Useful Articles - Health and Fitness

A lot has been written in recent years about blood cholesterol levels. Not all that long ago, it was thought that eating foods high in cholesterol caused you have ha

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

ve high blood cholesterol levels, and this in turn could lead to heart disease, heart attacks, and other heart related problems. And because of these beliefs and fea

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

Examples of combination products may in

s, people were encouraged to eat foods super low in fat.

The problem with that philosophy and teaching is that it was a bit too generic and broad. There are actuall

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

y types of fat that are good for you. In fact, these so-called "good fats" are essential for proper nutrition and health. There are also "bad fats" however, which ca

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

be a contributing factor to health and heart related problems.

Cholesterol levels in your blood now have a similar distinction. Where once it was believed that you

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

Combination pro

need to have your total cholesterol levels below a certain number - such as 200mg - now it's becoming clear through scientific studies and research that this isn't

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

lways a good measuring stick. Instead, there is "good" and "bad" cholesterol. And those numbers are what's important, along with the ratio of one to another.

LDL ch

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

olesterol is considered the "bad" type, and that stands for low-density lipoprotein. Without going into a lot of medical and scientific terminology, let's suffice it

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

to say that LDL cholesterol can have harmful reactions in the human body. In contrast, there's HDL, or high-density lipoprotein, which creates beneficial reactions i

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

n the human body.

If you find it difficult to remember which one is supposed to better and which isn't, think of LDL cholesterol as the one you want to keep low - u

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

e the L at the beginning as a reminder trigger - and HDL is the one you want to keep higher (H=Higher). The ratio between your LDL and HDL cholesterol levels is impo

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

Following aspects would a

tant too.

Now unfortunately testing is still a bit imprecise. In some cases, medical professionals will still do a general cholesterol test which gives you the over

dd to the challenges in developing combination products:

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

all levels. It's becoming more common though, to at least estimate the LDL to HDL cholesterol ratios, or total cholesterol to HDL levels, but both of these are estim

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

tes instead of actual measurements.

Some say that LDL levels should fall at or below 100mg, while newer recommendations are calling for less than 70mg. When total c

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

holesterol to HDL is measured, it's said a 5:1 ratio or less is best.

Now you can get cholesterol from foods. Primary sources of cholesterol are from animal product

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

such as eggs, peanuts, flax seeds, and beef. Some cholesterol can be found in plants as well, but it's usually a much smaller amount. Most people assume - and books

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

Professional from academic institutions, pharmaceutical industries, health care indust

even teach - that there is no cholesterol in plants at all. This is a misunderstanding however, because the American FDA does not require it to be on food labels if

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

there is less than 2mg per serving.

Keep in mind though, that eating foods which contain cholesterol does not mean you'll automatically have cholesterol related hea

.

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

lth problems. Some of these problems can be caused by - or at least contributed to - by poor eating habits in general, poor exercise, and genetics.

Cholesterol leve

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

Companies that provide selfless information through particip

s can be hereditary. Like many health problems today, it's been found that some genetic backgrounds have much higher risks for certain health problems than others do

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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