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What is protein?

Millions of different proteins occur in nature. Protein is made of chains of amino acids held together by peptide bonds. There are ab

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

out 20 amino acids that can be bound together in various combinations to make the millions of different proteins. There are two groups of amino acids: non-esse

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

Examples of combination products may in

ntial amino acids, which are made by your body and essential amino acids, which have to come from your food.

Why does my body need protein?

Protein is

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

an important part of muscle fibre, cell walls, skin, nails and hair. You are losing protein all the time as you shed dead skin cells, nails and hair and it has

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

to be replaced. At times your body needs more protein, like when you're growing, when you're pregnant or breast-feeding, or when wounds are healing. Protein is

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

Combination pro

a source of energy for your body and the amino acids are used to make things like adrenaline and antibodies to fight disease.

How does my body digest the pr

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

otein I eat?

When you eat protein, your body's digestive system breaks it down into its component amino acids. These are absorbed into your bloodstream th

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

rough the walls of your small intestine and your liver. Your body puts the amino acids together in whatever combinations it needs, e.g. to make hair protein or

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

new skin cells. Proteins include nitrogen molecules and one of the byproducts of digesting proteins is ammonia. This is converted into urea which is filtered b

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

y the kidneys and passed as urine.

How much protein does my body need?

Health authorities in the U.S.A., Canada and Australia recommend a daily intake

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

of 0.75 - 0.8 grams of protein per kilogram of bodyweight. If you weigh 80 kilograms, that's 60 grams of protein a day. High protein (or low carbohydrate) di

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

Following aspects would a

ets will recommend more.

Can my body store protein?

No. You need to eat the protein your body needs every day. Any excess protein is converted into ur

dd to the challenges in developing combination products:

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

a and passed as urine.

Are all proteins the same?

Different proteins are made up of various combinations and amounts of amino acids. Proteins from ani

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

mals, fish, poultry, soy and Amaranth contain all of the essential amino acids and are they are easily digestible. Proteins from plants and grains do not usual

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

ly have all of the essential amino acids and you need to eat a selection of them to get all the amino acids you need.

What if I don't eat enough protein?
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
>

Most people eat more than enough protein. If you don't eat any animal products, you should eat a wide variety of plant and cereal foods. Some symptoms of pr
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
tein deficiency are: poor growth, weight loss, muscle wasting, iron deficiency, swollen feet and ankles.

Is it dangerous to eat too much protein?

Ther
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e are risks associated with following a high protein diet for a long time. Your kidneys have to collect and filter more toxic byproducts. This may affect the f
.

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
unction of your kidneys, particularly if you have diabetes. It is possible for calcium to be lost from your body. If animal products are your main source of pro
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
tein, you should avoid those that are high in saturated fats and cholesterol because they will increase the risk of a number of diseases including heart disease

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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Your Space - Protein - Its Place in Your Diet

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