Advice Pool - Health and Fitness

What first comes to mind when you think of acupuncture? Probably somebody sitting there with several needles inserted just about anywhere on their body from the earlobe to the wrist

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

. In fact, this is a reasonably accurate description of an acupuncture session, with these treatments lasting anywhere from a minute to over half an hour depending on the sym

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

Examples of combination products may in

toms being treated. The needles themselves are usually only inserted a little way into the skin - far enough to hold them in place and no deeper, although an acupuncture practitione

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

r may insert a needle deeper at certain points if necessary. During insertion of the needle sometimes they are twirled into place, sometimes having been warmed prior to insertion, w

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

ilst on other occasions heat is applied to the needles once they are in the skin.

As a rule acupuncture patients feel no discomfort when the needles are inserted, manipulated or re

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

Combination pro

oved, other than the very rare slight twinge. Generally, the treatment gives the patient a sense of well-being accompanied by a rush of energy and feeling warmer. Although there are

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

some patients who feel no difference during the sessions they are likely to notice their symptoms changing as weeks go by.

There are some forms of acupuncture that do not use need

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

es. The thinking behind them, however, is identical to traditional acupuncture methods, with an emphasis on the correct flow of energy in a healthy body and a fundamental kno

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

ledge of how the body works, as well as acupuncture points. The major difference is in the use of alternative methods to stimulate the acupuncture points. Sonopuncture, for e

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

xample, uses a device that produces sound waves placed on the acupuncture point. Similarly, vibrating devices such as tuning forks can also be used. These methods are gaining popula

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

ity although there is little evidence yet as to how effective they are over the more traditional needle based acupuncture method.

In use since the middle of the twentieth century,

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

Following aspects would a

he application of low voltage electrical currents to acupuncture points is sometimes practised in conjunction with the insertion of a needle, sometimes simply by touching the

dd to the challenges in developing combination products:

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

skin with a small wire connected to the electric current. The effect is that of a slight tingling only, with no pain. During the 1930s and 1940s research was carried out in both Eu

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

ope and America about the uses of electricity in western medicine although interest seems to have waned since then.

Acupressure is the most widely known variant of tradition

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

l acupuncture and uses no device other than the human hand. In this method a finger is pressed on the acupuncture point - in fact for the relief of minor symptoms such as headaches

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

it can even be self administered by the layman by simply following a diagram of the correct pressure points on the hands or feet. It can also be integrated into other massage techni

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

Professional from academic institutions, pharmaceutical industries, health care indust

ues such as shiatsu to great effect. It's important to bear in mind, however, that a professional acupressure practitioner will have a full understanding of the entire acupuncture s

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

stem - there is a lot more to acupuncture than simply finding the points on a diagram!

The adaptability of acupuncture therapy is demonstrated in applications as varied as the use

.

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

of friction, magnets, suction and even laser beams, although the use of heat in acupuncture remains the most traditional of the alternatives. Whichever application is used, be it ne

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

Companies that provide selfless information through particip

dle based acupuncture or an offshoot, acupuncture is a therapy which has helped people for centuries. As a alternative or compliment to western medicine, acupuncture is here to stay

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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What are MBO's? Management by Objectives explained, using MBO's to keep your organization moving forward. How to write MBO's.

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