E-Articles - Reference and Education

A friend of the Greek philosopher Isocrates spotted once a tall young man with large strong arms in a gymnasium of the ancient agora in classical Athens and remarked! “He is an ideal model to become a good boxer with a little training, he said”.

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

“Yes, replied Isocrates, but only if the wining trophy hangs high up and he has only to win it by reaching for it”. We observe in nature that tall trees do not always resist storms more than the smaller shrubs, but some times uproot and crumble ea

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

Examples of combination products may in

sier instead. The strongest wood in nature is a little shrub called “crania” which bares delicious read fruit in mountains of Europe in early winter. It is valuable wood for making shepherds sticks and a reliable defending weapon against any given

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

danger.

In the kingdom of insects, we observe the lice that are the smallest and most disgusting parasite in nature upset whole societies with their microscopic colonial skill. “Weight, said the well-known German physician Louis Kuhn, is not ind

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

ication of power but rather serious metabolic disease”. A hyper-muscleman may appear stronger than a man of nerve and sinew does, but he cannot do the work or endure the disease as his slimmer brother does. A well-proportioned healthy body is usua

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

Combination pro

ly elastically supple like weaving reed, and elegant like cypress tree. The impressive power of a boxers and wrestlers is due to the gravity of earth. Outside in space where there is no gravity, mass-weight has no power.

Mass and physical strengt

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

h does not represent the real inner power. What is power then? Certainly not weight neither lots of food and regular gymnasium. All of them waste energy for transportation, digestion, and exercising when abused excessively. Every gram of food more

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

than the body requires, means waste of energy in expelling it again. If we leave this excess of food and replace it with extra work instead, we will gain both in body‘s strength and business profitability as well.

A physical power is not generat

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

ed in the stomach with lots of food and drink, but from a long and restful sleep. Tiredness is not an indicator for food, but always for sleep; we renew our energy in the bedroom and not in the dining room. Excess of food usually kills not only ma

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

ny dreary hours, but kills also many dreary people. We observe many enthusiastic athletes who spend lots of time in the gymnasiums to become strong physically, as they say. Of course, they eat a lot if they exercise a lot, but what is the use? Whe

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

with less food and exercise we become quickly healthy and strong, saving time, money and energy. We know from experience that when the body is overdeveloped the brain usually is underdeveloped.

Corpulent (young) people usually are often course a

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

Following aspects would a

nd make their living by fighting or as bouncers in nightclubs. It has been said, that when the muscles of the ancient Hellenes started to expand, they lost also their admirable culture simultaneously. They violated their well-known proverb “miden

dd to the challenges in developing combination products:

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

agan”= nothing in excess. Perhaps they were misleading themselves by the course and spiritually indifferent Roman conquerors. The ability to do well in our work comes from the heart, lungs, brain and soul. The soul needs no nourishing at all, the

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

brain almost next to nothing and lungs with heart so little, that I do not need to mention here at all. All physical power comes from the breath, mental from the brain and spiritual from the soul.

Man is a gigantic electric dynamo and does not ne

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

ed many coals like a steam engine to produce power; he generates enormous energy with pure food and less of it. We need an alert brain, steady nervous system, elastic body and soul courage to be whole as human beings. None of those qualities must

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

be absent if we wish to succeed in life. No one can think and a waste his energy with heavy meals and hedonistic excessive pleasures at the same time. Saving nerve energy is more vital, than economical thriftiness. The illusive impression that on

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

Professional from academic institutions, pharmaceutical industries, health care indust

e feels stronger after meal is the waste of nerve energy to through off the excess or unnatural food from the body. In other words, it is a reaction of the body against the unwanted intruder. This is the reason that misleads many unfortunate indiv

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

iduals into gluttony, alcoholism, narcotics, insolvency, jail and eventually death.

The orthodox medical profession has a sacred duty to enlighten humanity and to prevent them from early physical and mental degeneration. That prevention is more e

.

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

ffective and less costly therapy than the pharmaceutical prescriptions, no one can deny. The healing profession supposed to be educational one, and not exclusively profitable institution that keeps people in ignorance for their personal gain. We

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

Companies that provide selfless information through particip

need more enthusiastic educating doctors to distribute knowledge to humanity beside with their therapeutic services; and not dispenses of drugs that enriched the pharmaceutical industries and their own coffers.

Dr Dimitri Karalis

South Afric

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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