E-Articles - Health and Fitness

Utter ‘Cholesterol’ and it instantly reminds one of ‘Heart Attacks’. The two are inseparable combination as far as the common man is concerned. But not many are awa

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

re, that the body inherently contains cholesterol and it performs important functions like production of hormones, Vitamin D etc.

There are two kinds of cholestero

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

Examples of combination products may in

– the good and the bad. In scientific terms, they are termed as HDL cholesterol and LDL cholesterol respectively. For being a healthy person, you should aim at inc

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

easing your HDL cholesterol and decreasing your LDL cholesterol. The main source of cholesterol is the food that we have. Hence, a careful tab over the kind of food

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

that you eat can help to control the bad cholesterol.

Many people tend to wonder whether diets like South Beach diet can prove effective o controlling LDL. South

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

Combination pro

each diet was formulated by Dr. Arthur Agatston, a renowned Miami based cardiologist. The aim of Dr. Agatston was to provide his patients with a diet chart that wil

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

aid in lowering weight as well as the cholesterol levels.

South beach diet promotes the consumption of good fats viz. the mono saturated fats and restricts the co

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

nsumption of bad carbohydrates. Instead, it stresses on having more of good carbohydrates. Dr. Agaston promises that the cut in the consumption of bad carbohydrates

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

improve the blood chemistries as well as lowers the levels of LDL cholesterol.

The million-dollar question is ‘Does it really help to lower cholesterol?’ The truth

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

is that the opinion is divided on this matter.

The South Beach diet is based on the premise that the increased cholesterol and excess insulin levels pose the maxim

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

m risk to the heart. In addition, Dr. Agaston is of the opinion that the typical American diet, which is high in processed food, is mainly responsible for increasin

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

Following aspects would a

both cholesterol as well as insulin levels. Hence, avoiding bad carbohydrates as well as bringing the weight under control is the main target of South Beach diet.

dd to the challenges in developing combination products:

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

Various clinical research and trials have shown that by sticking to the diet plan formulated by the South Beach diet does help in lowering cholesterol. The cut in t

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

e intake of processed carbohydrates and carbohydrate rich food such as rice and pasta definitely brings the cholesterol to favorable levels. Similarly, the intake o

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

f high fiber food products also aids in restoring the normal cholesterol levels.

However, some from the medical fraternity are of the opinion that the diet is not

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

s healthy for the heart as Dr. Agaston claims it to be. This is because South beach diet allows the consumption of animal products like chicken, and tender loin of

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

Professional from academic institutions, pharmaceutical industries, health care indust

eef, turkey etc. Animal food is high in saturated fats. Similarly, it is also high in proteins. A report by the Nutrition Committee of the American Heart Associatio

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

(AHA), states that, “High-protein diets may also be associated with increased risk for coronary heart disease due to intakes of saturated fat, cholesterol, and ot

.

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

er associated dietary factors.” The fact that Dr. Agaston himself takes statin drugs to control his cholesterol lends further credence to the fact that South Beach

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

Companies that provide selfless information through particip

s ineffective in controlling cholesterol.

Thus, the medical fraternity is divided in its opinion over the ability of South Beach to effectively control cholesterol

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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