Advice Pool - Health and Fitness

There are certain important factors to consider when developing an asthma treatment plan. None of those factors are more important th

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

an having the medications on hand when you need them. Nothing is more alarming when away from home than to realize the drugs needed t

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

Examples of combination products may in

o end an asthma attack are safely back at home on the kitchen counter.

With the recent advancements in medications and knowledge conc

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

erning asthma over the last few decades, many people have become comfortable living with the illness. This no doubt is caused by havi

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

ng an effective asthma treatment plan that has limited the number and severity of the attacks.

At this point, it may be almost second

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

Combination pro

nature to assume that an asthma attack will not happen. This is a dangerous assumption especially when the person with asthma is a y

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

oung child. He simply never know when they may come in contact with something in the environment that may cause an attack.

The state

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

ent that you didn't think that they would need their medicine rings hollow at best while your son or daughter is gasping for air. Chi

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

ldren count on us to be proactive with their care and this is especially true if they are suffering from asthma.

It's important to ke

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

ep your doctor updated on the effects of living with asthma and how effective the current asthma treatment program is working. Issues

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

such as the severity of the attacks is important to determine if the treatment plan needs adjusted.

Another important consideration

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

Following aspects would a

is the number and duration of attacks experienced. Try to keep a journal or log that will explain the details of each attack. These

dd to the challenges in developing combination products:

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

details should include

1. Duration of the attack. How long would you estimate the asthma attack to have lasted. Was the attack min

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

utes, seconds, etc.

2. Severity of the attack. How difficult was the attack on the asthma patient. I realize this is subjective bu

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

a severe attack is different than one that starts and is quickly controlled using available medicines, etc.

3. Treatment. What if

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

anything was done to address the asthma attack? What actions were taken to control the situation? This can be important in fine tun

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing a treatment plan.

4. Causation. Was there any specific trigger that might have brought on an attack? It may not be clear but d

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

etails may give some indication of the cause. A cold and windy day may bring on an asthma attack.

Having this information at your ne

.

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

xt doctor's appointment will go a long way in determining if the asthma treatment program currently being used, is effective or needs

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

Companies that provide selfless information through particip

to be adjusted. It's only by having consistent information and feedback can your doctor fine tune your personal asthma treatment plan

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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