E-Articles - Health and Fitness

In the world of sports we often hear about knee injuries that derail at least an athlete's season, if not career. The most common major knee injury seen amongst athletes is a tear of the Anterior Cruciate Ligament, or more commonly known a

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

s the ACL. However, it is not just athletes that are experiencing troubles with their ACL; many people are injuring their ACL performing everyday activities. Luckily for us there have been a number of advancements in the surgical treatment

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

Examples of combination products may in

and rehabilitation of an Anterior Cruciate Ligament so that it is no longer a career threatening injury, for athletes and non-athletes alike.

Anatomy of the Anterior Cruciate Ligament (ACL)

Each one of our knees contains a number of liga

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

ents that help stabilize its movements. Of the four major ligaments contained within the knee capsule, the ACL is considered by many to be the most important because it provides the majority of the knee's stability. The ACL's main objectiv

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

is to stabilize the knee during planting and twisting motions, as well as prevent forward movement of the lower leg from the upper leg. It is able to do this by attaching to our upper leg at the front of the femur and crosses the knee to

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

Combination pro

ttach to the lower leg at the back of the tibia. When an injury to the ACL occurs it is either a partial or full tear of the ligament. The joint responds as it would to any other soft tissue injury by swelling. Some people hear a pop while

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

others just notice an extreme lack of stability and a sense of the knee giving out when weight is shifted on to that leg. Depending on the extent of the injury a patient may or may not have surgery to repair a partial tear of the ACL. As p

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

reviously mentioned it is not just athletes that experience tears of their ACL. Women tend to be more prone to an ACL injury, an unfortunate problem attributed to a number of factors. Anatomical factors that can contribute to one's likelih

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

od of injury include: strength imbalances between the hamstrings and quadriceps, joint laxity, and a large Q-angle.

Common Methods of Rehabilitation

Whether or not a patient decides to have their ACL injury repaired surgically or not usu

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

lly does not affect the plan of action for rehabilitation. Before a physical therapist is seen, the wounds must heal. Following that stage a good physical therapist will focus on reducing swelling, increasing and regaining full range of mo

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

ion, strengthening the joint and surrounding muscles, as well as re-training the muscles to achieve optimum neuromuscular control. Obviously toward the beginning activities will focus on decreasing swelling, while toward the end of rehab t

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

Following aspects would a

e physical therapist will focus their patient's strengthening on functional motions.

It is wise to follow the acronym PRICE during the early stages of recovery from an ACL tear. PRICE stands for protection, rest, ice, compression, and ele

dd to the challenges in developing combination products:

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

ation. By following these five steps each day a patient will effectively decrease their pain and swelling and better prepare their joint for the recovery process. About one or two weeks following surgery the patient will begin physical the

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

apy. The physical therapist will perform an initial evaluation consisting of background questions, and visual and physical inspection of the knee itself. With this information a physical therapist will develop a detailed plan specific to e

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

ach patient's rehabilitation needs.

Rehabilitation Timetable & Expectations

As with any injury the expected time of recovery is based on numerous factors, such as: age, extent of injury, success and type of surgery, work ethic during reh

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

b, physical therapist technique and care to detail, and overall health and fitness of the patient. An average patient, who had a traditional ACL surgery, will begin light jogging about four months post-surgery with full strength and mobili

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

Professional from academic institutions, pharmaceutical industries, health care indust

y not being full restored until about six to nine months after surgery. Most doctors will advise a patient to not return to more aggressive physical activities until their recovering leg has gained at least 90% of the strength of the healt

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

y leg. There are more advanced surgeries that can put an athlete on the playing field in about six months. This option is intended for serious athletes only and a physician should be consulted before investigating this alternative.

Any ty

.

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

e of major injury can be a setback in an athletic career, or quite a struggle to deal with in day-to-day life, and an ACL tear is no different. Surgery and rehabilitation techniques are improving each day and are therefore making the recov

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

Companies that provide selfless information through particip

ry from such an injury less painful. A patient who is dedicated to their complete recovery will have a much better experience throughout the process and give themselves a great opportunity to continue their life, be it as an athlete or not

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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