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As I have mentioned in several of previous articles, addiction to opiates is chronic disease of the brain and should be managed as s

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

uch. It is usually the result of a combination of by genetic, psychosocial and environmental factors that ultimately lead to the de

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

Examples of combination products may in

velopment of this relapsing disease. Now that we agree that it is a disease shouldn't we treat it as such?

Unfortunately, although

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

many of the professionals working in the addiction field agree with this fact they still adopt of the mind set of our great grandfat

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

hers who looked down on those patients and considered addiction as an immoral sin and that addicts should repent. Some of the drug

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

Combination pro

reatment programs are resistant to prescribing medications indicated for addiction treatment, rather, they place those patients in w

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

hat looks like a lock down atmosphere and strip them of their ability to make decisions or communicate with certain people. While t

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 approach may be needed in some cases to avoid external influences on patients as the facility implement their treatment protocols

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

, it should not be generalized. Moreover, patients would be more receptive to the counseling efforts implemented in those facilitie

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

if they were comfortable and not suffering from the sever pains and aches associated with withdrawals from opiates.

What do you th

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

ink will happen once those patients are released back into the society where all the triggers associated with addiction reside?

Als

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

Following aspects would a

o have you ever seen a diabetic who is not very compliant with their doctor's recommendations placed in a diabetic rehab?

Treatment

dd to the challenges in developing combination products:

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

should be individualized and as recovery moves forward patients should gradually be empowered to take control of their life in order

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

to eventually become productive members of the society.

In contrast, the outpatient programs using Buprenorphine, implement an app

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

oach which deals with addiction as a chronic relapsing disease that needs medical treatment in the form of medications in addition t

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

o psychosocial rehabilitation. While being on Buprenorphine, patients are relieved from the dreadful symptoms of withdrawals and cr

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

Professional from academic institutions, pharmaceutical industries, health care indust

vings. This helps patients develop the interest and passion to participate in their rehabilitation process and makes the education

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

efforts on our parts much easier.

The stigma imposed by our society on patient suffering from addiction has a profound negative imp

.

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

ct on the recovery process. We hope that through education, research and solid evidence the medical community would be able to chang

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

Companies that provide selfless information through particip

e the views and beliefs of the society and some of the professionals in order to provide the best treatment approach to our patients

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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It was in Orlando, 2005, when the same mentor suggested everyone at the conference publish an e-zine and create a database. I agreed. But I didn't know how to produce one. Another repeat performance...

When you list your home for sale, the objective is to get the most money in your pocket as possible. It seems intuitive that you would get the most money by paying the least money to get it sold. Reality, however, is that you get what you pay for.

So often we are given reports and feed supposed research data from academia which is indeed nothing short of pure horseshit. Rarely do we call academic research into question, yet we need to. Why? Well we see that more than 60% of the Chinese students admit to cheating on data in research projects.

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