Advice Pool - Health and Fitness

Recovery from drug addiction and alcohol addiction is stressful in the best of circumstances. The addict/alcoholic wishes that they could fast forward time and have all the past negative hi

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

story behind them, overnight in fact would be preferable. The watchful eyes of family, friends and employers take their toll and the minutes seem to tick by in slow motion as the discomfort

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

Examples of combination products may in

for all involved still remains. One important thing for the recovering addict to remember is that their concept of time is a bit warped.

Take for instance their using. If you ask an addic

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

or alcoholic if they are currently using because their behavior indicates that may be the case, they will often state “Oh I haven’t used in a long time!” If pushed to elaborate what consti

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

tutes a long time it may often be a day or two at most. To the addict that IS a long time. To those around him or her it is an extremely short amount of time and they are still holding thei

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

Combination pro

r breath waiting for the other shoe to drop.

In early recovery each day may deem to drag on uncomfortably. Preoccupation with wanting to use drugs or alcohol fights against determination t

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

be drug and alcohol free. On top of that, a whole new way of living is being learned a minute, an hour and a day at a time. As they look around them they might feel resentful for how easy

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

others are just sailing through the day when for them it feels as though it will never end. They think to themselves “I have to try to do this the rest of my life?”

When recovery is the go

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

al it is important to gain acceptance of the truth that time takes time. There are only twenty four hours in any given day, 1440 minutes and 86,400 seconds. Just because the recovering alco

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

olic and addict would like it to be less and for their journey on the road to recovery to be further along does not change the physical aspect of time. It simply is what it is. That is why

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

“One Day at a Time” is such an important slogan in twelve step recovery.

Almost every recovering addict and alcoholic is coming from a place of instant gratification. They are used to goin

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

Following aspects would a

g with their impulses and the consequence be damned. Now a whole new way of living is attempted. The recovering person is learning to delay gratification and substitute worthwhile pursuits

dd to the challenges in developing combination products:

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

or the drink or drug of choice that has been the focus for so long. That takes practice and it takes TIME.

Having a plan for each day can keep someone new to recovery occupied throughout t

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

he crucial first weeks and months of recovery. That is why there are so many support meetings for alcohol and drug addiction. Other recovering addicts and alcoholics well remember the early

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

days and how slowly they seemed to move at times. The hour or so they spend together may well be one less hour spent staring at the clock wondering if they are going to make it.

If it is

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

ough to get out to many meetings and you have access to the computer there are even meetings on line. The phone is invaluable as no one understands this somewhat warped perspective of time

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

Professional from academic institutions, pharmaceutical industries, health care indust

better than another recovering person. Sharing the frustrations with how slow time may “seem” to be passing can be helpful. Gaining insight as to how others have survived it may be life-sav

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

ing.

It is as important to remember that many people want the addict or alcoholic to succeed. They often have a truer sense of how much time has really passed. As the days and then weeks a

.

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

d then months pass by without the ensuing chaos brought about by the addict, these folks will begin to relax. The addict and alcoholic will begin to relax as well as they have put a signifi

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

Companies that provide selfless information through particip

cant amount of time between themselves and their last episode of using. Recovery from drug addiction and alcohol is not easy but it will help to keep a true perspective of the value of time

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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