E-Articles - Health and Fitness

Due to the dramatic increases in obesity over the past 20 years, it has now reached epidemic proportions. Thirty percent of adults over the age of 20 are obese in the United States, or 60 million people. This epidemic includes not only adults, bu

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

t children as well. The percentage of young people who are overweight has more than doubled in the last 20 years. There are now 9 million children between the ages of 6 -19 who are considered overweight.

WHAT IS OBESITY?

Obesity is defined simp

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

Examples of combination products may in

ly as too much body fat. Your body is made up of 70% water. The other 30% consists of fat, protein, carbohydrate and an assortment of vitamins and minerals. Being overweight or obese increases the risk of many diseases and health conditions, incl

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

uding the following:

*Hypertension

*High total cholesterol

*Type 2-diabetes

*Coronary heart disease

*Stroke

*Gallbladder disease

*Osteo-arthritis

*Respiratory problems

*Certain types of cancers

CAUSES OF OBESITY:

The epidemic of obesit

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

y did not crop up overnight. Obesity is a chronic condition caused by an assortment of factors. Because there are so many factors involved (genetics, environment, metabolism, overeating, etc.), it is very difficult to treat the problem.

For inst

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

Combination pro

ance, a person’s genetics and environment can increase their risk of obesity, but their behavior also influences their risk. It is easy for someone to blame heredity for their obesity, but the choices a person makes can increase or decrease their

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

risk significantly.

The choice to be physically inactive and practice unhealthy eating habits not only greatly increases the risk of obesity, but it leads to other diseases such as diabetes, cancer and heart disease. On the other hand, people w

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

ho avoid the behaviors that increase their risk can expect to live healthier and longer lives.

ADDING TO THE PROBLEM:

In the United States, our food options and eating habits have changed dramatically over the course of the past 20 years. We ar

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

e faced with an astounding array of choices in the grocery stores, many that are not healthy.

Shelves are packed with foods that are pre-packaged and high in fat, sugar and calories. Even foods that are marked as healthy or low-fat may contain m

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

ore calories than the high-fat food they are supposed to replace. It is important to always read food labels for nutritional information.

Fast food restaurants, while convenient, tend to be high in trans-fats, carbohydrates and sugar. Portion si

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

ze in restaurants has increased dramatically resulting in increased calorie consumption. If the body does not burn off the calories from eating the larger portions and drinking the sugar-laden soft drinks, unhealthy weight gain takes place.

Tech

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

Following aspects would a

nology has created many labor saving products that reduce the amount of energy we expend in our daily lives. Instead of people walking or riding a bicycle for short distances, cars are used. Instead of children playing outside, they are in the ho

dd to the challenges in developing combination products:

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

use watching television.

SOLUTIONS TO THE PROBLEM:

Promoting regular physical activity and a healthy and nutritious diet are essential building blocks for creating a healthy body. In order to accomplish this, you must create an environment that

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

supports this way of life or the obesity epidemic will continue to grow.

PHYSICAL ACTIVITY: Adding regular physical activity contributes to an amazing array of benefits for your body. It reduces your risk for high blood pressure, heart attack,

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

diabetes, and cancer. It reduces weight, alleviates the pain of arthritis, relieves depression symptoms, and reduces the need for medications.

Whatever physical activity you participate in does not have to be exhausting to be valuable. Remember,

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

any movement is better than none! Taking a brisk walk every day for 20-30 minutes will significantly benefit your body, physically and mentally.

HEALTHY DIET: Good nutrition, like physical activity, lowers the risk for obesity, diabetes, cancer

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

Professional from academic institutions, pharmaceutical industries, health care indust

, heart disease, and osteoporosis. A diet high in fruits and vegetables and low in fat builds a healthy, strong body. Although most Americans know that a healthy diet is necessary, they are slow in changing their poor eating habits.

These poor e

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

ating habits usually begin during childhood and are difficult to change later in life. Children and teenagers eat a diet consisting of too much fat and not enough fruit and vegetables. This results in a generation of overweight, unhealthy childre

.

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

n who grow into overweight, unhealthy adults.

Proper diet and nutrition and physical activity are the cornerstones for a healthy body, a body that will not be at risk for obesity or any of the other health-related diseases. However, many diet an

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

Companies that provide selfless information through particip

d exercise plans fail because people jump in headfirst and make too many changes into their routine too quickly. Making small changes slowly over the course of many months is the key to teaching your body to accept these changes and be successful

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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