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This article will explain to you the principles that lie behind the successful resolution of mechanical low back pain (and other disorders). They are a series of logical simple to understand steps that underpin successful treatment

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

practice and effective exercise prescription

DIAGNOSIS

The first step is diagnosing what the problem is. This is done by doctors and therapists basically using two methods. The first one being what the patient says or complains

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

Examples of combination products may in

of and the second being what is actually found by the practitioner from their physical examination.

Both of these are vital suppliers of information for a correct diagnosis. The sum total of all the information gleaned from both m

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

ethods should build a picture of the exact problem that leads on to the diagnosis.

Sometimes it is possible to ascertain an EXACT diagnosis and other times it is not. Having an exact diagnosis is desirable but not absolutely essen

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

tial to successful treatment. What is important is that the existence or absence of certain conditions is ascertained so that the correct treatment and advice can be followed.

In the case of back pain it is important to be able to

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

Combination pro

put the cause of the pain down to a mechanical problem affecting the back. With reference to back pain there are certain conditions from other body systems that give pain in the back and these must be ruled out before treatment of

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

the back can begin

PAIN RESOLUTION

Before normal movement and function can be looked at the aspect of pain must be considered. This is because in the initial stages of an episode of back pain the pain is there to prevent further

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

damage occurring. It is important that this pain is allowed to settle and further damage is not caused. A few days of the CORRECT rest is normally sufficient to achieve this. Longer than this and there are likely to be more negati

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

ve effects than positive from resting unless a specific reason is given by a qualified medical person. There are modalities that are helpful in resolving pain such as medication and electrotherapy that can be beneficial.

MOVEMENT

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

RE EDUCATION

The next stage is the regaining of the normal amount of movement in the back. This is the stage at which most problems occur. This is normally for a number of common reasons. These generally revolve around the fact th

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

at there is a degree of overlap between the pain stage and this stage and people are unsure of when to begin moving, which specific movements to do, how many to do and for how long.

It is here that is so often the KEY CRITICAL POI

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

Following aspects would a

NT in the recovery process because with the CORRECT ADVICE INSTRUCTION AND ENCOURAGEMENT regarding movement and exercise therapy most back pain can be improved. If this point is missed problems begin and little by little get bigger

dd to the challenges in developing combination products:

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

and more difficult to resolve until ultimately if left long enough, which often can be just a matter of weeks, you can become a chronic back pain patient, with all its associated problems.

STRENGTH RE EDUCATION

The next stage on

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

ce the movement is well on the way to recovery is the re education of the muscles that control the area. Here again the skill is knowing when to begin the exercises, which ones to do, how many and for how long. With the back you ma

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

y be lucky and be able to resume your normal everyday activities without needing any specific strengthening exercises. There are however great many people with low back pain who would be so much better and be much more able with ag

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

ain the CORRECT EXERCISE PRESCRIPTION. For some it would undoubtedly totally solve their problem.

NORMAL FUNCTION ACTIVITY RESUMATION

Following the successful resolution of pain, movement and strength all these three come togethe

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

Professional from academic institutions, pharmaceutical industries, health care indust

r to allow the patient to resume their normal everyday activities. Here again the key is the skilful and correct advice as to how much how soon. If the previous three stages have been addressed properly this stage will follow natur

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

ally but the correct advice is paramount in preventing re injury.

SUMMARY

So there we have it. The basic stages behind the successful resolution of mechanical low back pain. This can essentially be transferred to many other musc

.

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

ulo skeletal problems. Although in black and white it appears relatively simple do not confuse something being simple and think it means it is unskilled. It requires specific knowledge at each of the particular stages.

In fact I

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

Companies that provide selfless information through particip

would go as far as to say categorically how important it is to get as far as possible a definitive diagnosis of your problem before engaging in any form of therapy whether by a third party or self help.

Copyright 2006 Robert Ryles

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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