Advice Pool - Health and Fitness

"Every heart that has beat strongly and cheerfully has left a hopeful impulse behind it in the world, and bettered the tradition of mankind." Robert Louis Stevenson (1850 - 1894)

Throughout the history of mankind, the heart has attracted extraordinary intrigue as the emotional and spiritua

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

l home of the soul. Physicians are however compelled to look at it as a muscle and blood machine - an engine with staggering strength and stamina - one that holds together and keeps alive our own personal universe - our body.

The normal heart is a strong, muscular pump that continuously pu

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

Examples of combination products may in

mps about 2000 gallons of blood through the circulatory system each day. It does so by beating about 100,000 times. per day. It is about the size of your fist.

The heart has four chambers and four valves. The upper two chambers are the right atrium and left atrium - these collect the blo

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

d as it enters the heart. The lower two are the right ventricle and left ventricle - these pump blood out of the heart. There are two heart valves on each side. The mitral and aortic valves are on the left side and the tricuspid and pulmonary valves are on the right side. The valves open a

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

nd close to let the blood flow in only one direction.

Right atrium: The blood returns to the heart after circulating through the body to this chamber. This dark bluish blood is brought back by two large veins called the vena cava. The right atrium holds the blood till the tricuspid valve

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

Combination pro

pens and the blood then flows into the low pressure right ventricle.

Tricuspid valve: This is located between the right atrium and the right ventricle. It is a three leaflet valve that opens one way allowing the blood to flow into the right ventricle from the right atrium.

Right Ventricl

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

e: The right ventricle receives the deoxygenated blood and pumps it through the pulmonary valve into the pulmonary arteries which fan out in the lungs. As the blood circulates through the lungs, it receives fresh oxygen and becomes bright red in color.

Pulmonary Valve: This lies between t

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

he right ventricle and the main pulmonary artery. It prevents the blood from flowing back into the right ventricle.

Left Atrium: The oxygenated blood from the pulmonary veins comes to the left atrium. The left atrium holds the blood till the mitral valve opens and allows it to enter the hi

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

h pressure left ventricle.

Mitral Valve: Unlike the other three valves, the mitral valve has two leaflets. It lies between the left atrium and the left ventricle and allows the blood to flow one way into the left ventricle.

Left Ventricle: The oxygen rich blood is pumped out by the left v

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

entricle to the rest of the body via the aorta through the aortic valve.

Aortic Valve: This lies between the left ventricle and the aorta. The aorta is the main artery that sends the blood to the rest of the body. As with other valves, it allows the blood to flow in only one direction - fr

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

m the left ventricle to the aorta.

Coronary Arteries: The heart itself must receive nourishment for its function. Oxygen and nutrient rich blood comes to the heart muscle via the right and left coronary arteries.

Vena Cava: These bring the oxygen poor blood from the body back to the righ

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

Following aspects would a

t atrium.

Pericardium: The pericardium is a double walled sac that surrounds the heart and the roots of the great vessels. It anchors the heart to the surrounding tissues and prevents it from overfilling. Serous fluid inside the sac provides lubrication and prevents friction from occurring

dd to the challenges in developing combination products:

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

during heart activity.

Common Heart diseases:

“The heart is the only broken instrument that works.” T. E. Kalem

Coronary Artery Disease: This is the most common cause of cardiovascular disease and death. It arises from blockage of the coronary arteries that bring oxygen and nutrient ric

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

blood to the heart for its own nourishment. Atherosclerosis is the main cause of this disease, and its resultant symptom of angina. Heart attack and sudden death are often the first and only symptoms of this disease.

Arrhythmia: Disorders of the heart beat are called cardiac arrhythmias.

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

Atrial fibrillation affects over 2 million Americans. There are many different kinds of heart rhythm irregularities. Some may occur in a healthy heart and be of minimal consequence. Others may indicate a serious problem and lead to heart disease, stroke or sudden cardiac death.

Heart Failu

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

e: This occurs when the heart is unable to pump blood effectively. Damage from heart attack is a common cause of this. The heart muscle can also become weak due to long standing high blood pressure, valve diseases and viral cardiomyopathy.

Other Cardiovascular Diseases:

High Blood Pressur

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

Professional from academic institutions, pharmaceutical industries, health care indust

e: This is the single most important risk factor for stroke. It also contributes to the development of arteriosclerosis resulting in coronary artery disease and heart failure. It is commonly known as the "silent killer" as it usually does not cause any symptoms.

Stroke:Like a heart attack,

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

stroke is a medical emergency and occurs due to interruption in the blood supply to the brain. It can occur due to thrombosis, embolism, or hemorrhage. It is the third leading cause of adult disability in the United States.

Peripheral Artery Disease: This affects about 8–12 million Americ

.

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

ns. It is caused by blockage to the circulation going the legs due to plaque build up. It usually causes painful cramping in the hips, thighs or calves on exertion, and it goes away on resting. This is called "intermittent claudication". People with this disease have a six to seven times hi

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

Companies that provide selfless information through particip

gher risk of heart attack or stroke.

“One of the hardest things in life is having words in your heart that you can't utter.” James Earl Jones. However when it comes to sickness, the heart is often unable to let you know until it is too late. So be kind to your heart - live and eat healthy

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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