Advice Pool - Health and Fitness

I was talking to a chap the other day regarding matters of health. This person, who I’ll call John for privacy purposes, was the holder of three PhDs in the field of

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

medicine and medical research.

John intimated that he had never seen a case of ‘heart disease’ killing a person.

‘Of course,’ he went on, ‘the heart organ may be

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

Examples of combination products may in

mpaired in the ‘disease’ process, however, it will always be a part of the overall process that has taken place within an organism that has been abused.’

John was d

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

escribing the law of unity in this observation.

The body functions as a whole – it never works independently in its parts.

By this I mean that the kidneys do not 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

rk for their own good - the liver does not, the stomach does not, the spleen doesn’t and neither does any other piece of tissue in the body – all parts exist and co-

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

Combination pro

exist for the health of the whole body.

Unfortunately, the prevailing influence of ‘disease causation’ suggests that the state of disease is founded upon singular p

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

rts of the body being affected in isolation – and that ‘germs, bugs, viruses etc.’ attack specific tissues.

This makes good reading for those of the ‘woolly-headed’

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

variety but in no way represents the scientific definition of health within a living organism.

Health exists due to specific conditions.

If we provide any living

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

rganism with its basic requirements – in the proper quantity and quality – a state of health will prevail.

If, on the other hand, the proper biological requirements

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

are not provided – in the proper quantity and quality – then a state of lesser health will be determined.

This state of lesser health may be called by any of the t

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

ousands of names dictated by an examination of parts of the body – with special attention to those parts readily observed as ‘diseased.’ – but the fact of the matter

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

Following aspects would a

is that any symptom of ‘disease’ is simply a recognition or sign that the whole of the organism is out of balance.

Instead of treating the symptom, as is the commo

dd to the challenges in developing combination products:

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

practise among most practitioners, we treat the whole body.

After a complete diagnosis, including an examination of lifestyle conditions, we assist people to;

• r

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

eplace dysfunctional lifestyle habits with those that produce health and recommend restful practises that allow the body to conserve enough energy to allow a healing

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

process to be affected within the organism.

We then step back and watch the body do its natural thing – that being to right itself – to return to normalcy – to res

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

tore its balance – to heal itself.

In my many years of practise I have never failed to witness the efficacy of this process.

Yes, unfortunately, some people may ‘l

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

Professional from academic institutions, pharmaceutical industries, health care indust

ave their run too late’ and if there is not enough energy remaining within an organism as it attempts to resolve and restore itself, it may expire – but again, that

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

also is a ‘right process’ of action within a living organism.

And so to reiterate – the first lesson culled from my talks with John is to recall the Law of Unity –

.

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

o realize and remember that no one part of the body is separate from any other part and that all parts work for the good of the whole.

It is our responsibility to r

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

Companies that provide selfless information through particip

ecognize this and to provide an environment in which all living tissues flourish in a state of health and harmony.

All the best in living in your own harmony.

Kevi

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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