E-Articles - Health and Fitness

Osteoporosis affects millions of people and is the second biggest health problem worldwide. Osteoporosis is the condition wherein the bo

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

nes lose mass and the bone tissues deteriorate. Osteoporosis makes bones thin, fragile, and highly susceptible to fractures.

How does

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

Examples of combination products may in

steoporosis occur? The body continuously eliminates and creates bone cells. As a person grows old, usually starting in the 30’s, the bod

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

’s process of creating bone cells becomes slower than the process of removing them resulting in a great deficit in bone mass. In additio

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

n to aging, other factors that make a person at risk of osteoporosis are smoking, sedentary lifestyle, early menopause, and family histo

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

Combination pro

y.

Known as a silent disease, osteoporosis manifests itself only when the condition is already serious. Most people who suffer from ost

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

oporosis had no idea they had the disease until they experience a fracture or severe pain in the back. What most people are not aware of

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

is you can prevent this disease early in life through exercise and daily calcium intake.

For those at risk of developing osteoporosis

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

r already diagnosed with it, physical therapy for osteoporosis is one of the best ways to fight this disease. Many qualified physical th

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

rapists specialize in the treatment of osteoporosis. Physical therapy for osteoporosis begins with a thorough physical evaluation where

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

he therapist identifies restrictions, imbalances and, specifically, what activities and movements the patient is capable of or is limite

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

Following aspects would a

d to doing. The evaluation serves as the basis for the creation of a customized physical therapy program

Physical therapy for osteoporo

dd to the challenges in developing combination products:

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

is patients without a fracture includes strengthening exercises and resistance exercises intended to increase bone mass and make bone-su

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

porting muscles stronger to help prevent fractures. To ease the stress on your bones, your physical therapist will also teach you about

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

body balance, body mechanics and posture. Your therapist will also work with you to find out if there are any risks to you at home and a

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

work such as specific activities that can lead to bone fracture.

Physical therapy for osteoporosis patients suffering a fracture invol

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

Professional from academic institutions, pharmaceutical industries, health care indust

es specific exercises and other treatment methods designed for pain relief and bone strengthening as well as prevention of fractures in

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

the future.

In addition to exercises, physical therapy for osteoporosis may also include massage, manual therapy, exercises such as Pil

.

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

tes, tai chi and yoga and heat and cold therapies for pain management.

Physical therapy for osteoporosis seeks to strengthen bones, inc

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

Companies that provide selfless information through particip

ease flexibility and manage pain. It also increases the patient’s awareness of the body and develops responsibility for their own health

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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