E-Articles - Health and Fitness

A common injury of the elbow is lateral epicondylitis or “tennis elbow.” This problem is seen in people who perform repetitive mo

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

tion activities with overuse of the wrist and elbow. Contributing factors may include increased forces for lifting or grasping or

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

Examples of combination products may in

significant increase in repetitions over a short period of time. Some degree of underlying muscle flexibility and strength probl

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

ems are usually present before onset of this problem.

Lateral epicondylitis is microtrauma and subsequent inflammation to the ten

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

don area of the wrist extensors. It is characterized by a gradual or rapid onset of painful gripping, tenderness over the lateral

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

Combination pro

aspect of the elbow and pain with stretching of the wrist extensors. Testing of the wrist and elbow will reveal pain with resiste

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

d wrist extension, pain with passive stretching into a flexed position of the wrist and pain with palpitation of the lateral epico

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

ndyle area. Careful examination must be used to rule out other painful conditions that may cause similar symptoms.

Conservative

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

treatment is usually preferred for this problem. Symptom control may be attained through NSAID’s and physical agents such as ice,

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

iontoresis, or phonophoresis. Bracing the wrist may be used in some cases to limit the stresses contributing to onset. Activity

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

modification must also be incorporated to avoid inflammation-increasing activities. In chronic conditions, cross-friction massage

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

Following aspects would a

may be used at the lateral epicondyle to break up scar tissue and prevent calcification of the tendon.

Once symptoms have been c

dd to the challenges in developing combination products:

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

ontrolled, a regime of exercises may be incorporated into the rehabilitation process including strengthening exercises of the wris

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

t and finger extensors as well as grasping. These strengthening exercises should include eccentric and concentric muscle contract

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

ions. In the beginning, repetitions should be high and resistance low. Postural reeducation and instruction in proper lifting te

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

chnique should also be a part of the plan of care. Ultimately, there may need to be some modification in the activities that cont

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

Professional from academic institutions, pharmaceutical industries, health care indust

ibuted to the onset of symptoms. This can be accomplished through ergonomic evaluation or appropriate instruction in different te

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

chniques to perform the activity.

Early detection, thorough examination, careful control of the inflammatory phase, and long-term

.

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

strengthening and activity modification are essential in the care of lateral epicondylitis. If all of these steps are followed,

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

Companies that provide selfless information through particip

lateral epicondylitis is a manageable and treatable problem. Contact Excel Physical Therapy for more information. www.ExcelPT.co

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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