure enough, it works like magic and takes only about five minutes a day, with no necessity that the f

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

ive minutes be consecutive. The student simply begins with the joint of the head and the spine...rotating the head and tilting, then moves on the the jaw...then on to the ribs, moving them at their joints with the vertebrae by taking

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

good breath. Then the student moves all four joints of the arm structure and the hand joints. Then the spine, bending forward, backward, to each side, spiraling, and twisting. Then the hip joint, knee, and ankle and the foot joints

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

Professional from academic institutions, pharmaceutical industries, health care indust

. That’s it. Done correctly this routine increases flexibility faster than anything I know, and I have wondered and wondered why. I now think two factors contribute, first the quality of attention brought to the movement, which is t

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

e kind of attention that makes it possible for the body to learn from each movement. Second, some of the movements are ones that many people rarely make, like rotation at the upper arm joint with the shoulder blade and rotation at the

.

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

hip joint. The body seems to delight in these movements and the availability seems to free the joint.”

If you’d like to become more flexible, the experiences of Ms Cheng and of Baraba Connable’s students point to a simple, efficient

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

Companies that provide selfless information through particip

and effective way to achieve that goal.

***

“Life and Death in Shanghai” by Nien Cheng was first published by Grove Press, New York, 1986. It is currently available in a paperback edition. The quote cited above is found on page 203

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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