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Ehlers-Danlos syndrome (EDS) is a genetic disease. There are several different types of EDS but they all have a few symptoms in common, such as loose joints and elastic skin that bruises easily. Even with these com

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

mon symptoms, each type of EDS has specific symptoms. For example, the symptoms of the classical type of EDS are primarily loose joints and elastic skin, while the primary symptoms of vascular EDS are usually thin e

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

Examples of combination products may in

astic skin that you can see the veins through, with the risk of blood vessels rupturing as you age.

Because Ehlers-Danlos syndrome is genetic, there is no cure, but there are treatment options. If you or someone yo

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

know has been diagnosed with EDS, there are some basic things you can do to help with the disease. You can take vitamin C to reduce the intensity of symptoms of some EDS types, exercise, make sure to receive yearly

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

eye exams, take steps to protect your joints and avoid unneeded sun exposure. You can also take prescription medicine for the pain and inflammation in your joints.

The most commonly prescribed medicines are pain re

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

Combination pro

ievers and nonsteroidal anti-inflammatory drugs (NSAIDs). All NSAIDs have certain risks associated with them. The most common complaint is stomach problems, such as ulcers and heartburn. Because of these problems,

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

it is recommended that you do not take NSAIDs on an empty stomach. Even over the counter versions of NSAIDs (Advil or Motrin) can have these side effects, so for mild pain relief doctors often recommend acetaminophe

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

(Tylenol). This over the counter drug is not an NSAID, so it can be safely taken with most prescription drugs. There are limits to the amount of acetaminophen you can take in a day though. If the allowed daily am

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

unt of acetaminophen does not relieve your pain completely, your doctor will most likely give you a prescription for pain relievers.

A good strategy for preventing some joint problems is to protect your joints. The

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

e are several ways to accomplish this. The first way is to take a short break when doing a repetitive task such as typing, or switch to a different task for a short while. For example, if you work in an office and

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

pend most of your time typing, you can either take a 15 minute break from work or you can make copies or file papers for 15 to 20 minutes. Another way to protect your joints is to use them in the proper manner to av

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

Following aspects would a

oid stress on them. This means carrying a heavy box near your center of gravity (your waist for most people) or, if you have a bulky load, have someone help you carry your load. You can also use different products

dd to the challenges in developing combination products:

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

o help with some daily tasks. You can use a cane for extra stability when you walk, a wagon or cart to help carry grocery/shopping bags from your car to the house, or a grab bar in the shower to help you get in or o

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

t of the bathtub.

Some other treatment options for EDS are eye exams, taking vitamin C supplements, reducing sun exposure, exercise and surgery. People with EDS should get yearly eye exams because nearsightedness i

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

common among EDS sufferers and can be easily fixed with eyeglasses or contact lenses. Kyphoscoliosis EDS sufferers are especially at risk for eye problems and should see a doctor who has EDS experience. Some EDS s

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

fferers have experienced success with vitamin C reducing the intensity of their symptoms. Avoiding sun exposure is important because of the skin problems associated with EDS. The best way to avoid the sun while mai

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

Professional from academic institutions, pharmaceutical industries, health care indust

taining a normal schedule is to wear long pants, long sleeves and a wide-brimmed hat and put sunscreen on the remaining exposed skin. A sunscreen with a sun protection factor (SPF) of at least 15 is best. The point

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

of an exercise program as a treatment option for EDS is to improve joint stability. Exercise accomplishes this by strengthening the muscles supporting the joint. Speak with your doctor for the best exercises for yo

.

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

, because you should avoid any exercise that puts stress on your joints. The final option, surgery, is often used as a last resort. If surgery is used, it is often to correct fractures or dislocated joints. You sh

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

Companies that provide selfless information through particip

uld always tell your surgeon that you have EDS when you are scheduled for surgery. This way they can avoid using stitches to close your wound because your skin is more likely to tear than someone not affected by EDS

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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